DRUG REGISTRATION SERVICE IN VIETNAM
ACTD required dox vietnam
T HE ASEAN C OMMON T ECHNICAL D OSSIER (ACTD) FOR THE R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SEP ART II: Q UALITYTABLE OF CONTENTSScope of the Guideline (2)Section A: Table of Contents (2)Section B: Quality Overall Summary (2)Section C: Body of Data 91. Drug Substance (9)2. Drug Product (14)Section D: Key Literature References (20)Scope of The GuidelineThis document is intended to provide guidance on the format of a registration applicationfor drug products regarding ASEAN CTR . This format is appropriate for NCE (NewChemical Entity), Biotech (Biotechnological Products), MaV (Major Variations), MiV(Minor Variations) and G (Generics). To determine the applicability of this format for aparticular type of product, applicant should consult with the appropriate NationalRegulatory Authorities. The "Body of Data" in this guideline merely indicates where theinformation should be located. Neither the type nor extent of specific supporting data hasbeen addressed in this guideline and both may depend upon national guidance and oraccepted leading international references (pharmacopoeias).For NCE and Biotech requirements please refer to the relevant ICH Guidelines.Section A: Table of ContentsA table of contents for the filed application should be provided.Section B : Quality Overall Summary (QOS)No. PARAMETERS COMPONENTS REQUIREMENTSNCE BIOTECH MaV MiV GS DRUGSUBSTANCES1 GeneralInformation1.1. Nomenclature − Information from the S1 V V V*V1.2.Structure − Structural formula, including relative andabsolute stereochemistry, the molecularformula, and the relative molecular mass.V V− Schematic amino acid sequence indicatingglycosylation sites or other post-translational modifications and relativemolecular mass as appropriate.V1.3. General Properties − Physico chemical characteristics and otherrelevant properties including biologicalactivity for biotech.V V V* VS2 Manufacture2.1. Manufacturer(s) Name and address of the manufacturer (s). V V V2.2. Description ofManufacturing Processand Process Controls − The description of the drug substancemanufacturing process and process controlthat represents the applicant's commitmentfor the manufacture of the drugsubstances.V VNo. PARAMETERS COMPONENTS REQUIREMENTSNCE BIOTECH MaV MiV G− Information on the manufacturing process,which typically starts with a vial(s) of thecell bank, and includes cell culture,harvest(s), purification and modificationreaction, filling, storage and shippingconditions.V2.3. Control of Materials − Starting materials, solvents, reagents,catalysts, and any other materials used inthe manufacture of the drugs subtanceindicating where each material is used inthe process. Tests and acceptance criteriaof these materials.V V− Control of source and starting materials ofbiological origin.V− Source, history and generation of the cellsubstrate .V− Cell banking system, characterisation andtesting.V− Viral safety evaluation. V2.4. Controls of Critical Stepsand Intermediates − Critical steps : Tests and acceptancecriteria, with justificationV V including experimental data, performed atcritical steps of the manufacturing processto ensure that the process is controlled.− Intermediates : Specifications andanalytical procedure, if any, forintermediates isolated during the process.V V− Stability data supporting storageconditions.V2.5. Process Validation and/orEvaluation Process validation and/or evaluation studies foraseptic processing and sterilization.V V2.6. Manufacturing ProcessDevelopment − Description and discussion of significantchanges made to the manufacturingprocess and/or manufacturing site of thedrug substance used in producing non-clinical, clinical, scale-up, pilot and ifavailable, production scale batches.V− The development history of themanufacturing process as described in S2.2.VNo. PARAMETERS COMPONENTS REQUIREMENTSNCE BIOTECH MaV MiV G S3 Characterisation3.1. Elucidation of Structureand other characteristics − Confirmation of structure based on e.g.synthetic route and spectral analyses.VCompendial requirements or appropriateinformation from the manufacturerV − Details on primary, secondary and higher-order structure and information onbiological activity, purity andimmunochemical properties (whenrelevant).V3.2. Impurities − Summary of impurities monitored ortested for during and after manufacture ofdrug substanceV VCompendial requirements or appropriateinformation from the manufacturerVS4 Control of Drug Substance4.1. Specification − Detailed specification, tests andacceptance criteria.V V− Compendial specification or appropriateinformation from the manufacturerV− Specify source, including as appropriatespecies of animal, type of microorganismetc.V4.2. Analytical Procedures − The analytical procedures used fortesting of drug substance.V VCompendial methods or appropriateinformation from the manufacturerV4.3. Validation of AnalyticalProcedures − Analytical validation information,including experimental data for theanalytical procedures used for testing thedrug substanceV VNon-compendial methods V4.4. Batch Analyses − Description of batches and results of theanalysis to establish the specification.V V4.5. Justification ofSpecification − Justification for drug substancespecification.V VNCE BIOTECH MaV MiV GS5 Reference Standards or Materials − Information on the reference standards orreference materials used for testing of thedrug substance .V V− Compendial reference standard. V* VS6 Container Closure System − Descriptions of the container closuresystems.V VS7 Stability − Stability report. V V− Literature data . V* VP DRUGPRODUCTP1 Description and Composition − Description V V V*V*V− Dosage form and characteristics.− Accompanying reconstitution diluent (s) ifany.− Type of container and closure used for thedosage form and reconstitution diluent (s),if applicable.Composition VVV*V*VName, quantity stated in metric weight ormeasures, function and quality standardreference.P2 PharmaceuticalDevelopment2.1. Information onDevelopment Studies − Data on the development studiesconducted to establish that the dosageform, formulation, manufacturing process,container closure system, microbiologicalattributes and usage instruction areappropriate for the purpose specified in theapplication.V V2.2. Components of the DrugProduct − Active ingredient• Justification of the compatibility ofthe active ingredient with excipientslisted in P1• In case of combination products,justification of the compatibility ofactive ingredients with each other.V V− Literature data. V* VNCE BIOTECH MaV MiV G− Excipients V VJustification of the choice of excipientslisted in P1, which may influence the drugproduct performance.2.3. Finished Product − Formulation Development V V VA brief summary describing thedevelopment of the finished product,(taking into consideration the proposedroute of administration and usage for NCEand Biotech).− Overages V V VJustification of any overage in theformulation(s) described in P1 .− Physicochemical and Biological Properties V V VParameters relevant to the performance ofthe finished product e.g pH, dissolution.2.4. Manufacturing ProcessDevelopment − Selection and optimisation of themanufacturing processV V − Differences between the manufacturingprocess (es) used to produce pivotalclinical batches and the process describedin P.3.2, if applicableV V2.5. Container ClosureSystem Suitability of the container closure system usedfor the storage, transportation (shipping) anduse of the finished product.V V V2.6. MicrobiologicalAttributes Microbiological attributes of the dosage form,where appropriateV V V* V2.7. Compatibility Compatibility of the finished product withreconstitution diluent(s) or dosage devices.V V V*Literature data VP3 Manufacture3.1. Batch Formula Name and quantities of all ingredients V V V* V3.2. Manufacturing Processand Process Control Description of manufacturing process andprocess controlV V V*V*V3.3. Control of Critical Stepsand IntermediatesTests and acceptance criteria V V VNCE BIOTECH MaV MiV G3.4. Process Validationand/or Evaluation Description, documentation, and results of thevalidation and/or evaluation studies for criticalsteps or critical assays used in themanufacturing process.V V VP4 Control of excipients4.1. Specifications − Specifications for excipients V VCompendial requirements or appropriateinformation from the manufacturerV* V4.2. Analytical Procedures − Analytical procedures used for testingexcipients where appropriate.V VCompendial requirements or appropriateinformation from the manufacturerV* V* V4.3. Excipient of Human orAnimal Origin − Information regarding sources and oradventitious agents.V VCompendial requirements or appropriateinformation from the manufacturerV* V* V4.4.Novel Excipients − For excipient(s) used for the first time in afinished product or by a new route ofadministration, full details of manufacture,charcterization and controls, with crossreference to supporting safety data (non-clinical or clinical)V V P5 Control of Finished Product5.1. Specification − The specification(s) for the finishedproduct. V V V*V*V5.2. Analytical Procedures − Analytical procedures used for testing thefinished product V V V*V*V5.3. Validation of AnalyticalProcedures − Information including experimental data,for the analytical procedure used fortesting the finished productV VNon-compendial method V V V*V*V Verification of compendial methodapplicability - precision & accuracyV* V* V5.4. Batch Analyses − Description and test results of all relevantbatches.V VNCE BIOTECH MaV MiV G5.5. Characterisation ofImpurities − Information on the characterisation ofimpuritiesV VCompendial requirements or appropriateinformation from the manufacturerV* V5.6. Justification ofSpecification(s) − Justification of the proposed finishedproduct specification(s).V VCompendial requirements or appropriateinformation from the manufacturerV* VP6 Reference Standards or Materials − Information on the reference standards orreference materials used for testing of thefinished product.V VCompendial requirements or appropriateinformation from the manufacturerV* VP7 Container Closure System − Specification and control of primary andsecondary packaging material, type ofpackaging and the package size, details ofpackaging inclusion (e.g. desiccant, etc) V V V*V*VP8 Stability Stability report : data demonstrating thatproduct is stable through its proposed shelflife.V V V* VCommitment on post approval stabilitymonitoringP9 Product InterchangeabilityEquivalence evidence − In Vitro V* VComparative dissolution study as required− In Vivo V* VBioequivalence study as requiredremarks : * if requiredNCE : New Chemical EntityBiotech:BiotechnologicalProductsMaV:MajorVariationMiV:MinorVariationG:GenericsSection C: Body of DataS DRUG SUBSTANCES 1 General InformationS 1.1 Nomenclature• International non–proprietary name (INN)• Compendial name if relevant• Registry number of chemical abstract service (CAS)• Laboratory code (if applicable)• Chemical name(s)S 1.2 Structural formulaNCE :The structural, including relative and absolute stereochemistry, the molecular formula, and the relative molecular mass should be provided.Biotech :The schematic amino acid sequence indicating glycosylation sites or other post-translational modifications and relative molecular mass should be provided, as appropriate.Generic :Compendial requirement or equivalent information from the manufacturer.S 1.3 General PropertiesA list should be provided of physicochemical and other relevant properties of the drug substance, including biological activity for Biotech.Reference ICH Guidelines: NCE : Q6A, Biotech : Q6BS 2 ManufactureS 2.1 Manufacturer(s)Name and full addresses including the city and country of the manufacturer of active ingredient.S 2.2 Description of Manufacturing Process and Process ControlsThe description of the drug substances manufacturing process represents the applicant’s commitment for the manufacture of drug substances. The following information should be provided to adequately describe the manufacturing process and process controls:NCE:• A schematic flow diagram of the synthetic process(es) should be provided that includes molecular formulae, weights and yields, chemical structures of starting materials, intermediates, reagents and drug substance reflecting stereochemistry, and identifies operating conditions and solvents.• A sequential procedural narrative of the manufacturing process that provides quantities of raw materials, solvent, catalysts and reagent reflecting the representative batch scale,and includes process controls, equipment and operating conditions, such as temperature, pressure, pH, time etc.• Alternative process should be explained and described with the same level of details as the primary process. Reprocessing steps should be identified and justified.Biotech:• Information on the manufacturing process, which typically starts with a vial(s) of the cell bank and includes cell culture, harvest(s), purification and modification reaction, filling storage and shipping conditions.Reference ICH Guidelines : Q5A, Q5B and Q6B.S 2.3 Control of MaterialsMaterial used in the manufacture of the drug substance (e.g., raw materials, starting materials, solvents, reagents, catalysts) should be listed identifying where each material is used in the process. Information on the quality and control of these materials should be provided. Information demonstrating that materials (including biologically-sourced materials, e.g., media components, monoclonal antibodies, enzymes) meet standards appropriate for their intended use (including the clearance or control of adventitious agents) should be provided, as appropriate. For biologically-sourced materials, this can include information regarding the source, manufacture, and characterization.Reference ICH Guidelines : NCE : Q6A; Biotech : Q6BBiotech:• Control of source and starting materials of biological Origin.Summaries of viral safety information for biologically -sourced materials should be provided.• Source, history and generation of the cell substrate.Information of the source of the cell substrate and analysis of the expression construct used to genetically modify cells and incorporated in the initial cell clone used to develop the Master Cell Bank should be provided as described in Q5B and Q5D.• Cell banking system, characterization and testing.Information on the cell banking system; quality control activities and cell line stability during production and storage (including procedures used to generate the Master and Working Cell Bank(s)) should be provided as described in Q5B and Q5D.Reference ICH Guidelines : Q5A, Q5B, Q5C, and Q5DS 2.4 Controls of Critical Steps and IntermediatesCritical steps: Tests and acceptance criteria, with justification including experimental data, performed at critical steps of the manufacturing process to ensure that the process is controlled.Intermediates: Specifications and analytical procedure, if any, for intermediates isolated during the process.Reference ICH Guidelines : Q6A, Q6B,Additionally for Biotech: Stability data supporting storage conditions.Reference ICH Guidelines : Q5CS 2.5 Process Validation and/or EvaluationProcess validation or evaluation studies for aseptic processing and sterilization.BiotechSufficient information on validation and evaluation studies to demonstrate that the manufacturing process (including reprocessing steps) is suitable for its intended purpose and to substantiated selection of critical process controls (operational parameters and in-process test) and their limits for critical manufacturing steps (e.g.cell culture, harvesting, purification, and modification).Information should include a description of the plan for conducting the study and the results, analysis and conclusions from the executed study(ies). The validation of corresponding assay and analytical methods should be cross-referenced or provided as part of justifying the selection of critical process controls and limits.For manufacturing steps, intended to remove or inactive viral contaminants, the information from evaluation studies should be providedReference ICH Guidelines Q5A, Q5D, and Q6BS 2.6 Manufacturing Process DevelopmentNCEDescription and discussion of significant changes made to the manufacturing process or manufacturing site of the drug substance used in producing non-clinical, clinical scale-up, pilot and if available, production scale batches.Reference ICH Guidelines : Q3ABiotechThe developmental history of the manufacturing process, as described in S. 2.2, should be provided. The description of change(s) made to the manufacture of drug substance batches used in support of the marketing application (e.g. non-clinical or clinical studies) including for example, changes to the process or critical equipment. The reason for the change should be explained. Relevant information on drug substance batches manufactured during development, such as the batch number, manufacturing scale and use (e.g. stability, non clinical reference material) in relation to the change. The significance of change should be assessed by evaluating its potential to impact the quality of the drug substance (and/or intermediate, if appropriate). For manufacturing changes that are considered significant, data from comparative analytical testing on relevant drug substance. A discussion of the data including a justification for selection of the test and assessment of results, should be included.Testing used to assess the impact of manufacturing changes on the drug substance(s) and the corresponding drug product(s) may also include non-clinical and clinical studies in other modules of the submission should be included.Reference ICH Guidelines : Q6BS 3 CharacterizationS 3.1 Elucidation of Structure and CharacteristicNCE :Confirmation of structure based on e.g. synthetic route and spectral analysis.Information on the potential for isomerism, the identification of stereochemistry, or the potential for forming polymorph should also be included.Reference ICH Guidelines : Q6ABiotech:Details on primary, secondary and higher-order structure and information on biological activity, purity and immunochemical properties (when relevant). Reference ICH Guidelines : Q6BMaV, MiV, G:Compendial requirement or equivalent information from the manufacturer.S 3.2 ImpuritiesInformation on impurities should be provided.Reference ICH guidelines : Q3A, Q3C, Q5C, Q6A and Q6BGeneric :Compendial requirement or equivalent information from the manufacturer.S 4 Control of Drug SubstanceSpecification and justification of specification (s).Summary of analytical procedure and validation.S 4.1 SpecificationDetailed specification, tests and acceptance criteria for the drug substance should be provided.Reference ICH Guidelines NCE : Q6ABiotech :Specify source, including as appropriate species of animal, type of microorganism, etc. Reference ICH Guidelines : Q6BMaV, MiV, G :Compendia specification are adequate. Indicate clearly whether the drug substance is purchased based on specification with a certificate of analysis, or tested by applicant.S 4.2 Analytical ProceduresThe analytical procedure used for testing the drug substance should be provided in sufficient detail to enable reproducible testing by another laboratory.Reference ICH Guidelines : NCE : Q2A ; Biotech : Q6BMaV, MiV, G :Compendial requirement or equivalent information from the manufacturerS 4.3 Validation of Analytical ProceduresAnalytical validation information, including experimental data for the analytical procedure used for testing the drug substance should be provided. Typical validation characteristics to be considered are selectivity, precision (repeatability, intermediate precision and reproducibility), accuracy, linearity, range, limit of quantitation, limit of detection, robustness, and system suitability.Reference ICH Guidelines : NCE : Q2A and Q2B ; Biotech : Q6BMaV, MiV, G :Required for non-compendial method onlyReference ASEAN Guideline for Validation of Analytical ProcedureS 4.4 Batch AnalysesDescription of batches and results of batch analyses should be providedReference ICH Guidelines : NCE : Q3A, Q3C and Q6A ; Biotech : Q6BS 4.5 Justification of SpecificationJustification for the drug substance specification should be provided.Reference ICH Guidelines : NCE : Q6A ; Biotech : Q6BS 5 Reference Standards or MaterialsQuality information of Reference standard or material used for testing of substance should be provided.Reference ICH Guidelines : NCE : Q6A ; Biotech : Q6BMaV, MiV, G :Compendial requirement or equivalent information from the manufacturerS 6 Container Closure SystemNCE and Biotech :A descriptions of the container closure systems should be provided, including the identity of materials of construction of each primary packaging component, and each specifications. The specifications should include description and identification (and critical dimensions with drawings where appropriate). Non-compendial methods (with validations) should be included where appropriate.For non-functional secondary packaging components (e.g. those that do not provide additional protection nor serve to deliver the product), only a brief description should be provided. For functional secondary packaging components, additional information should be provided.The suitability should be discussed with respect to, for example, choice of materials, protection from moisture and light, compatibility of the materials of construction with the drug substance, including sorption to container and leaching, and/or safety of materials of construction.S 7 StabilityStability Summary and ConclusionThe types os studies conducted, protocols used, and the results of the studies should be summarized. The summary should include results, for example, from forced degradation studies and stress conditions, as well as conclusions with respect to storage conditions and retest date or shelf-life, as appropriate.Reference ICH Guidelines : Q1A (R2), Q1B, and Q5CPost-approval Stability Protocol and Stability CommitmentThe post-approval stability protocol and stability commitment should be provided. Reference ICH Guidelines : Q1A (R2) and Q5CStability DataResults of the stability studies (e.g. forced degradation studies and stress conditions) should be presented in an appropriate format such as tabular, graphical, or narrative. Information on the analytical procedures used to generate the data and validation of these procedures should be included.Reference ICH Guidelines : Q1A (R2), Q1B, Q2A, Q2B, and Q5CMaV, MiV, G:Manufacturer stability data or equivalent informationP DRUG PRODUCTP 1 Description and CompositionA description of the drug product and its composition should be provided. The information provided should include, for example :• Description of the dosage form;• Composition, i.e., list of all components of the dosage form, and their amount on a per-unit basis (including overages, if any) the function of the components, and a reference to their quality standards (e.g., compendial monographs or manufacturer’s specifications) • Description of accompanying reconstitution diluent(s); and• Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable.Reference ICH Guidelines : NCE : Q6A ; Biotech : Q6BP 2 Pharmaceutical DevelopmentP 2.1 Information on Development StudiesNCE and Biotech:The section of Pharmaceutical Development presents information and data on the development studies conducted to establish that the dosage form, the formulation manufacturing process, container closure system, microbiological attributes and usages instruction are appropriate for the purpose specified in the application. The studies described here are distinguished from routine control tests conducted according to specifications. Additionally, this section should identify and describe the formulation and process attributes (clinical parameters) that may influence batch reproducibility, product performance anddrug product quality. Supportive data and result from specific studies or published literature may be included within or attached to the Pharmaceutical Development Section. Additional supportive data may be referenced to the relevant non-clinical sections of the application. Reference ICH Guidelines : NCE : Q6A; Biotech : Q6BP 2.2 Component of Drug ProductP 2.2.1 Active IngredientsNCE and Biotech:The compatibility of the drug substances with excipients listed in Item 2.1 should be discussed. Additionally, key physicochemical characteristics (e.g. Water content, solubility, particle size distribution, polymorphic or solid state form) of the drug substance, which may influence the performance of the drug product should be discussed.MaV, MiV, G:Literature data is sufficient.P 2.2.2 ExcipientsThe choice of excipients listed in Item P 1, their concentration and characteristics which influence the drug product performance, should be discussed relative to their respective function.P 2.3 Finished ProductP 2.3.1 Formulation DevelopmentA brief summary describing the development of the drug product should be provided, taking into consideration the proposed route of administration and usage. The differences between clinical formulations and the formulation (i.e. Composition) described in Item P 1 and P 2 should be discussed. Results from comparative in vitro studies (e.g. dissolution) orcomparative in vivo studies (e.g., bioequivalence) should be discussed when appropriate.P2.3.2OveragesAny overages in the formulation(s) described in Item P 1 should be justified.P 2.3.3 Physicochemical and Biological PropertiesParameters relevant to the performance of the drug product such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency and immunological activity should be addressed.P 2.4 Manufacturing Process DevelopmentThe selection and optimization of the manufacturing process described in Item P 3.2, in particular its critical aspects, should be explained. Where relevant, the method of sterilization should be explained and justified.Differences between the manufacturing process(es) used to produce pivotal clinical batches and the process described in Item P 3.2 that can influence the performance of the product should be discussed.Generics : refer to P.3.2.P 2.5 Container Closure SystemThe suitability of the container closure system used for the storage, transportation (shipping) and use of the drug product should be discussed as necessary. This discussion should consider e.g. choice of materials, protection from moisture and light, compatibility of the materials of construction with the dosage form including sorption to container and leaching safety of materials of contraction, and performance such as reproducibility of the dose delivery from the device when present as part the drug product.P 2.6 Microbiological AttributesWhere appropriate, the microbiological attributes of the dosage from should be discussed including the rationale for not performing microbial limits testing for non-sterile products, and the selection and effectiveness of preservatives systems in product containing anti microbial preservatives. For sterile products, the integrity of the container closure system to prevent microbial contamination should be addressed.P 2.7 CompatibilityThe compatibility of the drug product or reconstitution diluents(s) or dosage devices, e.g. precipitation of drug substance in solution, sorption on injection vessels and stability should be addressed to provide appropriate and supportive information for the labeling.MaV, MiV, G :Literature data are acceptableP 3 ManufactureP 3.1 Batch FormulaThe formula with name and quantities of all ingredients (active and otherwise) including substance(s) which are removed in the course of manufacture should be included:• The actual quantities (g, kg, liters) etc. of ingredient should be stated.。
越南农药登记技术资料要求和审查要点
第43卷第2期 世 界 农 药2021年2月 World Pesticides ·45·收稿日期：2021-01-09。
越南农药登记技术资料要求和审查要点赵一杰1，李 颖2(1.中国农药工业协会，北京 10010；2.济南天昱农业科技有限公司，济南 250100)摘要：越南植保局通过对农药原药、活性成分各项数据进行评估，以确认原药的化学属性、分析准确性、生产稳定性、毒理和环境安全性；通过对制剂产品的技术资料进行审核，确认制剂产品质量和加工工艺的稳定性、毒理安全性和药效的有效性。
对越南登记技术资料的要求进行解读，并对越南植保局评审的要点做出了分析和评价。
关键词：越南；农药登记；技术资料；审查要点中图分类号：TQ450 文献标志码：A 文章编号：1009-6485(2021)02-0045-04 DOI ：10.16201/10-1660/tq.2021.02.05Data requirements and key points of assessment foragrochemical registration in VietnamZHAO Yijie 1, LI Ying 2(1. China Crop Protection Industry Association, Beijing 10010, China;2. Jinan Sunrise Agrotech Co., Ltd., Jinan 250100, China)Abstract: The data of technical products and active ingredients is evaluated by Plant Protection Department of Vietnam to confirm the chemical properties, accuracy of analytical methods, stability of production and the toxicology and environmental safety. For the assessment of technical data of formulation, the quality of end products, stability of the processing, the safety and good efficiency will be assured. This article interprets the data requirement of Vietnam Plant Protection Department and analyses the key points of assessment.Keywords : Vietnam; agrochemical registration; technical data; key points of assessment越南农药市场2020年估值6.7亿美元。
越南卫生部药品注册规定
越南药品注册规定（越南卫生部第3121/2001/QD-BYT号决定）为便于对药品的生产和流通实施统一的国家管理，保障药品的安全、有效和质量可控性，越南卫生部（MOH）决定颁布关于人用防病、治病、补养药品注册的规定（简称为《药品注册规定》）。
解读：越南的药品注册归口越南卫生部管理。
总则第一条在越南生产和流通的人用防病、治病、补养药品必须进行注册并由卫生部给予注册编号。
在特殊场合下（用于防疫、抗灾的药品及孤儿药），卫生部将依据实际情况允许流通未给予注册编号的药品。
解读：各类药品均须注册，由卫生部颁给注册编号，类似于我国的批准文号。
非常情况下，没有注册编号的药品亦可流通。
第二条调整范围及适用对象2.1 调整范围－——国内外具备生产条件的药品生产企业生产的药品在越南上市前均必须注册。
－——科研院所研制的新药，在待技术转让期间，若本单位充分具备生产条件，可申请注册在本单位内生产销售。
解读：与我国不同，具备生产条件的科研院所研制成功的新药在转让前可以生产。
－——授权生产（under-license）的药品只能在越境内符合药品生产质量管理规范（GMP）的药品生产企业进行生产。
解读：貌似我国的委托生产。
－——医疗机构依照诊治病处方配制/生产的服务于本单位诊治疾病的药品,不能在市场上流通.医疗机构的领导必须对药品的配方、生产规程、质量标准及药品的安全有效性负责。
解读：貌似我国的院内制剂，医院领导负责制。
2.2 适用对象以下各单位可以进行药品注册，在越南进行药品生产和流通：－——越南国内各药品生产企业；－——从事药品贸易的国内企业，获准在药品领域内活动的外国公司。
解读：越南国内的药品生产和经营企业，以及有权限的外国公司均可申请药品注册。
这里没有提及科研院所，但从前面条款中不难看出，科研院所、医院等是可以注册药品的。
第三条在本规定内，一些术语做如下理解：3.1 药品是指用于人防病、治病、减轻病情、诊断疾病或调整机体生理职能的产品。
企业经营范围（Businessscope）
企业经营范围（Business scope）Business scope DaquanThe scope of enterprise management is divided into the licensed management project and the general management project:1, permission project refers to the enterprise before applying for registration, according to laws and administrative regulations, the State Council decided to report to the relevant departments approved the project, that is, the need for pre - and post licensing projects.2, the general management project refers to the project without approval, enterprises can apply for their own. The following is our company agent business scope commonly used, in order to provide your reference.Disclaimer: the scope of business is determined according to the GB industry standard of People's Republic of China and the relevant enterprise registration laws and regulations. The trustee only provides reference opinions, and the final approval is based on the approval of the industrial and commercial registration authorities.Trade name and business scope of registered company (1) trade categoryIndustry name: trade, trade, industry and trade, electrical appliances, clothing, paper, stationery, hotel supplies, food and so on.Business scope: daily necessities, cosmetics, jewelry, chemical raw materials and products (except dangerous goods), chemicals, textile raw materials (except cotton), textiles, garments, bedding, kitchen utensils, gifts and crafts (except gold and silver), toys, hardware, office equipment, office supplies, body building equipment and equipment, plastic products, leather products, sports supplies, hotel supplies, labor protection products (except special control), flowers, pulp and paper, cultural paper, printing equipment and supplies (except ink), feed, rubber products, packaging materials, biological products, native herbs, spices.(health permit and alcohol license):Agricultural and sideline products, food, beverage, packaging stereotypes stereotypes packaged health products, candy, cakes, puffed food, dairy products, tea, edible oil, native products, South goods, food additives, bottled wine etc..Trade name and business scope of registered companies (two) tradeTrade name: trade, trade, industry and trade, electronics, building materials, computers, electronics, electrical appliances, medical equipment, oral equipment, etc..Business scope: electronic products, teaching equipment, lighting products, transportation equipment, wire and cable, electronic products, household appliances, instruments, electrical equipment, electronic components, refrigeration equipment, communications equipment, computers andaccessories, communication products, computer peripheral equipment, printing equipment, computer supplies, computer software, digital products, the network game cards, laboratory equipment, ship fittings.(medical license):I I: medical X - ray equipment, medical ultrasonic instruments and related equipment, operation room, emergency room treatment, laboratory equipment and apparatus, analysis of clinical laboratory instruments and diagnostic reagents, extracorporeal circulation and blood processing equipment, II, III, II: Material: Department of Stomatology and basic medical laboratory equipment, III class: medical X - ray equipment and ancillary equipment and accessories, equipment and utensils, Department of Stomatology, disinfection and sterilization equipment and apparatus (with qualification)Trade name and business scope of registered companies (three) tradeTrade name: trade, trade, industry and trade, building materials, acoustics, automobile, security, fire fighting, electric power, air conditioning, electronics, etc..Business scope: fire fighting equipment, fire fighting equipment, power equipment, security products, security monitoring and control system of equipment, energy saving products, central air-conditioning equipment, refrigeration equipment, compressors and accessories, measuring equipment, engineering machinery fittings, pipe fittings, mechanicalequipment, clean equipment, filtration equipment, stage lighting, audio, radio and video conferencing systems, security monitoring system, light system, weighing equipment (with qualification) video and audio network equipment, audio-visual equipment, electric tools, automobiles, motorcycles, agricultural vehicles and accessories, automotive beauty, car decoration materials, electric bicycle, electric bicycle accessories, steel. Building materials, decorative materials, metal materials (in addition to tungsten, antimony, tin, gold), mineral products, building decoration materials. Plumbing equipment, ceramic products, sanitary ware.Name and scope of business of registered company (four) service categoryTwo, trade name: enterprise management consulting, business planning, business consulting, business (information) services, management consulting, translation services, air services, ticketing, real estate information consulting (investment), culture consulting, education information consulting, second-hand car appraisal, investment, international freight agency.Business scope: enterprise management consulting, product information consulting, market research, marketing planning, corporate image planning, consulting, project business etiquette services, conference and exhibition services, commodity price information consulting, consumer goods market information consulting, investment consulting; hotel management consulting, hotel human resource development,cultural planning, cultural exchange activities real estate; real estate investment consulting, information consulting, real estate consulting, real estate commodity trading, brokerage, agency, brokerage; translation services; transportation information, travel information, booking tickets, air tickets and hotel rooms, celebration planning, all kinds of entertainment planning services, stage art modeling planning. Internal training, air freight consultation; cultural consultation, foreign language translation services, domestic marriage Introduction; information consultation, preschool education tutor service; second-hand car appraisal agency, motor vehicle registration, second-hand car trading, car loan information consultation; property management, hotel, construction, garden greening engineering, intelligent engineering, security monitoring project investment; (10 million) to undertake maritime, aviation and land import export goods in the international transport agency business, courier service. (letters and letters are not included)Registered company's name and scope of business (five) technologyFirst, the industry name: architectural design consulting; engineering information consulting; landscape design; blasting technology.Business scope: indoor and outdoor decoration engineering design, engineering consulting services, leasing of construction machinery, instrument repair, highway construction project bidding consulting, engineering consulting, construction planning and design consulting,interior design consulting, construction consulting, greening engineering, decoration engineering consulting, engineering cost consulting, project bidding the agent (with qualification certificate); landscape design consultation; blasting engineering technology consulting.Two, industry name: advertising, advertising planning, film and television culture communication.Business scope: design, production, agent, publishing all kinds of domestic advertising; (with qualification) planning and development of cultural industry projects, planning and implementation of large-scale activities of film culture, film and television products exchange, trading.Three, industry name: Computer Science and technology, network technology.Business scope: computer hardware and software sales and technology development, technology transfer, technical services, computer repair and maintenance services, design and installation of electric engineering, integrated network cabling and installation, system integration, web design, computer graphic design, art design, computer graphic design, production, drawing, network technology development, technology transfer, technology consulting, technology services, technology transfer in the field of electronic technology, technology development and consulting services, security technology.Registered company's name and scope of business (six)technologyFirst, industry name: biotechnology, audio-visual technology development, agricultural science and technology, medical science and technology development, Chinese herbal medicine, forestry science and technology, bio energy.Business scope: research and development of biological products, technology transfer, technical services, modern agricultural breeding, aquaculture investment; construction planning, management consulting, cinema, cinema promotion and related equipment sales, professional theater, theater systems engineering design, installation, debugging, matching; (with qualification) consulting, agriculture project of light industry, agricultural project consulting, technology development, transfer, agricultural and sideline products processing technology research and development, technology transfer, drug development, technology consulting, technology transfer, technical services, medicine research and development consulting services,The application of drug registration service; medical science and technology project reporting services, pharmaceutical policy advisory services, health food technology development consulting services, new product planning advisory services, new academic promotion service, cultivation of Chinese herbal medicines, medical organization meeting planning, the pharmaceutical industry investment consulting, marketing in the original Chinese herbal medicine herbs, development of new products technology transfer, technical consultation and service; afforestation, forestry machinery, tractor, digging,planting flowers; (with quality) renewable energy technology development; (with the business site before operation).Registered company's name and scope of business (seven) technologyIndustry name: surveying, engineering construction, automobile maintenance service, decoration, basic engineering, building waterproof engineering, real estate development, property management, cleaning service.Business scope: engineering surveying, topographic surveying, cadastral surveying, pipeline measurement, measurement of real estate; (with qualification) of municipal engineering, hydropower installation engineering, landscape engineering, water fountain, grass seeding, seedling cultivation and sales; (with qualification) one or two car maintenance and repair; (by road transport business license Management) interior decoration engineering and foundation pit precipitation, the development of new technology, landslide, dam, tunnel shed irrigation, soft base reinforcement, design and development of Underground Garage Engineering; (with qualification) building waterproof engineering, building waterproof, anti-corrosion, insulation and decoration materials sales, development, manufacture and customer service service. Technology transfer (with qualification); real estate development; property management; (with qualification) (with qualification) cleaning cleaning, wall cleaning (except for high-altitude operation Carpet cleaning, air conditioning cleaning, dredging and plugging, air duct cleaning, stone maintenance, kitchen equipment cleaning, home cleaning and maintenance.。
越南药品管理制度
越南是一个东南亚发展中国家，其医疗保健系统在过去几十年中取得了巨大进步。
药品管理制度是医疗保健体系中至关重要的一部分，对保障人民的健康和生命安全起着至关重要的作用。
越南政府一直致力于加强药品管理制度，确保药品的质量、安全和有效性。
本文将介绍越南的药品管理制度，包括法律框架、监管机构、注册审批流程、药品安全监管和市场监管等方面的内容。
一、法律框架越南的药品管理法律框架主要由以下几部法律构成：1.药品管理法（Law on Drug Management）：药品管理法是越南最重要的药品管理法律，规定了药品的注册、生产、市场准入、进口出口、流通、监管等方面的规定。
2.药品法（Pharmacy Law）：药品法包括了药品的生产、批发、零售、处方、医疗保健机构等方面的规定。
3.药品法规（Drug Regulations）：药品法规是对药品管理法律进行具体细化和解释的相关规章。
4. 药品质量标准（Drug Quality Standards）：药品质量标准是对药品质量的具体监管标准，确保药品的质量符合国家标准和国际标准。
5.其他相关法律：包括《卫生法》、《医药设备管理法》、《食品安全法》等。
二、监管机构越南的药品管理体系主要由以下几个部门和机构共同负责：1. 越南药品管理局（Vietnam Drug Administration）：越南药品管理局是负责药品管理的主要监管机构，属于卫生部，主要职责是颁发、管理和监督药品的注册、生产、流通和使用。
2. 药品检定中心（Drug Testing Center）：药品检定中心负责对药品进行质量检验和控制，确保药品的合格。
3. 卫生部（Ministry of Health）：卫生部是越南卫生保健系统的管理机构，负责卫生保健政策的制定和协调，对药品管理具有重要的指导和协调作用。
4. 监管局（Inspectorate）：监管局是对药品市场进行监督和检查的机构，确保药品经营者和医药行业从业者遵守相关法律法规。
越南卫生部药品注册规定0416
越南药品注册规定（越南卫生部第3121/2001/QD-BYT号决定）为便于对药品的生产和流通实施统一的国家管理，保障药品的安全、有效和质量可控性，越南卫生部（MOH）决定颁布关于人用防病、治病、补养药品注册的规定（简称为《药品注册规定》）。
解读：越南的药品注册归口越南卫生部管理。
总则第一条在越南生产和流通的人用防病、治病、补养药品必须进行注册并由卫生部给予注册编号。
在特殊场合下（用于防疫、抗灾的药品及孤儿药），卫生部将依据实际情况允许流通未给予注册编号的药品。
解读：各类药品均须注册，由卫生部颁给注册编号，类似于我国的批准文号。
非常情况下，没有注册编号的药品亦可流通。
第二条调整范围及适用对象2.1 调整范围－——国内外具备生产条件的药品生产企业生产的药品在越南上市前均必须注册。
－——科研院所研制的新药，在待技术转让期间，若本单位充分具备生产条件，可申请注册在本单位内生产销售。
解读：与我国不同，具备生产条件的科研院所研制成功的新药在转让前可以生产。
－——授权生产（under-license）的药品只能在越境内符合药品生产质量管理规范（GMP）的药品生产企业进行生产。
解读：貌似我国的委托生产。
－——医疗机构依照诊治病处方配制/生产的服务于本单位诊治疾病的药品,不能在市场上流通.医疗机构的领导必须对药品的配方、生产规程、质量标准及药品的安全有效性负责。
解读：貌似我国的院内制剂，医院领导负责制。
2.2 适用对象以下各单位可以进行药品注册，在越南进行药品生产和流通：－——越南国内各药品生产企业；－——从事药品贸易的国内企业，获准在药品领域内活动的外国公司。
解读：越南国内的药品生产和经营企业，以及有权限的外国公司均可申请药品注册。
这里没有提及科研院所，但从前面条款中不难看出，科研院所、医院等是可以注册药品的。
第三条在本规定内，一些术语做如下理解：3.1 药品是指用于人防病、治病、减轻病情、诊断疾病或调整机体生理职能的产品。
世界各国药监局网站
List of Globally identified Websites of Medicines RegulatoryAuthorities ∗(as of November, 2009)AFRO ‐ Regional Office for Africa1.Algeria: http://www.ands.dz/pharmacie‐med/sommaire.htmpharmacovigilance: .dz/2.Angola: no website identified3.Benin: no website identified4.Botswana: .bw/ ‐ MoH ‐ no MRA5.Burkina Faso: .bf/SiteSante/ministere/sc/dgpml.html6.Burundi: website does not exist ‐ only MoH7.Cameroon: no website identified8.Cape Verde: no website identified9.Central African Rep: no website identified10.Chad: website does not existoros, The: no website identified12.Congo, The: no website identified13.Cote dʹIvoire: no website identified14.Democratic Republic of Congo: website does not exist15.Equatorial Guinea: no website identified16.Eritrea: website does not exist17.Ethiopia: .et/18.Gabon: website does not exist19.Gambia: no website identified20.Ghana: .gh/21.Guinea: no website identified22.Guinea‐Bissau: no website identified23.Kenya: /24.Lesotho: no website identified25.Liberia: no website identified26.Madagascar: no website identified27.Malawi: no website identified28.Mali: /29.Mauritania: no website identified30.Mauritius: .mu/portal/site/mih MIH ‐ no MRA∗ This list is indicative. WHO/EMP will be thankful for any correction and addition.31.Mozambique: website does not exist32.Namibia: .na/33.Niger: no website identified34.Nigeria: /35.Rwanda:.rw/index.php?option=com_content&view=article&id=6 2&catid=56:ministry‐taskforces&Itemid=136.Sao Tome & Principe: no website identified37.Senegal: http://www.sante.gouv.sn/ click ‐les directions‐ and then ‐La Directionde la Pharmacie et des Laboratoires (DPL)‐38.Seychelles: no website identified39.Sierra Leone: website does not exist40.South Africa: /41.Swaziland: MRA is being established .sz/home.asp?pid=9942.Togo: no website identified43.Uganda: http://www.nda.or.ug/44.United Republic of Tanzania: http://www.tfda.or.tz/45.Zambia: no website identified46.Zimbabwe: http://www.mcaz.co.zw/AMRO ‐ Regional Office for the Americas1.Antigua and Barbuda: no website identified2.Argentina: .ar/3.Bahamas: /hospitals_overview_bnda.php4.Barbados: no website identified5.Belize: no website identified6.Bolivia: .bo/snis/enlaces_salud/dinamed/index.htm7.Brazil: .br/eng/index.htm8.Canada: http://www.hc‐sc.gc.ca/dhp‐mps/index‐eng.php9.Chile: http://www.ispch.cl/10.Colombia: .co/11.Costa Rica: http://www.ministeriodesalud.go.cr/ MoH department withinformation on site12.Cuba: http://www.cecmed.sld.cu/13.Dominica: no website identified14.Dominican Republic: .do/15.Ecuador: no website identified16.El Salvador: no website identified17.Grenada: no website identified18.Guatemala:http://portal.mspas.gob.gt/regulacion_y_control_de_productos_farmaceuticos _y_afines.html MoH department with information on site19.Guyana: MoH department.gy/prg_adm_food_drugs.php20.Haiti: website does not exist21.Honduras: http://www.dgrs.gob.hn/22.Jamaica: / pharmacies and pharmacists, not medicines23.Mexico: http://www.cofepris.gob.mx/24.Nicaragua: no website identified25.Panama: http://www.minsa.gob.pa/ MoH department with information onsite26.Paraguay: .py/programas/index.php?id=627.Peru: http://www.digemid.minsa.gob.pe/28.Saint Kitts and Nevis: no website identified29.Saint Lucia: no website identified30.Saint Vincent and the Grenadines: no website identified31.Suriname: no website identified32.Trinidad and Tobago: .tt/sitepages/default.aspx?id=9333.United States of America: /34.Uruguay: http://www.msp.gub.uy/subcategorias_8_1.html35.Venezuela (Bolivarian Republic of): .ve/EMRO ‐ Regional Office for the Eastern Mediterranean1.Afghanistan: website does not exist ‐ only MoH2.Bahrain: no website identified3.Djibouti: no website identified4.Egypt: .eg/5.Iran (Islamic Republic of): no website identified6.Iraq: no website identified7.Jordan: http://www.jfda.jo/en/default/8.Kuwait: no website identified9.Lebanon: .lb/en/Drugs/DrugsListWithLinks.htm10.Libyan Arab Jamahiriya: no website identified11.Morocco: .ma/Medicaments/Pages/default.aspx12.Oman: .om/nv_menu.php?fNm=pharma/regulation.htm13.Pakistan: .pk/14.Qatar: .qa/moh/ under construction15.Saudi Arabia: .sa/En/Home/default.htm16.Somalia: no website identified17.Sudan: .sd/18.Syrian Arab Republic: no website identified19.Tunisia: http://www.dpm.tn/20.United Arab Emirates: .ae/en/Page_431.aspx21.Yemen: http://www.sbd‐/EURO ‐ Regional Office for Europe1.Albania: .al/2.Andorra: http://www.salutibenestar.ad/ MoH department with informationon site3.Armenia: http://www.pharm.am/index.php?langid=24.Austria: http://www.ages.at/ages/ueber‐uns/english‐what‐is‐ages/5.Azerbaijan: http://www.pharm.az/ under construction6.Belarus: http://www.rceth.by/7.Belgium: http://www.fagg‐afmps.be/8.Bosnia and Herzegovina: .ba/9.Bulgaria: http://www.bda.bg/10.Croatia: http://www.almp.hr/?ln=en&w=o_agenciji11.Cyprus:.cy/moh/phs/phs.nsf/dmlindex_en/dmlindex_en?opend ocument12.Czech Republic http://www.sukl.cz/13.Denmark: http://www.dkma.dk/14.EMEA: http://www.emea.europa.eu/ (also: DG Enterprise)15.Estonia: http://www.sam.ee/16.Finland: http://www.nam.fi/17.France: http://www.afssaps.fr/18.Georgia: /02/gdna/home/0,2803,132319894,00.html19.Germany: http://www.bfarm.de/gb_ver/ and: http://www.zlg.nrw.de/ andhttp://www.pei.de/EN/home/node‐en.html?__nnn=true20.Greece: http://www.eof.gr/web/guest/home21.Hungary: http://www.ogyi.hu/main_page/22.Iceland: http://www.imca.is/23.Ireland: http://www.imb.ie/24.Israel: .il/ MoH department with information on site25.Italy: .it/ andhttp://www.agenziafarmaco.it/section8983.html26.Kazakhstan: http://www.dari.kz/?lang=rus27.Kyrgyzstan: http://pharm.med.kg/tvia: .lv/index.php?setlang=en&large29.Lithuania: http://www.vvkt.lt/index.php?332772390330.Luxembourg: http://www.ms.public.lu/fr/activites/pharmacie‐medicament/index.html MoH department with information on site31.Malta: .mt/32.Monaco: no website identified33.Montenegro: /ulms/herlands: http://www.cbg‐meb.nl/35.Norway:http://www.legemiddelverket.no/templates/InterPage____16645.aspx?filterBy =CopyToGeneral36.Poland: .pl/37.Portugal: http://www.infarmed.pt/38.Republic of Moldova: http://www.amed.md/index_eng.html39.Romania:http://www.anm.ro/en/home.html40.Russian Federation: http://www.roszdravnadzor.ru/41.San Marino: no website identified42.Serbia: .rs/43.Slovakia: http://www.sukl.sk/en44.Slovenia: http://www.jazmp.si/index.php?id=5645.Spain: http://www.agemed.es/en/actividad/sgInspeccion/home.htm46.Sweden: kemedelsverket.se/english/47.Switzerland: http://www.swissmedic.ch/index.html?lang=en48.Tajikistan: under constructionhttp://health.tj/en/index.php?option=com_content&task=view&id=6&Itemid=749.The former Yugoslav Republic of Macedonia: no website identified50.Turkey: .tr/51.Turkmenistan: no website identifiedraine: http://www.pharma‐center.kiev.ua/view/en/index53.United Kingdom: /index.htm54.Uzbekistan: no website identifiedSEARO ‐ Regional Office for South‐East Asia1.Bangladesh: /2.Bhutan: .bt/dra.php3.DPR Korea: no website identified4.Democratic Republic of Timor Leste: website does not exist5.India: http://cdsco.nic.in/6.Indonesia: http://www.pom.go.id/e_default.asp7.Maldives: .mv/web/8.Myanmar: no website identified9.Nepal: .np/req_modern_medicine.php10.Sri Lanka: http://203.94.76.60/DRA/home.htm11.Thailand: http://www.fda.moph.go.th/eng/index.stmWPRO ‐ Regional Office for the Western Pacific1.Australia: .au/2.Brunei Darussalam:.bn/pharmacyservices/drugregistration.htm3.Cambodia: no website ‐ only MoH4.China: /a.China, Hong Kong Special Administrative Region:.hk/eps/index.jspb.China, Province of Taiwan: .tw/en/index.aspx5.Cook Islands: no website identified6.Fiji: .fj/FPS/insRA.html7.Japan: http://www.pmda.go.jp/english/index.html8.Kiribati: no website identifiedoʹs Peopleʹs Democratic Republic: no website identified10.Malaysia: .my/.my/index.cfm11.Marshall Islands: no website identified12.Micronesia, Federated States of: no website identified13.Mongolia: http://www.moh.mn/ MoH, .mn/ statespecialized inspection agency, .mn/ Department ofHealth14.Nauru: no website identified15.New Zealand: /16.Niue: no website identified17.Palau: no website identified18.Papua New Guinea: website does not exist19.Philippines: .ph20.Republic of Korea: http://ezdrug.kfda.go.kr/21.Samoa: no website identified22.Singapore: .sg/publish/hsaportal/en/home.html23.Solomon Islands: no website identified24.Tonga: no website identified25.Tuvalu: no website identified26.Vanuatu: no website identified27.Vietnam: .vn/Methodology of identifying websitesThe MRA websites were identified through the following means:-the list of 53 websites available from the WHO study of 2001;-available lists of MRAʹs in Europe(http://www.emea.europa.eu/Inspections/Links.html), Africa(/html/direction_de_la_pharmacie_et_d.html) and theAmericas (/directAutorid/home.htm);-an Internet search on (country name) plus DRA / drug authority / autoridad de medicamentos / autorité des medicaments, ministry of health / ministèrede santé / ministerio de salud / saude;-contacting the National Programme Officers (NPOʹs) and WHO Regional Offices of the Essential Medicines and Pharmaceutical Policies department(EMP).Links that were not working and websites that only mentioned the name of a MRA were not listed as MRA websites (links in black).The existence or nonexistence of websites could not be confirmed for some countries. No website identified means that through the above search methodology, no website was found. Website does not exist means that National Programme Officers have confirmed that there is no website.Acronyms:MoH = Ministry of HealthMRA = Medicines Regulatory Authority。
越南卫生部药品注册规定0416
越南药品注册规定（越南卫生部第3121/2001/QD-BYT号决定）为便于对药品的生产和流通实施统一的国家管理，保障药品的安全、有效和质量可控性，越南卫生部（MOH）决定颁布关于人用防病、治病、补养药品注册的规定（简称为《药品注册规定》）。
解读：越南的药品注册归口越南卫生部管理。
总则第一条在越南生产和流通的人用防病、治病、补养药品必须进行注册并由卫生部给予注册编号。
在特殊场合下（用于防疫、抗灾的药品及孤儿药），卫生部将依据实际情况允许流通未给予注册编号的药品。
解读：各类药品均须注册，由卫生部颁给注册编号，类似于我国的批准文号。
非常情况下，没有注册编号的药品亦可流通。
第二条调整范围及适用对象2.1 调整范围－——国内外具备生产条件的药品生产企业生产的药品在越南上市前均必须注册。
－——科研院所研制的新药，在待技术转让期间，若本单位充分具备生产条件，可申请注册在本单位内生产销售。
解读：与我国不同，具备生产条件的科研院所研制成功的新药在转让前可以生产。
－——授权生产（under-license）的药品只能在越境内符合药品生产质量管理规范（GMP）的药品生产企业进行生产。
解读：貌似我国的委托生产。
－——医疗机构依照诊治病处方配制/生产的服务于本单位诊治疾病的药品,不能在市场上流通.医疗机构的领导必须对药品的配方、生产规程、质量标准及药品的安全有效性负责。
解读：貌似我国的院内制剂，医院领导负责制。
2.2 适用对象以下各单位可以进行药品注册，在越南进行药品生产和流通：－——越南国内各药品生产企业；－——从事药品贸易的国内企业，获准在药品领域内活动的外国公司。
解读：越南国内的药品生产和经营企业，以及有权限的外国公司均可申请药品注册。
这里没有提及科研院所，但从前面条款中不难看出，科研院所、医院等是可以注册药品的。
第三条在本规定内，一些术语做如下理解：3.1 药品是指用于人防病、治病、减轻病情、诊断疾病或调整机体生理职能的产品。
缅甸药品注册原文 Drug Registration(中文)
缅甸药品注册原文Drug Registration（中文）获得缅甸FDA药品注册证的程序Ⅰ按FDA的每项指导准备注册文件A.1. 注册申请包括每种剂型和每种规格A.2. 每种剂量的不同包装不需注册，但在注册文件、形式声明（附件VI）、药物信息摘要（附件VI I）、稳定性报告（9-f项）、包装（10-f项）以及注册表(1)必须要声明“通常使用其中一种包装形式”，必须准备和提供稳定性数据、包装的质检报告（10-g）和包装样品（供留样）A.4. 建议文件用A4纸提交。
.A.5. FDA接受标签为印刷的品样品（复方按USP或BP标准，FDA不接受IP标准）。
A.6. 每个每个规格/剂型注册费为US$ 300（注册评估费US$ 100，注册费US$ 200）。
A.7. 药物注册证的有效期为5年A.8. （管理文件—第1项）应包括授权书（药品拥有者）的样本书。
A.9.（管理文件–第3项）药物产品的原始证书（CPP）准备附件V所列的证书（打印“-------出口许可”和“缅甸进口许可”），并向出口国FDA提交相同资料。
由FDA领导/理事/副理事或国家药物控制和许可机构在每一页签名、盖章。
这些证书装入申报文件。
A.10. （管理文件-第4项）GMP证书和生产许可证在上述证书包括批准药物表的附表的复印件上说明“由原件查证”，并且由药品出口国FDA领导/理事/副理事或国家药物控制和许可机构在每一页签名、盖章（包括签名的国家和日期）A.11. （药物文件—第6项(a和b)原料药的质量控制）按以下形式完成：a.GLP 手册、标准操作规程及质控部门的功能。
b.复方中每一组分的详细说明。
A.13. （药学资料—第9项(e) 分析报告复印件）当样品为临床试验用，必须提供样品的原始检验分析报告（应有质检负责人签名）。
A.14 （药学资料—第9项(f) 每个包装形式的稳定性试验报告）同时申报的细节有“泡罩式”和“塑料瓶”，则必须提供每种包装方式的稳定性数据。
Regulations on drug registration in Vietnam
REGULATION ON DRUG REGISTRATION(Issued in conjunction with decision No3121/2001/QD-BYT dated 18 July 2001of the Minister of Health)Chapter 1 General provisionsChapter II Application dossiers for registration of domestic drug products Chapter III Application dossiers for registration of imported drug products Chapter IV Application dossiers for registration of drug products manufactured under-licenseChapter V Requirements on utilization of drug products for assessment of safety and efficacy on Vietnamese human subjectsChapter VI Infringement settlementChapter VII Regulation enforcementWith the aim to unify the government’s management over production and sale of drugs; to ensure the safety, efficacy and quality of drugs, the MOH hereby promulgates the Regulation on Drug Registration.Chapter 1GENERAL PROVISIONSArticle 1:Drug products produced and sold in Vietnam for purposes of prevention and treatment of diseases and for improvement of the human’s health shall be registered with the Ministry of Health and be approved by the latter to get a registration number. In special cases (drugs for epidemic and disasters relief and orphan drugs) the sale and consumption of un-registered drugs shall be specifically considered and approved by the Ministry of Health.Article 2: Scope of application and objects of the Regulation:2.1. Scope of application:-Drug products produced by legal domestic and foreign manufacturers who have satisfied conditions in drug production, shall the registered before production and sale;-New drug products developed by scientific research institutions, while awaiting technological transferring to any producers with satisfied conditions in drug production, the innovator institutions can apply for registration for their own production and sale, provided that the institutions meet required conditions for drug production.-Drug products produced under-licence can only be produced by a drug producer with GMP standard production facilities located in Vietnam.-Drug products produced and prepared by health care institutions for the use of that institutions or their peripheral stations in therapy (that shall not be sold to the market); Heads of such institutions shall be responsible for drug formula, preparing process, specifications, safety and efficacy of the drugs produced by their institutions.2.2 Scope of application:The following entities can register drug products for production and sale in Vietnam:-Drug manufactures located in the territory of Vietnam;-Domestic companies having functions in pharmaceutical trading, foreign companies registered to operate in pharmaceutical field in Vietnam;Article 3: In this Regulation, some terms can be interpreted as follows:3.1. Drugs are products intended for use in human for the purposes of prevention, treatment, relief or diagnosis of diseases or for modification of physiological functions.3.2. Finished drug products are those drug products that have passed all stages of production and are ready for marketing, distribution and use;3.3. Starting materials are substances, active (active ingredients) or in-active (reagents, excipients), that are put in compositions of drug products in production process.3.4. Western drug products include:-pharmaco-chemicals and biologicals used as starting materials for drug production.- Finished pharmaco-chemical and biological products.3.5. Ancient medicines are those that are used following ancient (old) literatures regarding: number of medicinal ingredients, quantity of each ingredient, processing methods, dosage, usage methods and indications.those that are new combination of known active ingredients; or those knownadministration routes.3.7. A brand name is a name given by a drug manufacturer for a drug product that are different from the generic names or International Non-proprietary Names (INN) internationally or domestically recognized.3.8. Drug stability is stability of quality of drug products (starting materials or finished products) that, under specified storage conditions, remain their physical, chemical and biological nature, and their characteristics of pharmacology, toxicity, etc. in specified limitations.3.9. Drug shelf-life is the duration from the time point when a drug product is produced to the predicted time point when the drug product still maintains its quality criteria as required in respective specifications in specified storage conditions.3.10. Expiration date is a certain validity period from the date of production given to a certain drug product, within which and under specified storage conditions the product still meets required the registered specifications, and after the date the drug product is no longer valid for use.3.11. A drug product under-licence is a drug product owned by a domestic or a foreign drug entities and has been granted a registration number (in Vietnam or in other countries), the production of which has been authorized by that manufacturer to another legal drug manufacturer in Vietnam.Article 4:An application dossier for registration of a drug product shall be prepared in three sets, including at least one of originals. In the applicationdossier, the followings papers shall be provided with the originals or notarized papers:-Free Sale Certificate (FSC)-Certificate of Good Manufacturing Practices (GMP Certificate)(The FSC and GMP can be replaced with a Certificate of Pharmaceutical Product (CPP)).In addition, two sets of drug labeling shall be attached to the application dossier. The application dossier shall be literally presented on A4-sized paper sheets, in required order, with clear separation between different parts.All the documentation in the dossier shall be certified by manufacturer (with signature and stamp). In case where drug labeling is glued on A4-sized paper sheet, adjoint stamp is required.-Application dossiers of drug manufacturers located on the territory of Vietnam shall be presented in Vietnamese language.Application dossiers of imported drug products shall be presented in Vietnamese language or English. The Summary of Product Characteristics shall be written in Vietnamese language.Name of ingredients of the drug product shall be stated by generic names or international or domestic non-proprietary names. For the ingredients of herbal origin, the names shall be given along with scientific names in Latin.-For a domestic drug products applied with a brand name, the application dossier shall be included a copy of a reference note proving that no similar names have been registered with the Department of Industrial Properties Protection (Ministry of Science, Technology and Environment) or a certificate of industrial properties registration issued by the Department.For imported drug products with marketing authorization in the country of manufacture, reference to the trademark and design by the Department mentioned in the previous paragraph must be made upon request.- A local applicant applying for registration of a drug product as a new drug manufacturer shall provide the following papers:＋Certificate of operation registration with indication of business functions＋ Certificate of Good Manufacturing Practices or Certificate of satisfied conditions for manufacturer of medicinal plants or herbal medicines (applied to drug products originated from medicinal plants only).Article 5: Labeling requirements:-Drug labeling shall comply with the Circular on Drug Labeling issued by the MOH and the Regulation on Goods Labeling issued in conjunction with the Decision No: 178/1999/QD-TTg dated 30 August 1999 of the Prime Minister. -Brand-names, principal trademark (language, images or combination of them which is presented with one or more colours) shall not imitate or be confusingly similar to the names or principal trademarks of drug products of other manufacturers that have already been approved by MOH; not infringe to industrial properties rights; not be confusing to the nature of drug product or being exaggerated in presentation and ambiguous to the potency of drug products. The use of generic names or international or national non-propriety names for drug products are encouraged.-Other information, such as bar code, digital code, medals, awards, marks of industrial properties rights to be appeared on the label, should be provided with proper duly proof.-Labels that are officially marketed shall be of the same colour and presentation as those provided in the application dossiers for drug registration.Article 6:In the period of registration validity, a registered drug product shall be applied for registration as a new application if any of the following changes is made:-change of formula and compositions;-change of pharmaceutical dosage form;-change of quality specifications and analytical methods;-change of route of administration;-change of manufacturing process and methods;-change of manufacturer.Article 7:In the period of registration validity, the following changes to a registered drug product shall be subject to prior approval of MOH:- product name;- dosage;- labeling;- applicant;-manufacturer (provided that the site of manufacturer remains unchanged); -shape or colour of product, provided that the changes will not impose any impact to quality specifications and analytical methods of the product;-change or for more indications;-change or for more contra-indications;-site of manufacturer (provided that the manufacturer remains unchanged); - drug shelf-life;-presentation of product label;-change or for more packing sizesApplication dossiers for the any of changes or additions specified in this Article shall include the following:-forms 1-DKT and 9A-DKT (for domestic drug products) or 9B-DKT (for imported drug product), or 9C-DKT for change of applicant (01 original copy)-documents related to the proposed changes or additions (01 original copy) For imported drug products, in applying for change of product name, the Free Sale Certificate in the country of manufacture for the product under new name must be submitted; applying for change of the site of factory, a GMP certificate for the factory at new location must be submitted; applying for change of name of manufacturer, a GMP certificate issued to the manufacturer under the new name. The aforesaid certificates (FSC, GMP) must be issued bythe national competent authority in the country of manufacture.Article 8:-The registration is valid for 5 years from the date of issuance. The Ministry of Health shall have specific guidance to specific cases. The registration number given shall be printed on the drug label.-Six months prior to the expiry of the registration, for continuation of production and marketing of the drug product in Vietnam, the registration applicant shall apply for the re-registration. Applications for re-registration shall only be acceptable if being submitted not later than 6 months after the registration expiry. Submissions for re-registration that are made later than 6 months after the registration expiry follow requirements as new applications. -Application dossiers for re-registration is specified in Article 15, Chapter II, (for domestic drug products), Article 19, Chapter III (for imported drug products), Article 22, Chapter IV (for drug products under-licence) of this Regulation.Article 9: Requirements on stability studies and registration of shelf-life:9.1. Stability of drug product:-All drug products shall be stored in such storage conditions as required by the manufactures that are given based on stability studies;-Reports of stability studies shall specifically indicates: conditions for storage of product sample (temperature, humidity, etc), package, methods of study, results of studies in all indicators conducted on at least three different batches, a conclusion of stability of the studied drug product.-Results of accelerated stability studies shall only be valid for prediction of drug shelf-life for new application for registration. For products under-licence: if report of normal stability studies conducted on the batches produced in Vietnam is not available, reports of stability studies conducted by the foreign licence holder can be used for registration purpose. During port-marketing period, the manufacturer shall monitor the stability of the drug product in normal conditions confirm the predicted product stability.Reports of normal stability studies shall be submitted as part of application dossier for re-registration.-For imported drug products that have been marketed for a period equivalent to or longer than the predicted shelf-life, report of normal stability studies shall be submitted as part of application for registration in Vietnam.9.2. Shelf-life of drug product:-The product shelf-life shall be established basing on proper stability studies.The shelf-life of a drug product shall not be longer than the shelf-life obtained in stability studies.-Heads of applicant companies shall be responsible for the quality of drug products during the period of registered shelf-life.Article 10:Domestic registration applicants shall submit applications to its direct managing authorities (provincial departments of health, department of health of other ministries) for certification of legal status and manufacturing conditions with their opinions as request for registration approval of the Ministry of Health (with exception for the drug products included in Appendix 1). The direct managing authorities shall have their certification and opinions on the application of the applicants not later than 7 days from the date of receipt of proper application. The applications shall the then be submitted to the Ministry of Health for assessment and registration.Application dossiers of the members of VINAPHARM, of 100% foreign-invested manufacturers shall be signed and stamped by director of the manufacturers and then submitted to the Ministry of Health (with exception for the drug products included in Appendix 1).The MOH shall, after receiving a complete application dossier, have feedback to the applicant in 3 months for domestic drug product, and 12 months for foreign drug product at maximum.For the drug products included in the Appendix 1, the application dossiers shall be submitted to the provincial department of health of therespective province where the production takes place for assessment. Those applications that have passed assessment of the provincial department of health shall be listed (with accurate product names and compositions) and sent as an attachment to an official request to the Ministry of Health for approval and registration grant.Registration applicants after having drug product registered, shall be obliged to send the quality specifications of their registered products to the National Institute of Drug Quality control, the Sub-institute of Drug Quality Control and provincial drug quality control centers.Article 11:Registration applicants shall pay a fee as required by current regulations.Chapter II Application Dossiers for Registration of Domestic Drug ProductsArticle 12:12.1. Application dossier for registration of a medicinal starting material shall contain:-Cover page (form 1- DKT)-List of contents (form 2- DKT)-Application (form 3- DKT)-Manufacturing process (fully detailed)-Quality specifications and analytical methods (fully detailed )-Certificate of analysis of the samples submitted for registration: must be released by either of the following institutions: National Institute or Sub-institute of Drug Quality Control or by the manufacturer of GMP standard; GLP standard Laboratories.-Report of stability studies of the material;-Labeling samples (as designed or attached to Form 7- DKT);-Samples: 1 sachets (sufficient for three analysis).12.2. Application dossier for registration of a domestic new medicinal starting material shall contain, in addition to those required in 12.1 of this Article, the following:-study report on toxicology;-study report on experimental pharmacology-study report on clinical pharmacologyArticle 13:13.1. Application dossiers for registration of western drug product shall contain: -Covering page (from 1- DKT)-List of contents (from 2-DKT)-Application (from 4- DKT)-Summary of product characteristics (form 6- DKT);-Manufacturing process (fully detailed);-Quality specifications and analytical methods (fully detailed);-Certificate of analysis of the samples submitted for registration: must be released by either of the following institutions: National Institute or Sub-institute of Drug Quality Control or by the manufacturer of GMP standard; GLP standard Laboratories.-Reports of stability studies;-Labeling samples: (as designed or attached to Form 7- DKT);-Product samples: 1 packing units of the packing sizes applied for registration.13.2. Application dossiers for a new western drug product shall contain, in addition to those required in 13.1 of this Article, the following:-Study report on toxicology (acute toxicity, sub-chronic toxicity, chronic toxicity, molecular toxicity, etc.);-Study report on experimental pharmacology;-Study report on pharmacokinetics and bio-availability;-Study report on clinical pharmacology；-Minute of meeting of appropriate ministerial scientific committee forArticle 14:14.1. Application dossiers for registration of ancient medicines originated from medicinal plants, medicines originated from medicinal plants with known indications, the medicines that have been registered with the Ministry of Health, shall contain:-Cover page (form 1- DKT)-List of contents (from 2- DKT)-Application (form 4A-DKT)-Summary of product characteristics (Form 6);-Manufacturing process (fully detailed);- Quality specifications and analytical methods;-Certificate of analysis of the samples submitted for registration must be released by either of the following institutions: National Institute or Sub-institute of Drug Quality Control or by the manufacturer of GMP standard; GLP standard Laboratories.-Report of stability studies;-Literature documents demonstrating the origin of the formula;-Labeling samples: (as designed or attached to Form 7- DKT);-Product samples: 1 packing units of the packing sizes applied for registration.14.2. Application dossiers for registrations of a medicine originated from medicinal plants that that are not ancient, medicines originated from medicinal plants that are popularly used but proposed for new inknown indications, shall contain, in addition to those required in 14.1 of this Article, the following:-Report of studies on the safety and efficacy of the medicine of medicinal plants origin (conducted in compliance with the current regulations of the MOH)-Minute of meeting of a relevant ministerial scientific committee or institutional scientific committee (for MOH research institutions) forArticle 15: Application dossiers for re-registration of domestic drug products shall contain:-Cover page (form 1- DKT)-List of contents (form 2-DKT)-Application (form 5A-DKT)-Summary of product characteristics (Form 6- DKT);-Labeling samples: in compliance with the current regulation on drug labeling of the MOH (as designed or attached to Form 7- DKT);-Report of post-marketing monitoring-Product samples: 1 packing units of the packing sizes applied for registration.Chapter III Application Dossiers for Registration of Imported Drug ProductsArticle 16:16.1. Application dossiers for registration of imported medicinal starting materials shall contain:-Cover page (from 1- DKT)-List of contents (form 2- DKT)-Application (from 3B-DKT)-Summary of product characteristics (form 6- DKT);- A Free Sale Certificate in the country of origin issued by the competent authority of the country of origin (FSC Certificate ):-GMP certificate issued by the competent authority of the country of origin;-Manufacturing process (fully detailed)-Quality specifications and analytical methods (fully detailed);-Certificate of analysis released by the manufacturer;-Report of stability studies;-Labeling samples: (as designed or attached to Form 7- DKT);-Samples of the starting material: 1 sachets (sufficient for three analysis). 16.2. Application dossier for registration of a new medicinal starting material shall contain, in addition to those required in 16.1 of this Article, the following:-study report on toxicology;-study report on experimental pharmacology;-study report on clinical pharmacologyArticle 17:17.1. Application dossiers for registration of imported western drug products shall contain:-Cover page (form 1- DKT)-List of contents (form 2-DKT)-Application (form 4B-DKT)-Summary of product characteristics (form 6- DKT);-Free Sale Certificate in the country of origin issued by the competent authority of the country of origin;-GMP certificate issued by the competent authority of the country of origin;-Manufacturing process (fully detailed)-Quality specifications and analytical methods (fully detailed);-Certificate of analysis released by the manufacturer;-Report of stability studies;-Labeling samples: (as designed or attached to Form 7- DKT);-Product samples: 1 packing units of the packing sizes applied for registration.17.2. Application dossiers for registration of new western drug products shall contain, in addition to those required in 17.1 of this Article, the following:-Study report on toxicology (acute, sub-chronic, chronic and molecular toxicity);-Study report on experimental pharmacology;-Study report on pharmacokinetics and bio-availability;-Study report on clinical pharmacology.Article 18:18.1. Application dossier for drug products containing ingredients originated from medicinal plants that have been popularly used and with know indications in Vietnam, shall contain:-Cover page (form 1- DKT)-List of contents (form 2- DKT)-Application (form 4B-DKT)-Summary of product characteristics (from 6- DKT);-Free Sale Certificate in the country of origin issued by the competent authority of the country of origin;-GMP certificate issued by the competent authority of the country of origin;-Manufacturing process (fully detailed)-Quality specifications and analytical methods (fully detailed);-Certificate of analysis released by the manufacturer;-Report of stability studies;-Labeling samples: (as designed or attached to Form 7-DKT);-Product samples: 1 packing units of the packing sizes applied for registration.18.2. Application dossier for registration of drug products containing ingredients originated from medicinal plants that have been used in Vietnam, but with new indications, or drug products containing ingredients from medicinal plants that have not been used, in addition to those required in 18.1 of this Article, shall contain:-Report of studies on the safety and efficacy of the drug products with ingredient originated from the medicinal plants (conducted in compliance with the current regulations the country of origin or as recommended by WHO)Article 19: Application dossiers for re-registration of imported drug products shall contain:-Cover page (form 1- DKT)-List of contents (from 2- DKT)-Application (from 5B- DKT)-Summary of product characteristics (from 6- DKT);-Labeling samples: (as designed or attached to Form 7- DKT);-Free Sale Certificate in the country of origin issued by the competent authority of the country of origin;-GMP certificate issued by the competent authority of the country of origin;-Report on post- marketing monitoring (from 8B-DKT)-Product samples: 1 packing units of the packing sizes applied for registration.For a drug product that is manufactured by one manufacturer and packaged by another manufacturer, the following shall be added:-GMP certificate of the manufacturer of the bulk drug;-GMP certificate of the packager; and-Free Sale Certificate issued by the competed authority of the country of manufacture or packager.Chapter IV Application Dossiers for Registration of Drug Products Manufactured Under-licenceArticle 20: Application dossiers for registration of drug products manufactured by a domestic manufacturer under-the-licence of another domestic manufacturer shall contain:-Cover page (form 1- DKT).-List of contents (form 2- DKT).-Application for manufacture of drug products under-licence (from 4C-DKT). -Summary of product characteristics (form 6-DKT);-Contract of manufacture under-licence;-Product licence of the drug product to be manufactured under-licence.-GMP certificate of the facility where under-licence manufacture takes place; - Quality specifications and analysis methods: established by the productlicence holder;-Certificate of analysis released by the under-licence manufacturer;-Manufacturing process established by the product licence holder;-Report of stability studies;-Labeling samples; (as designed or attached to From 7-DKT);-Product samples: 1 packing units as the one applied for circulation.Article 21: Application dossiers for registration of a drug product manufactured by a domestic manufacturer under-the-licence of a foreign company shall contain:-Cover page (form 1- DKT)；-List of contents (form 2- DKT)；-Application form under-licence-manufacture of drug products (from 4C-DKT)；-Summary of product characteristics (from 6-DKT);-Free Sale Certificate of the product to be manufactured under-licence issued by the competent authority of the country of origin;-GMP certificate issued by the competent authority of the country of origin for the product licence holder;-GMP certificate issued by the competent authority for the under-licence-manufacturer;-Contract of under-licence manufacture between licence holder and the under-licence manufacturer;-Manufacturing process established by the product licence holder;- Quality specifications and analysis methods established by the product licence holder;-Certificate of analysis released by the under-licence manufacturer;-Report of stability studies;-Labeling samples: (as designed or attached to Form 7-DKT);-Product samples: 1 packing units as the one applied for circulation.Article 22: Application dossiers for re-registration of drug productsmanufactured under-licence shall contain:-Cover page (Form 1- DKT);-List of contents (Form 2- DKT);-Application (Form 5C-DKT);-Summary of product characteristics (Form 6-DKT);-Labeling samples: (as designed or attached to Form 7- DKT);-Report of post-marketing monitoring (Form 8-DKT);-Product sample: 1 packing unit as the applied for circulationChapter V Requirements on Utilization of Drug Products for Assessment of Safety and Efficacy on Vietnamese Human SubjectsArticle 23:The drug products may not innovated drug products, when appropriate and necessary, shall be tried to assess the product efficacy with the purposes to verify the effects, indications, contra-indications, dosage, toxicity, side-effects and the safety of that products for the use on Vietnamese population.The medical institutions where such an assessment would take place, shall prepare an application and obtain a written permit of the MOH prior to introduction of the product to trial in that institution.Article 24Medical institutions where drug products can be tried for assessment shall include such institutions as: hospitals and institutions with patient beds where technical equipment and facilities and qualified professionals are available for carrying out different stages of trials and to solve the possible implications. The sponsors shall be drug manufacturers or a drug registration applicants. Drug sponsors and the medical institution shall be fully responsible for the quality and safety matters throughout the trial.Article 25:Application for assessment of drug products on human subjects shall be submitted in three sets, including at least one of original or notarized copies.。
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DRUG @ REGISTRATION.VN REGISTRATION.VN provides customer from small packages to full services of the overall process in flow chart as follows
FOOD SUPPLEMENT @ REGISTRATION.VN Consultant, preparing proclamation dossiers for food Supplement products Make full dossier for food Supplement products On behalf of the customer, we submit dossier at Food Administration Office and get the result Consult, choose selection-optimal solutions when arising problems during evaluating dossier Acting as “legal representative” for foreign companies without business license in Vietnam MEDICAL DEVICE @ REGISTRATION.VN Submit registration dossiers for product circulation in the Department of Medical Device & Health works (VMoH); and other state managing departments COSMETIC @ REGISTRATION.VN Submit quality specification proclamation dossier at Drug Administration – Vietnamese Ministry of Health for imports Submit quality specification proclamation dossier at local health office for domestic products
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REGISTRATION.VN is a trust partner for taking all activities relating to your registration of drug, company license for pharmaceutical business, medical devices, functional food, cosmetic… in Vietnam REGISTRATION.VN always stands by customers to achieve the goals with three criteria: * Fast response * Saving money * Professional service REGISTRATION.VN has been co-operated and supported many customers from France, Ukraine, Lithuania, Poland, South Korea… to proceed registration procedures in accordance with new regulations (ACTD…) of Vietnamese Mints with REGISTRATION.VN
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