药品申请注册所需材料英文版Declaration materials
Declaration materials
Part1: Overview materials
1. Name of the medicines
2. Profiles of proof
3. Purpose and evidence of the proposal
4. Summary and review of main research results
5. Medicine directions, draft instructions and related references
6. Design drafts of the package and logo.
Part2: Pharmaceutical research materials
7.Overview of pharmaceutical research
8.Research and reference materials of API manufacturing process; Research and reference materials of prescriptions and manufacturing process of preparations.
9.Experimental materials and references of confirming medicine chemical structure or components
10.Experimental materials and references of quality research
11.Pharmaceutical standards and draft instructions with standard products or control samples
12.Analytical report of samples
13.The source, quality standard and analytical reports of API and adjuvants
14.Experimental materials and references of medicine stability research
15.Selection criteria and quality standards of packing materials and containers which directly contact the medicine
Part3: Pharmacological and toxicological research materials
16.Overview of pharmacological and toxicological research materials
17.Main pharmacodynamic experimental materials and references
18.General pharmacological experimental materials and references
19.Acute toxicity experimental materials and references
20.Long-term experimental materials and references
21.Allergic (partial, systemic and photosensitive toxicity), hemolytic and partial stimulation (blood vessels, skin, mucosa and muscles, etc.) and other special safety experimental materials and references
22.Experimental materials and references of interactions of multi-components’ properties, toxicity and pharmacokinetics in compound preparation
23.Mutagenic experimental materials and references
24.Reproductive toxicity experimental materials and references
25.Carcinogenic experimental materials and references
26.Dependence experimental materials and references
27.Non-clinical pharmacokinetic experimental materials and references
Part4: Clinical experimental materials
28.Overview of domestic and overseas relating clinical experimental materials
29.Clinical test plan and research scheme
30.Clinical researchers’ manual
31.ICF sample manuscript, Ethics committee’s approval
32.Clinical test reports
PS: Part 2 (Pharmaceutical research materials) is supposed to be sorted according to module 3, CTD. Specific requests of CFDA are consistent with that of FDA. Some details need to be discussed specifically and CFDA may have more requests than FDA does.。
药品再注册审查管理规程 英文版
药品再注册审查管理规程英文版Drug Re-registration Review and Management Regulations (English Version)Article 1These Regulations are formulated in accordance with the “Regulations on the Administration of Pharmaceutical Products”(hereinafter referred to as the Regulations) and other relevant laws and regulations, in order to regulate the administration of drug re-registration, and to ensure the safety and effectiveness of drug circulation and use.Article 2The National Medical Products Administration (hereinafter referred to as the NMPA) is responsible for the unified management of drug re-registration in the country. The local Medical Products Administration (hereinafter referred to as the LMA) is responsible for the management of drugre-registration in its respective area.Article 3Drug re-registration generally refers to the review and approval of the registration documents of pharmaceutical products that are about to expire, with the purpose of renewing their registration. The scope of drug re-registration shall besubject to the regulations of the registration certificate issued by the NMPA. The applicant shall be the original holder of the registration certificate.Article 4The applicant for the drug re-registration shall submit the following documents to the NMPA for review and approval:1. Drug re-registration application form.2. The original registration certificate and its copy.3. Product quality management documents including product formula, process flow chart, raw materials list, technical requirements, inspection standards, etc.4. Product quality inspection reports.5. Product packaging and label design.6. Other documents required by the NMPA.Article 5The NMPA shall, within 15 working days of receiving the application for drug re-registration, examine the application documents in accordance with the Regulations, and decide whether to approve or reject it.Article 6The applicant shall, within 6 months prior to the expiration of the registration certificate, submit theapplication for drug re-registration to the NMPA. Any application submitted after the expiration of the registration certificate shall not be accepted.Article 7After the NMPA approves the application for drugre-registration, it shall issue a new registration certificate to the original certificate holder. The newly issued registration certificate shall have the same validity period as the original certificate.Article 8For any major changes in the production process, formulation, packaging and labeling, etc., of a product for which a registration certificate has been issued, the holder of the registration certificate shall apply for a change in the registration certificate.Article 9The NMPA may, according to the actual situation of the drug re-registration, carry out spot checks on the applicant’s products and production sites, and entrust third-party organizations to carry out product quality and safety tests. Article 10These Regulations shall come into force on the date ofpromulgation. Any other regulations or local regulations which are inconsistent herewith shall be repealed simultaneously.。
亚美尼亚药品注册要求-英文版
Requirementsto the Registration of Medicinal products in the Republic of ArmeniaYerevan2010Requirements to the Registration of Medicinal products in the Republic of ArmeniaCurrent requirements to the registration are based on the below mentioned legislative acts: The Laws of the Republic of Armenia “On Medicinal product s”, “On State Taxes”, and the Decree of the Government of the Republic of Armenia No 347 of 25 April, 2001 “On adopting the Rule of Registration of Medicinal products and Expertise Fees for Registration of Medicinal products in the Republic of Armenia”, amended by Government Decrees No 148-N of 3 February, 2005 and No 1000-N of 3 September, 2009, the Order No 123-N of the Ministry of Health of the RA dated 7 February, 2006 on approval of …‟T he Procedure of Expertise for Registration of Medicinal products in the Republic of Armenia, Form and Description of the Registration Certificate and the List of variations of medicinal products registered in the Republic of Armenia that do not require new registration.‟‟1. General provisions1.1. It is allowed to import, produce, store, distribute, sell and use only those medicinalproducts on the territory of the Republic of Armenia which are registered in the Republic of Armenia.1.2. Registration of medicinal products, rejection and withdrawal of registration iscarried out by the Ministry of Health of the Republic of Armenia, and of veterinary vaccines, serums and diagnostics - by the Ministry of Agriculture of the Republic of Armenia.1.3. Registration of medicinal products is conducted based on the results of thescientifically justified criteria and expertise of safety, efficacy and quality of medicinal products. Expertise of medicinal products for registration is carried out by the Scientific Centre of Drug and Medical Technology Expertise (hereinafter referred to as …Scientific Center‟1).1.4. Every registration of medicinal products is carried out according to eachmanufacturer (firm), and also each country of origin, if the production of the same medicinal product is carried out in different countries by the same manufacturer.1 Address: 15 N1 Moskovyan street, Yerevan 0001, Armenia, Tel.: +374-10-58-40-20, Fax: +374-10-58-53-35, E-mail: admin@pharm.am, website: www.pharm.am1.5. The quality of medicinal products registered in the Republic of Armenia shallcomply with the requirements of currently used officially Pharmacopoeias in the Republic of Armenia: the XI State Pharmacopoeia of the former USSR, the European Pharmacopoeia(Ph Eur), the International Pharmacopoeia (Ph Int), the American Pharmacopoeia (USP), the British Pharmacopoeia (BP), the German Pharmacopoeia (DAP), the German Homeopathic Pharmacopoeia (HAB), the French Pharmacopoeia (PhF) and in some cases - temporary Pharmacopoeial monographs approved by the Ministry of Health of the Republic of Armenia.1.6. The following is subject to registration in the Republic of Armenia:∙new original and generic medicinal products (including immunological, veterinary, homeopathic),∙additional dosage strengths, pharmaceutical forms and new indications of registered medicinal products,∙new combination of medicinal products.1.7. Registration is not required for medicinal products, which are made in Pharmacies in accordance with Prescriptions and in the cases defined by the Government of the Republic of Armenia.1.8. The period of validity of registration of medicinal products in the Republic of Armeniais five years. At the expiry date of the term of the registration of the medicinal product it is subject to new registration.1.9. In case of changes in the composition, manufacturing technology, internationalnonproprietary names of registered medicinal products, as well as in case of new therapeutic indications, medicinal products are subject to new registration. The Ministry of Health defines the List of variations of medicinal products registered in the Republic of Armenia that do not require new registration (Appendix 2).1.10. In accordance with the order of the Ministry of Health during 30 days after issuingthe Registration certificate the information on registered medicinal product is included in the State Register of Medicinal products of the Republic of Armenia which is published according to the regulation.2. Submission of Application for registration2.1. For the purpose of registration of medicinal products, the manufacturer or itsauthorized representative (hereinafter referred to as …applicant‟) submits a required documentation according to the approved lists (Appendix 1.1-1.9), samples of medicinal products and reference standards to the Scientific Centre. Documents are submitted in Armenian, Russian or English and also on CD, if available.2.2. The applicant is responsible for the authenticity of documents and correctness of information.2.3. Applicant shall submit samples of medicinal products in Armenian, or in Russian, orin English (for prescription medicinal products) packaging and labeling: two consumer packages (checking-identification and laboratory-arbitrage) and in necessary quantities (in consumer packages) required for laboratory expertise complied with the specifications and methods of analyses (pharmacopoeial monographs, etc.)3. Registration procedure3.1. Preliminary examination of submitted documentation and samples is carried out bythe Scientific Centre within maximum 10 days about which the applicant receives a written notification with indication of the expertise fee (Appendix 3).3.2. Expertise for registration is started after payment of expertise fee as an advancedpayment. The date of payment is considered as the start point of the expertise.Maximal duration of expertise is 180 days.3.3 The applicant may request for withdrawing the application at any time before theend of the expertise. In this case the submitted documentation, samples and reference standard as well as the expertise fee are not returned to the applicant.3.4 In case of failing to pay the expertise fee within 6 month upon receiving the writtennotification on payment, the applicant has to submit a new application.3.5 The expertise of pharmacological, toxicological, clinical and pre-clinical studies,technological procedures, specifications and methods of analyses, methods of manufacturing and quality control is carried out in terms of assuring the compliance of a medicinal product with the approved requirements of quality, safety, efficacy and manufacturing standards.3.6 If the results of the laboratory expertise of the medicinal product are negative, theapplicant may submit new samples of the medicinal product of two series different from the previous one, in a sufficient quantity to carry out two laboratory testing.3.7 If the information provided for the purpose of evaluating the quality, safety andefficacy of medicinal products is inadequate, the Scientific Centre may request additional documentations, samples and data. The period for providing of the required supplementary documents, samples of medicinal products and information is not included in the expertise period. In case the applicant fails to submit required documentation and/or samples and/or reference standards within 6 months, the expertise is suspended and the application is annulated.3.8 After the expertise the Scientific Centre submits the assessment report to thePharmacological Council of the Ministry of Health within 5 days.3.9 Receiving the results of the expertise, the Pharmacological Council of the Ministry ofHealth provides recommendation about registration or refusal of registration of the medicinal product in the Republic of Armenia, as well as conclusion about including the medicinal products in the lists (Controlled medicinal product, Non-prescription medicinal product, Essential medicinal products) adopted in the Republic of Armenia within 15 days. The notice about the conclusion of the Pharmacological Council of the Ministry of Health should be sent to the applicant within 5 days.3.10 The decision about registration of medicinal product is made by the Ministry ofHealth within 10 days on the base of the expertise results, conclusion of the Pharmacological Council and payment of state tax in accordance with established procedure and amount (Appendix 4) to the appropriate account of the State Treasury of the Republic of Armenia (in case the payment is made in foreign currency –in accordance with the actual at date exchange rate established by the Central Bank of RA).3.11 The registration procedure will be suspended if the state tax is not paid inaccordance with established procedure and amount by the applicant within 30 days after notification about positive conclusion of the Pharmacological Council of the Ministry of Health. In the future the expertise for registration of medicinal product will be conducted due to the established procedure by applying new application.3.12 The registration certificate should be issued to the applicant within 10 calendardays according to the order of the Ministry of Health about registration of the medicinal product.3.13 The manufacturer should inform the Scientific Centre about any changes of theregistered medicinal product by submitting relevant documentation on changes. The submitted documentation (sample) is evaluated within 30 days, and after the approval by the Ministry of Health of the Republic of Armenia is included into the registration documentation. Variations not requiring new registration (Appendix 2) are taken into consideration. In case of changes in the name of the medicinal product, the name of manufacturer or the marketing authorization holder, additional presentation and packaging - the registration certificate is re-formulated by adding number of variation to the number of registration certificate.3.14 Both approved documentation and sample are used as a base for identification,quality control and official information regulation in all stages of regulation in the Republic of Armenia. The sample of a medicinal product includes, immediate and/or outer packaging, labeling, instruction for use as well as color mock-ups.3.15 The results of expertise for registration of medicinal products can be appealedaccording to the legislation of the Republic of Armenia.4. Rejecting the registration of medicinal products and withdrawal.4.1. The registration of medicinal products is rejected if the following is available:∙ a negative conclusion of the expertise.∙alerts on the medicinal product received from international specialized sources∙the medicinal product contains chlorofluorocarbons (CFC), except those medicinal products, which list is approved by the Ministry of Health4.2. The applicant is informed on the rejection of the medicinal product registrationwithin 10 days.4.3. The registration of a medicinal product may be withdrawn and the circulation ofthe medicinal product may be suspended, if the following is available:∙ a notification from the manufacturer,∙non-compliance with the adopted criteria of quality, safety and efficacy of the medicinal products, including new serious adverse reactions,alerts on the medicinal product received from international specialized sources.4.4. The information on withdrawal of the medicinal product registration is provided bythe Ministry of Health in the specialized and official publications within 10 days.4.5. The manufacturer covers the expenses of withdrawing the medicinal product fromregional pharmaceutical market.4.6. Decisions on registration withdrawal of the medicinal product may be appealedaccording to the Legislation of the Republic of Armenia.Appendix 1.1Listof documents required for the registration of generic medicinal productsin the Republic of Armenia1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Certificate of Good Manufacturing Practice (GMP) issued by the authorized body ofthe country of origin (for manufacturers in the Republic of Armenia and CIS countries-manufacturing license if the GMP certificate is not available-either original or verified copy).4. Registration status in other countries.5. Summary of Product Characteristics (Appendix 1.9).6. Instruction for use for specialists and patients.7. Qualitative and quantitative composition of the medicinal product (including excipients).8. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).9. Quality certificates of the active substances and excipients of the medicinal product.10. Summary lot protocol of vaccines and serums and the Lot Release certificate issuedby the NRA of the country of origin.11. Data on stability study and shelf life of medicinal product12. Brief description of the technological process, chemical, technological and equipmentschemes of the production, including controls of critical steps .13. Data on pharmacokinetic and/or bio-equivalence and/or limited clinical trials of themedicinal product. If they are not available, for manufacturers of the Republic of Armenia and CIS countries- data on acute toxicity study.14. Information on pharmacological, toxicological and clinical trials (literature references orown data).15. For veterinary medicinal products - information on maximum residue limits in thefoodstuff (meat, milk, egg, etc.). The time limitation of foodstuff use.16. The label and packaging of the medicinal product and/or its color mock-ups andspecimens (also electronic version) for all presentations mentioned in the application.17. Certificate (verified copy) or verified extract from appropriate register about legalprotection of trademark issued by the Intellectual Property Agency of the Ministry of Economy of the Republic of Armenia18. Periodic Safety Update Report.19. TSE-Certificate of Suitability for the material of animal origin.Appendix 1.2Listof documents required for the expertise of medicinal products containing new active substances for registration in the Republic of Armenia1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Certificate of Good Manufacturing Practice (GMP) issued by the authorized body ofthe country of origin (for manufacturers in the Republic of Armenia and CIS countries-manufacturing license if the GMP certificate is not available-either original or verified copy).4. Registration status in other countries.5. Summary of Product Characteristics (Appendix 1.9).6. Instruction for use for specialists and patients .7. Qualitative and quantitative composition of the medicinal product (including excipients).8. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).9. Quality certificates of the active substances and excipients of the medicinal product.10. Data on stability study and shelf life of medicinal product.11. Brief description of the technological process, chemical, technological and equipmentschemes of production, including control of critical steps.12. Reports on the pre-clinical studies of the of pharmacological activities,pharmacodynamic, pharmacokinetic and adverse reactions of the medicinal product. 13. Reports on the pre-clinical studies of the safety (acute, sub-chronic and chronictoxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, local tolerance, antigenicity, Immono-toxicity and other toxicity studies).14. Reports on the clinical trials on the specific activity, pharmacodynamic,pharmacokinetic and adverse reactions of the medicinal product.15. For veterinary medicinal products - information on maximum residue limits in thefoodstuff (meat, milk, egg, etc.). The time limitation of use of the foodstuff use.16. The label and packaging of the medicinal product and/or its color mock-ups andspecimens (also electronic version) for all presentations mentioned in the application.17. Certificate (verified copy) or verified extract from appropriate register about legalprotection of trademark and/or patent issued by the Intellectual Property Agency of the Ministry of Economy of the Republic of Armenia18. Periodic Safety Update Report.19. TSE-Certificate of Suitability for the material of animal origin.Appendix 1.3Listof documents required for expertise of homeopathic medicinal products forregistrationin the Republic of Armenia1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Certificate of Good Manufacturing Practice (GMP) issued by the authorized body ofthe country of origin (for manufacturers in the Republic of Armenia and CIS countries- manufacturing license if the GMP certificate is not available) (either original or verified copy)4. Registration status in other countries.5. Summary of Product Characteristics (Appendix 1.9).6. Instruction for use of the combined homeopathic medicinal products.7. Qualitative and quantitative composition of the medicinal product (including excipients).8. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).9. Quality certificate of the medicinal product.10. Data on stability study and shelf life of medicinal product.11. Data on the efficacy and safety of the medicinal product.12. The label and packaging of the medicinal product or its color mock-ups andspecimens (also electronic version) for all presentations mentioned in the application .Appendix 1.4Listof documents required for the registration expertise of the medicinal product registered in the Republic of Armenia and produced in other countries by the samemanufacturer1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Summary of Product Characteristics (Appendix 1.9).4. Instruction for use for specialists and patients.5. Certificate of Good Manufacturing Practice (GMP) issued by the authorized body ofthe country of origin (for manufacturers in the Republic of Armenia and CIS countries- manufacturing license if the GMP certificate is not available) (either original or verified copy)6. Brief description of the technological process, chemical, technological and equipmentschemes of production, including control of critical steps7. Data on pharmacokinetic and/or bioequivalence and acute toxicity studies of themedicinal product.8. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).9. Reference stating that above mentioned documents of medicinal product has not beenchanged since last registration.10. The label and packaging of the medicinal product or its color mock-ups andspecimens (also electronic version) for all presentations mentioned in the application .Appendix 1.5of documents required for the registration expertise of the additional dosages of the medicinal product registered in the Republic of Armenia1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Summary of Product Characteristics (original or verified copy).4. Instruction for use for specialists and patients..5. Qualitative and quantitative composition of the medicinal product (including excipients).6. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).7. Quality certificates of the active substances and excipients of the medicinal product.8. Data on stability study and shelf life of medicinal product.9. For veterinary medicinal products-information on maximum residue limits in thefoodstuff (meat, milk, egg, etc.). The time limitation of foodstuff use.10. The label and packaging of the medicinal product or its color mock-ups (alsoelectronic version) for all presentations mentioned in the application..11. TSE-Certificate of Suitability for the material of animal origin.Appendix 1.6of documents required for the registration expertise of the additional pharmaceutical forms of the medicinal product registered in the Republic ofArmenia1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Summary of Product Characteristics (Appendix 1.9).4. Instruction for use for specialists and patients..5. Qualitative and quantitative composition of the medicinal product (including excipients).6. Pharmacopoeial monograph(s) and/or control method(s) or specification(s) of thefinished medicinal product and its ingredients, packaging specification(s) (2 copies).7. Quality certificates of the active substances and excipients of the medicinal product.8. Data on stability study and shelf life of medicinal product.9. Data on pharmacokinetic and/or bio-equivalence and/or limited clinical studies of themedicinal product.10. Data on toxicity studies of the medicinal product.11. Data on clinical trials.12. For veterinary medicinal products-information on maximum residue limits in thefoodstuff (meat, milk, egg, etc.). The time limitation of foodstuff use.13. The label and packaging of the medicinal product or its color mock-ups andspecimens (also electronic version) for all presentations mentioned in the application..14. TSE-Certificate of Suitability for the material of animal origin.Appendix 1.7Listof documents required for the registration expertise of the new indications of the medicinal product registered in the Republic of Armenia.1. Application form (Appendix 1.8).2. Registration certificate of the medicinal product issued by the country of origin (eitheroriginal or verified copy).3. Summary of Product Characteristics (Appendix 1.9).4. Instruction for use for specialists and patients.5. Data on clinical efficacyAppendix 1.8 Data should be included in the application form1. Name of the medicinal product2. International Nonproprietary Name3. Composition* active substances* excipients4. Dosage strength5. Pharmaceutical form and route of administration6. Anatomical-clinical- chemical code (ATC)7. Presentation and packaging8. Indications9. Shelf-life10. Storage conditions11. Legal status for supply to the patient in the country of origin12. Manufacturer (name, address, country)13.Marketing authorization holder (name, address)13. Number and expiry date of registration certificate of patent and trade mark14. Applicant (manufacturer or its authorized representative), address, phone number(s), fax, signature, stamp or seal, date of signing.Appendix 1.9The summary of the product characteristics1. Name of the medicinal product2. Qualitative and quantitative composition with indication of active substances(international nonproprietary name or chemical name), indication of other excipients knowledge of which is essential for safe and proper administration of the medicinal product.3. Pharmaceutical form4. Clinical particularsTherapeutic indicationsPosology and method of administration (where appropriate dosage adjustments in specific patient group should be stated)ContraindicationsSpecial warnings and precautions for useInteractionsPregnancy and lactationEffects on ability to drive and use machinesUndesirable effectsOverdose5. Pharmacological properties5.1. Pharmacodynamic properties5.2 Pharmacokinetic properties5.3 Preclinical safety data6. Pharmaceutical particulars6.1 Excipients6.2 Incompatibilities6.3 Shelf-life6.4 Storage conditions6.5 Nature and contents of container6.6. Special precautions for disposal7. Manufacturer (name, address, country)8. Marketing Authorization holder (name, address, country)9. Date of final revision of the text.Appendix 2Listof minor changes of medicinal products registered in the Republic of Armenia thatdo not require new registration1. Changes in the content of GMP certificate or manufacturing license adopted by therelevant bodies of the country of origin that do not include the name, address or country of the manufacturer.2. Change in the name of a medicinal product (trade name and/or internationalnonproprietary name) in case the composition and indication of the finished product remain unchanged.3. Change in the name of manufacturer and/or the name of the marketingauthorization holder, in case the country of origin remains unchanged.4. Replacement of an excipient with a comparable excipient, except for the adjuvantfor vaccines or a biological excipient.5. Change or replacement of coloring agent currently used in the finished product.6. Addition, deletion or replacement of neutral flavoring agent currently used in thefinished product.7. Change in coating weight of tablets and change in weight of capsule shells.8. Changes in qualitative composition of immediate packaging except for sterileproducts.9. Deletion of one of the therapeutic indications of the finished product (in case safetycharacteristics remain unchanged).10. Deletion of one of the routes of administration.11. Change in the manufacturer of the active substance.12. Change in batch size of an active substance, in case quality control data of activesubstance indicate that consistency of manufacturing process remained unaffected and physical properties of active substance remain unchanged13. Changes in the specification of an active substance due to improvement of testprocedure, addition of new methods and tightening of specification limits.14. Changes in manufacturing process that do not involve a change of specification offinished product, in case the registration expertise of medicinal product for new manufacturing process proves that safety, efficiency and quality characteristics are unchanged.15. Change in batch size of the finished product, in case the consistency ofmanufacture remains unaffected.16. Changes in the specification of the finished product due to improvement of testprocedure, addition of new methods and tightening of specification limits.17. Changes in synthesis of excipients of the finished product, in case specifications,composition and quantitative impurity profile remain unchanged.18. Changes in specifications of excipients due to improvement test procedure,addition of new methods and tightening of specification limits.19. Change in the shelf life of the finished product in case of its prolongation, notexceeding five years.20. Change in the shelf life of the finished product after first opening.21. Change in the shelf life of the finished product after dilution or reconstitution22. Changes in the storage conditions of the finished product23. Changes in the methods of quality control of active substances of the finishedproduct24. Changes in the methods of quality control of the finished product25. Change to comply with an update of the relevant monograph of thePharmacopoeias26. Changes in testing methods of non-pharmacopoeial excipients27. Change to a test procedure of the immediate packaging of the finished product28. Changes in testing methods of the supplier or devices29. Changes in pack shape, size, design and number of units (e.g. tablets, ampoules,etc.) in a pack30. Change or addition of imprints, bossing or other markings on tablets or printing oncapsules.31. Change of dimensions of tablets, capsules, suppositories or pessaries withoutchange in quantitative composition and mean mass.Appendix 3FEESpayable for medicinal product registration expertise in the Republic of Armenia。
药品注册用英语
药品注册用英语现在做注册资料经常会涉及英语表达，为了使我们写注册资料时的英语更纯正，希望各位达人能积极勇跃提供经常涉及的英语表达,使我们的注册水平更上一层楼。
我先抛砖引玉CＥP：欧洲药典适应性证书certificate of suitabiliｔｙｔo moｎｏgraｐh oｆEuropean Pharｍａｃｏpoｅia。
是欧洲药典所收载的原料药的一种认证程序，用以确定原料药的质量可以用欧洲药典的方法加以控制。
这一程序适用于生产的和提取的有机或无机物质以及发酵生产的非直接基因产品。
ＤMF:Druｇｍaster Fｉle美国药物主文件档案。
是指提交给FＤA的用于提供关于人用药品的生产设备、工艺或生产、工艺处理、包装和储存中使用的物料的详细的和保密的信息。
分为五种类型：I:生产地点、设备、操作程序和人员II: 原料药、原料药中间体、生产原料药和中间体使用的物料和药品ＩII：包装材料IV：赋形剂、色素、调味剂、香料或生产这些物质所用的物料V：FDA接受的参考信息EDMF：European Drug MａsteｒFｉle欧洲药物主文件档案。
是指欧洲制剂申请中有关原料药信息的文件,又称原料药主文件档案（ASMF)。
EDＭF 只有在制剂申请的支持下才能提交。
EDMF分为两部分：1. 申请人部分(AP):供制剂申请人使用的非保密信息；2. 限制部分（RP）:ＥＤMF持有人认为是保密的信息。
EDMF的使用范围：1. 新原料药2. 已知的但欧洲药典或其成员国药典没有收载的原料药3. 欧洲药典或成员国药典已收载的原料药AＮDA:Abbreviated Nｅw Drug Ａpplicaｔion美国简略新药申请。
是FDＡ规定的仿制药申请程序。
Gｅneｒic:仿制的,非特殊的API：ActivｅPhaｒmaｃｅuticａl Ｉｎgreｄieｎｔ原料药Dosｓiｅr:文档,档案。
TSE:Tｒansｍｉtｔinｇanimal SponｇｉfｏrｍEncｅphalopathy aｇenｔ传播性动物海绵状脑病体Ｑ７Ａ：ＩCH（国际协调会议) 原料药GMP 指南。
关于新药注册申请提交CTD格式资料要求 (英文版)
2. 3. P DRUG PRODUCT (NAME, DOSAGE FORM)2.3.P.1 Description and Composition of the Drug Product（1）A description of the dosage of drug product and its composition should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table.(2) If there is special dissolvent, please fill the table as above.(3) Description of container and material of package.2.3.P.2Pharmaceutical DevelopmentSummarize the purpose of the development, including dosage, strength and reason of the selection.2.3.P.2.1 Components of the Drug Product2.3.P.2.1.1 Drug substanceSummarize the compatibility of the drug substance with excipients. Refer to 3.2.P.2.1.1 (Page: ) for the details.Additionally, summarize key physicochemical characteristics (e.g., solubility, particle size distribution, or crystal form) of the drug substance that can influence the performance of the drug product and also the control of all this characteristics.2.3.P.2.1.2 ExcipientsGenerally introduce the types and the tests and/ or reference of amount selection. Refer to 3.2.P.2.1.2 (Page: ) for the details.2.3.P.2.2Pharmaceutical Development2.3.P.2.2.1 Formulation DevelopmentRefer to 3.2.P.2.2.1(Page: ) for the process of formulation development and supportinginformation.A tabulated summary of the variation and reasons of formulation of different development steps, as well as supporting validation tests should be provided. For example:Excessive feeding: Supporting information about excessive feeding.2.3.P.2.2.2 Properties of drug productsSummary relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, polymorphism, rheological properties, should be addressed.The quality comparative tests results between the products and innovator in the formulation development should be provided. For example:(1)Dissolution of oral solid preparations: batch number, batch number and manufacture ofthe innovator; condition of dissolution, sampling points; comparative tests results.(2)Related substance: batch number, batch number and manufacture of the innovator;methods of tests and calculation; comparative tests results.2.3.P.2.3 Manufacturing Process DevelopmentRefer to 3.2.P.2.3(Page: ) for the details of the selection and optimization of manufacturing process.A tabulated summary of the variation and related supporting research information from lab scale tests to large scale tests, including batch size, devices, parameters, etc. should be provided.Example:Summary of the variation of manufacturing processSummarized the sample condition of representative batches (including but not limited to clinical research batch, pilot scale batch, on-site verification batch, process validation batch). Batch number, manufacture date and address, batch scale, purpose (eg. Stability tests, BE tests, etc.), analysis results(eg. Related substance, dissolution and other quality indications) Example:Summary of batch analysis2.3.P.2.4 Packing material/ Container*including material and strength**including the accessories which contact the drug directly, such as c ombined with polypropylene plastic containers infusion and plastic containers with polypropylene interface infusionRefer to 3.2.P.2.4 (Page: ) for the details.2.3.P.2.5 CompatibilitySummarize the compatibility of the drug product with diluent(s) or dosage devices. Refer to 3.2.P.2.5 (Page: ) for the details.2.3.P.3 Manufacture2.3.P.3.1 ManufacturesThe name (full name), address, telephone number and fax of each manufacturer and each proposed production site or facility involved in manufacturing and testing should be provided.2.3.P.3.2 batch formulaA description of the composition of drug product in scale for production should be provided with a table to present the action of each composition and the specification. Overages should be explained and the dissolvent which is used but removed in the end should be in the table.2.3.P.3.3 Manufacturing Process and Process Controls(1) flow diagram of process: refer to 3.2.P.3.3 (Page: )(2) description of manufacturing process: Main processes, parameters and scales should be identified by a brief description of each manufacturing process (including steps). Refer to 3.2.P.3.3 (Page: )(3) Main equipments: Refer to 3.2.P.3.3 (Page: )(4) draft scale of large production: units of drug product/batch (oral preparation, etc. ) or volume of solution before filled/batch (solution, injection, etc).2.3.P.3.4 Controls of Critical Steps and IntermediatesList all the critical steps and the parameter control ranges of manufacture processRefer to 3.2.P.3.4 for the details of identification of critical steps and the parameter control ranges of manufacture process.Refer to 3.2.P.3.4 for the details of quality control of intermediates2.3.P.3.5 Process Validation and Evaluationaseptic and specified processing preparation: protocol of process validation (No. version number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: )other preparation: protocol of process validation (No. version number: ) and validation report (No. version number: ). Refer to 3.2.P.3.5(Page: ); Otherwise, protocol of process validation (No. version number: ) and report of batch production (No. version number: ). Refer to 3.2.P.3.5 for the details of draft and validation undertaking (Page: )2.3.P.4Control of Drug substance and Excipients2.3.P.5Control of Drug Product2.3.P.5.1 SpecificationA tabulated summary of specification should be provided as below. If there are release and shelf life specification, please explain each one in the table. Refer to 3.2.P.5.1(Page: ) for the details of specification.2.3.P.5.2 analysis methodsList chromatographic condition of each method: degradation substance, resident solvent, assay, etc.List the dissolution condition and quantitative method, etc.Refer to 3.2.P.5.2 for the details of analysis methods.2.3.P.5.3 Validation of Analytical ProceduresThe validation results should be tabulated as following:Example:Method validation of related substanceRefer to 3.2.P.5.3 (Page: )2.3.P.5.4 Certificate of analysisRefer to 3.2.P.5.4(Page: ) for the COAs of 3 batches(batch number: )2.3.P.5.5 Impurity analysisA tabulated summary of impurities should be supplied.For example:Analysis of impuritiesRefer to 3.2.P.5.5 for the details(Page: )2.3.P.5.6 Justification of SpecificationRefer to 3.2.P.5.6 for the details(Page: )2.3.P.6 Reference StandardsPharmacopoeia Reference: resource, batch numberWorking standard: summarize the methods and results of standardization of assay and purification2.3.P.7 Stability2.3.P.7.1 Summary of stability(1) sample:(2) testsStability resultsIn-use stability results2.3.P.7.2 Post-marketing stability commitment and protocolRefer to 3.2.P.7.2 for the details (Page: )Draft packing material, storage condition and shelf-life should be listed as follow:2.3.P.7.3 Raw data of stabilityTabulate the tests results, and refer to 3.2.P.7.2 for the details(Page: ) Example:。
药品申请专业英语
abbreviated or abridged application简略申请abnormal karyology异常核型absorbed moisture 吸附水acceptable daily intake可接受的日摄入量acceptable test加速试验acceptance criteria认可标准accuracy准确性accelerated/stress stability studies加速/强力破坏稳定性研究acetylation乙酰化作用achiral assay非手性测定achlorhydric elderly老年性胃酸缺乏症action limits内控限值active components/compound/moiety活性成分active ingredient活性组分adaption to specific culture conditions特定培养条件的适应additives添加剂adjuvant佐剂adventitious agents外源性因子adventitious contaminants 外来污染物adventitious viral or mycoplasma contamination外源性病毒或支原体污染adventitious viruses外源病毒adverse reaction不良反应aerobic microorganisms需氧微生物affinity 亲和力affinity chromatography亲和层析affinity column亲和柱agar and broth琼脂和肉汤aggregates聚合体aggregation聚集allergenic/allergic extracts过敏源抽提物altered conjugated forms改变的结合物形式ambient condition自然条件amino acid composition氨基酸组成amino acid sequence氨基酸序列amino acids氨基酸amino sugars氨基糖amino-terminal amino acids 氨基端氨基酸ammonia production Rates产氨率analyte被测物analytical procedure分析方法animal cell lines动物细胞系animal tissues or organs动物组织或器官anternnary profile触角形状antibiotic resistance genes抗生素耐药基因antibiotics抗生素antibody抗体antibody production tests抗体产生实验antisera抗血清applicant申报者ascites腹水assay含量测定assay procedure定量方法avian鸟类avidity亲和性background背景bacteria细菌batches批次batch-to-batch逐批between-assay variation试验间变异binary fission双数分裂binding assays结合试验bioburden生长量/生物负荷biochemical methods生化方法bioequivalency生物等效性biohazard information生物有害信息biological ativity生物活性biological products生物制品bioreactor生物反应器biotechnological/biological products生物技术/生物产品biotechnological products生物技术产品biphasic curve双相曲线blood plasma fators血浆因子body fluids体液bovine牛bovine spongiform encephalopathy(BSE)疯牛病bracketing括号法breeding conditions饲养条件by-prducts副产物calibrate标化canine犬cap liner瓶帽内垫capillary electrophoresis毛细管电泳carbohydrate碳水化合物carboxy-terminal amino acids碳基端氨基酸carrier载体/担体catalysts催化剂cell bank细胞库cell bank system细胞库系统cell banking procedures细胞建库过程cell banking system细胞库系统cell culture-derived impurities来源于细胞培养基的杂质cell cultures细胞培养物cell expansion细胞扩增cell lines细胞系cell metabolites细胞代谢物cell pooling细胞混合cell substrate-derived impurities来源于细胞培养基质的杂质cell substrates细胞基质cell viability细胞活力cell–derived biological products细胞来源的生物制品cell fusion细胞融合cellular blood components血细胞成分cemadsorbing viruses红细胞吸附病毒characterization and testing of cell banks细胞库鉴定及检测charcoal活性炭charge电荷chemical actinometric system化学光化线强度系统chemical reactivity化学反应性chemical syntheses化学合成chemically inert化学惰性chewable tablets咀嚼片chiral impurities手性杂质chromatograms色谱图chromatographic behavior色谱行为chromatographic procedures色谱方法chromatography columns色谱柱circular dichroism圆二色性clearance studies清除研究climatic zones气候带clinical research临床研究clinical trial application临床实验申请cloning克隆closure闭塞物code number编号coding sequence编码序列coefficient of variance变异系数collaborative studies协作实验研究colony isolation菌落分离colony-stimulating factors集落刺激因子combination product复方制剂components成分confidence interval置信区间confidence limits 可信限confirmatory studies确认研究conformance to specifications符合规范conformation构型conjugated product连接产物consistency一致性container容器container/closure容器/闭塞物container/closure integrity testing 容器/密封完整性实验contaminants污染物content uniformity含量均匀性control methodology控制方法学controlled released product控制制剂conventional vaccines传统疫苗conventional live virus vaccines传统的活病毒疫苗cool white fluorescent冷白荧光灯correction factor校正因子correlation coefficient相关系数covalent or noncovalent共价或非共价creams霜剂cross-contamination交叉污染cross-reactivity交叉反应cryopreservation冷冻保存cryoprotectants防冻剂crystals晶体culture components培养基成分culture media/medium培养基cyanogens bromide溴化氰cytogenetic细胞遗传学的cytokines细胞因子cytopathic细胞病的cytoplasmic A-and R-type particles细胞浆a型和r型颗粒dark control暗度对照deamidation 去氨基deaminated去酰胺化的decision flow chart/tree判断图definable and measurable biological activity明确和可测定的生物学活性degradant降解产物degradation降解degradation pathway降解途径degradation product降解产物degradation profile降解概况degree of aggregation 凝集程度degree of scatter离散程度delayed –release延迟释放deleterious有害的delivery systems给药体系derivatives衍生物description性状detection limit检测限度dilivery systems释放系统dilution ratio稀释倍数dimmers二聚体diode array二极管阵列diploid cells二倍体细胞dissociation解离dissolution testing 溶出实验dissolution time溶出时间dosage form剂型downstream purification下游纯化drug product制剂drug product components制剂组方drug substances原料药ectromelia virus脱脚病病毒elastomeric closures橡皮塞electron microscopy (EM)电镜electrophoresis电泳electrophoretic pattern电泳图谱elution profile洗脱方案embryonated eggs鸡胚enantiomer对映体enantiomeric对映异构体enantioselective对映体选择性encephalomyocarditis virus(EMC)脑心肌炎病毒endogenous agents内源性因子endogenous retrovirus内源性逆转录病毒endotoxins内毒素end-product sterility testing 最终产品的无菌试验enhancers增强子enveloped RNA viruses包膜RNA病毒environmental factors环境因素enzymatic reaction rates酶反应速率enzyme酶epitope表位Epstein-Barr virus(EBV)EB病毒equine马Erythropoietins促红细胞生成素ethnic origin种族起源eukaryotic cell真核细胞ex vivo体外excipient赋形剂excipient specifications赋形剂规范expiration date/dating 失效日期exposure level暴露程度exposure period光照时间expression constract表达构建体expression system表达系统expression vector表达载体extended-release延时释放extent of the virus test病毒测试程度extinction coefficient消光系数extrachromosomal染色体外extraneous contaminants 外源性污染物exprapolation外推法fermentation发酵fermantation products发酵产物fill volume装量filter aids过滤介质final manufacturing最终生产finished product成品flanking region侧翼区forced degradation testing 强制降解物质foreign matter异质性物质formal labeling 正式标签formal stability studies正式的稳定性研究formulation处方/配方fragmentation片段化freeze-dried product冻干产品friability脆硬度fungi真菌fusion partnters融合伴侣fusion protein融合蛋白gel filtration凝胶过滤gene amplification基因扩增gene therapy基因疗法generation of the cell substance细胞基质的产生genetic manipulation基因操作genomic dinucleotide repeats基因组双核苷酸重复数genomic DNA基因组DNAgenomic polymorphism pattern基因组形态类型glucose consumption rates耗糖率glycoforms糖化形式glycosylation糖基化goegrapgical origin地理起源growth factors生长因子growth hormones生长激素guanidine胍hamster antibody production (HAP) test仓鼠抗体产生实验Hantaan virus汗坦病毒Hardness硬度heavy metals重金属heparins肝素herbal products 草药herpes virus疱疹病毒heterogeneities异质性heterohybrid cell lines异种杂交细胞系high-resolution chromatography高分辨色谱homogeneity均一性host cell宿主细胞host cell banks宿主细胞库host cell DNA宿主细胞DNAhost cell proteins宿主细胞蛋白质hot-stage microscopy热阶显微镜human diploid fibroblasts人二倍体呈纤维细胞human polio virus人脊髓灰质炎病毒human tropism人向性humidity湿度humidity-protecting containers防湿容器hybridization techniques杂交技术hybridoma cell杂交瘤hybridomas水解物hydrolysates水解物hydrolytic enzymes水解酶hydrophobicity疏水性hygroscopic吸湿性idetification/identity鉴别immediate container/closure直接接触的容器/密闭物immediate pack内包装immediate release立即释放immortalization激活immune spleen cells免疫脾细胞immumoassay免疫检测immunochemical methods免疫化学方法immunochemical properties免疫化学性质immunoelectrophoresis免疫电泳immunogenicity免疫原性immunological interations免疫相互作用immunoreactivity免疫反应性impurity profile杂质概况in vitro and in vivo inoculation tests体内和体外接种试验in vitro assay体外检测in vitro cell体外细胞传代期in vitro lifespan体外生命周期in vitro tests体外试验in vivo 体内in vivo assays体内检测inactivated vaccine灭活疫苗indentification test鉴别试验indicator cell指示细胞indicator organisms指示菌indoor indirect daylight室内间接日光inducers诱导剂infectious agents感染性因子influenza virus流感病毒inhalation dosage forms吸入剂型in-house内部的in-house criteria内控标准in-house primary reference material内部一级参比物质in-house working reference material内部参比物质initial filing原始文件initial submission最初申报initial text最初文件inoculation接种inorganic impurities无机杂质inorganic mineral无机矿物质inorganic salts无机盐in-process acceptance criteia生产过程认可标准in-process controls生产过程中控制in-process testing生产过程中检测insect昆虫insulins胰岛素intake摄入intended effect预期效果intended storage period预期的储藏期intentional degradation人为降解interactions相互作用interferon干扰素interleukins白细胞介素intermediate中间体intermediate precision中间精密度intermediates半成品international reference standards国际参比标准品intra-assay precision间隙含量精密度intracytoplasmic细胞浆内introduction of virus病毒介入inverted or horizontal position倒立或水平位置ion-exchange离子交换ionic content离子含量isoelectric focusing/isoelectrofocusing等电聚焦isoenzyme analysis同工酶分析isoform pattern异构体类型isomerized异构化的Jp /Ph.Eur./Usp.日本药局方/欧洲药典/美国药典K virus K病毒Karyology胞核学laboratory scale实验室规模lactate production rates乳糖产生速率litric deheydrogenase virus(LDM)乳酸脱氢酶病毒leachables沥出物ligand配位体/配体light光照light resistant packaging避光包装limit for in vitro cell细胞体外传代限度limit of acceptance可接受的限度limit of in vitro cell体外细胞代次limit test限度试验limulus amoebocyte lysate鲎试剂linear relation ship线性关系linearity线性liquid nitrogen液氮liquid oral dosage forms液体口服制剂live vaccine活疫苗living cells活细胞logarithmic scale对数级long term test长期试验long-time and accelerated stability长期和加速稳定性试验losses of activity活性丧失lot release批签发low molecular weight substances低分子量物质lower-observed effect level(LOEL)能观察到反应的最低量lymphocytic choriomeningitis virus(LCM)淋巴细胞性脉络丛脑膜炎病毒lyophilised cakes冻干粉饼lysate of cells细胞溶解物mammalian哺乳类manufacturing scale生产规模marker chromosome标志染色体marketing pack上市包装mass重量mass balance质量平衡mass spectrometry质谱master cell bank (MCB)主细胞库material balance物质平衡matrix基质,矩阵matrix system矩阵法matrixing 矩阵化设计maximum daily dose每日最大剂量mean kinetic temperature平均动力学温度metazoan cell culture后生动物细胞培养microbial cell culture微生物细胞培养microbial cells微生物细胞microbial contamination微生物污染microbial expression system微生物表达系统microbial limits微生物限度microbial metabolites微生物代谢物microbial proteases微生物蛋白酶microbial vaccine antigens微生物疫苗抗原microbiological testing微生物学试验minimum exposure time最低作用时间minimum of pilot plant试验规模minute virus of mice小鼠小病毒mirror image镜像mismatched S-S linked错连的S-S键mork run空白对照试验modified-/modifying release修饰释放modifying factor修正因子moisture level水分molar asorptivity克分子吸收molecular characteristics分子特性molecular confirmation分子构型molecular entities/entity分子实体molecular size分子大小monoclonal antibody单克隆抗体morphological analysis形态学分析mouse antibody production (MAP) test小鼠抗体产生试验mouse cytomegalovirus(MCMV)小鼠巨细胞病毒mouse encephalomyelitis virus(GDVⅡ)小鼠脑脊髓炎病毒mouse hepatitis virus(MHV)小鼠肝炎病毒mouse rotavirus(EDIM)小鼠小轮状病毒MuLV murine leukemia virus鼠白血病病毒murine hybridoma cell lines鼠杂交瘤细胞系mutations突变mycoplasma支原体myeloma cell line骨髓瘤细胞系national or international reference material国家或国际参比物质near ultraviolet lamp近紫外灯neural sugars中性糖new chemical entry 新化学体new dosage form新剂型new drug products/produce新药制剂new drug substance新原料药new molecular entities新分子体no effect level不产生反应的量noncovalent/convalent force非共价/共价键non-enveloped viruses非包膜病毒non-mammalian animal cell lines非哺乳动物细胞系non-recombinant cell-culture expression systems非重组细胞培养表达系统non-recombinant products/vaccines非重组制品/疫苗non-specific model virus 非特异模型病毒no-observed effect level不能观察到反应的量N-terminal sequencing N-端测序nuclear magnetic resonance核磁共振official procedure正式方法ointments软膏oligosaccharide pattern低聚核苷酸opacity浊度origins of replication复制起点osmolality摩尔渗透压浓度outdoor daylight室外阳光oxidation氧化oxygen consumption rates耗氧率package包装parainfluenza virus副流感病毒parallel control assays平行对照分析parent stability Guideline稳定性试验总指导原则patrental cell line母细胞系parenterals非肠道制剂particle size粒度particulate matter微粒parvoviruses细小病毒passage history of the cell line细胞系的传代史pathogenic agents致病因子pathogenicity致病性patterns of degradation降解方式peptide肽peptide map肽图percent recovery回收率periodic/skip testing定期检验/抽验permitted daily exposure允许的日接触量phage typing 噬菌体分型pharcodynamic studies药效学研究pharmacopoeial药典pharmacopoeial specifications药典规范pharmacopoeial standards药典标准phenotypic表型phosphorylation磷酸化作用photostability testing光稳定性试验physicochemical changes理化改变physicochemical methods物理化学方法physico-chemical properties物理化学特性pilot-plant scale试生产规模/中试规模piston release force活塞释放力piston travel force活塞移动力pivotal stability studies关键的稳定性研究plaque assays菌斑测定plasmid质粒plasmid banks质粒库plasminogen activators纤溶酶原激活素pneumonia virus of mice小鼠肺炎病毒Poisson distibution泊松分布polymorphic form多克隆抗体polymorphse chain reaction(PCR)聚合酶链式反应polymorphic form多晶性型polymorphs多晶型polyoma virus多瘤病毒pooled harvest集中回收population doubling细胞鼠倍增/群体倍增porcine猪post-approval批准后post-translational modification翻译后修饰post-translationally modified forms翻译后修饰形式potency效价potent功效potential adverse consequences潜在的不良后果potential excipients准赋形剂potential impurity潜在杂质potential new drug products准新药制剂potential new drug substances准新原料药potentiometric titrimetry电位滴定powders粉剂power outages and human error断电和人为错误preamble引言pre-approval or pre-liscense stage批准前或发证前阶段precision精密度preclinical and clinical studies临床前和临床研究precursors前体preliminary assessment初步评估preliminary cell bank初级细胞库preparation制剂preservative防腐剂primary cells原代细胞primary stability data主要稳定性数据primary stability study/formal study/formal stability study主要稳定性研究/正式研究/正式稳定性研究primary structure一级结构primer引物priming regimen(s)接种方式probability概率process characterization studies工艺鉴定研究process controls工艺控制process optimization工艺优化process parameters工艺参数process validation工艺确证process –related impurities工艺相关杂质product-related impurities产品相关杂质progenitor祖细胞prokaryotic cell原核细胞promoters启动子proposed commercial process模拟上市protected samples避光样品proteins蛋白质分析技术proteolysis蛋白水解protocol方案pseudopolymorphs伪多晶体pseudorabies virus假狂犬病毒purification纯化purified antigens纯化抗原purity纯度purity test纯度试验pyrogens热原试验qualification界定qualified 合格的quality standards质量标准quantal methods质反应测定法quantitation limit定量限度quantitative characteristics定量参数quantitative detection定量检测quantitative infectivity assays感染性定量测定quantitative method定量方法quantitative test定量试验quantitative virus病毒定量分析quantity含量racemate消旋体radiometers/lux meters测光仪/照度仪radiopharmaceutical放射性药物range范围rat antibody production (RAP) test大鼠抗体产生试验rationale基本原理raw material原材料raw material testing原材料测试rDNA technology重组DNA技术rDNA-modified cell substrates重组DNA修饰的细胞基质reagent试剂,反应物real condition真实条件real time 真实时间rebank 再建库receptor受体reclone再克隆recombinant cell-culture expression systems 重组细胞培养表达系统recombinant DNA protein products重组DNA蛋白质产品recomibinant-DNA-derived product重组DNA制品recombinant protein重组蛋白质reconstitution重新溶解redispersibility再分散性reduction factors下降因子reference material参比物质reference standard参比标准品regimen方案registration application注册申请regression analysis回归分析regulator/regulatory agencies管理机构related substances有关物质release limit出厂限度"relevant" viruses and "model" viruses"相关"病毒和"模型"病毒reovirus type3(Reo 3)呼吸肠病毒repeatability重复性reproducibility 重现性residual solvents残留溶剂residual sum of squares溶剂残留量resolution test分离度试验response factor响应因子restriction endonuclease mapping限制性内切酶图谱restriction fragment length polymorphism限制性片段长度多态性resuspension再悬浮retention time保留时间retest date再试验日期reverse transcriptase(RT)反转录酶reversed-phase chromatography反相色谱reverse-phase liquid chromatography反相液相色谱revived cells复苏的细胞rheological properties流体学特性risk-benefit analysis利弊分析robustness耐用性rodent retrovirus啮齿类动物逆转录病毒sampling采样scale-up放大scaling down缩小规模scope范围scrapie瘙痒病screening tests筛选试验SDS-PAGE/SDS-polyacrylamide gel electrophoresis十二烷基硫酸钠-聚丙烯酰胺凝胶电泳sealed ampoules密封安瓿secondary structure二级结构self-replicating agents自我复制因子semi-synthetic products半合成产品Sendai virus仙台病毒Sensitivity灵敏度Senescence老化Separation分离Serum血清Shear切变shelf life货价寿命shipment运输sialic acids唾液酸signal-to-noise信噪比Sindbis virus新德比病毒single-dose and multiple-dose packages单剂量和多剂量包装single-point measurements单点测定single-tiered banking system单级细胞库系统size exclusion chromatography分子排阻色谱skip lot testing随机试验slope of the regression line回归线的斜率solid oral doseage固体口服制剂solvates溶剂化物solvation溶剂化作用solvent溶剂species物种specific gravity比重specific objectionable bacteria控制菌specification规范specification limit规范限度specification –check质控规范specification-release出厂规范specifications规范specificity专属性specified impurities特定杂质specified light exposure特定的光照spectroscopic profiles光谱图spiked samples加料样品spiking experiments叠加试验splicing sequences剪接序列stabilizers稳定剂stability data稳定性资料stability evaluation稳定性评价stability proticol稳定性方案stability study duration稳定性试验期限stability testing稳定性试验stability-indicating profile反应稳定性指标standard deviation标准差standard stock solution标准储备液starting materials起始物statement/labeling说明/标签statistical analysis统计学分析sterility无菌storage condition放置条件strains品系stress condition强力破坏试验条件stress testing强力破坏试验storage conditions储存条件structural heterogeneity结构异质性subcultivations传代培养sulfhydryl groups and disulfide bridges巯基和二硫键sulfoxidation硫酰化support information辅助性资料surrogate test替代试验surrogates替代物suspensions混悬剂swine猪synthesis合成synthetic peptides合成肽syringeability灌注功能systemic exposure全身接触tablet cores片芯tandem repeats串联重复target molecule靶分子temperature changes温度变化terminology术语tertiary structure三级结构test criteria试验标准test intervals试验间隔test parameters试验参数testing frequency试验次数texture质地the method of least squares最小二乘法threshold limits阈值thymic virus胸腺病毒tip cap removal force滴帽移动力tissue-culture-infectious-dose(TCID)组织培养感染剂量titration滴定法tolerable daily intake可耐受的日摄入量toolan virus(Hi)图兰病毒topical formulations局部用药处方toxic impurity毒性杂质toxin毒素tranfection of matazoan cells后生动物细胞的转染transcrption转录transdermal systems透皮吸收系统transfection转染transfomation转化translational fidelity翻译的忠实性transmission electron microscopy电透镜transparent cover透明盖子truncated forms截短形式tumor necrosis factor肿瘤坏死因子tumorigenicity致瘤性two-tiered cell bank两级细胞库uncloned cell population未克隆的细胞群unicellular life forms单细胞生命形式unidentified impurities未确定杂质uniformity of content 含量均匀度uniformity of dosage units剂量单位的均匀度uniformity of fill装填均匀度uniformity of mass质量均匀度unitage单位universal tests/criteria常规试验/标准untransfected recipient cell line未转染的受体细胞系UV/visible wavelength紫外可见光波长Vacinnes疫苗Validation论证variant sequences变异序列variants 变异体vector载体vehicle载体/溶酶vesicular stomatitis virus小囊状口腔炎病毒viral clearance病毒清除viral clearance studies病毒清除研究viral contamination病毒污染viral geneme病毒基因组viral infectivity病毒感染性viral safety evaluation病毒安全评估viral vicinnes病毒性疫苗virucidal buffers杀病毒缓冲液virus load 病毒浓度virus titer病毒滴度viscosity粘度visible particulates可见颗粒visual appearance外观visual evaluation直观评价vitamins 维生素water of hydration结晶水well-defined testing program确定的试验项目western blot免疫印迹whole blood全血within-assay variation试验内变异working cell bank工作细胞库yeast酵母y-intercept y轴上的截距。
药品申请注册所需材料英文版Declarationmaterials
药品申请注册所需材料英文版DeclarationmaterialsDeclaration materialsPart1: Overview materials1. Name of the medicines2. Profiles of proof3.Purpose and evidence of the proposal4.Summary and review of main research results5.Medicine directions, draft instructions and related references6. Design drafts of the package and logo.Part2: Pharmaceutical research materials7.Overview of pharmaceutical research8.Research and reference materials of API manufacturing process; Research and reference materials of prescriptions and manufacturing process of preparations.9.Experimental materials and references of confirming medicine chemical structure or components10.Experimental materials and references of quality research11.Pharmaceutical standards and draft instructions with standard products or control samples12.Analytical report of samples13.The source, quality standard and analytical reports of API and adjuvants14.Experimental materials and references of medicine stability research15.Selection criteria and quality standards of packing materials and containers which directly contact the medicine Part3: Pharmacological and toxicological research materials16.Overview of pharmacological and toxicological researchmaterials17.Main pharmacodynamic experimental materials and references18.General pharmacological experimental materials and references19.Acute toxicity experimental materials and references20.Long-term experimental materials and references21.Allergic (partial, systemic and photosensitive toxicity), hemolytic and partial stimulation (blood vessels, skin, mucosa and muscles, etc.) and other special safety experimental materials and references22.Experimental materials and references of interactions of multi-components’ properties, toxicity and pharmacokinetics in compound preparation23.Mutagenic experimental materials and references24.Reproductive toxicity experimental materials and references25.Carcinogenic experimental materials and references26.Dependence experimental materials and references27.Non-clinical pharmacokinetic experimental materials and referencesPart4: Clinical experimental materials28.Overview of domestic and overseas relating clinical experimental materials29.Clinical test plan and research scheme30.Clinical researchers’ manual31.ICF sample manuscript, Ethics committee’s approval32.Clinical test reportsPS: Part 2 (Pharmaceutical research materials) is supposed to be sorted according to module 3, CTD. Specific requests of CFDAare consistent with that of FDA. Some details need to be discussed specifically and CFDA may have more requests than FDA does.。
进口药品注册资料-中英对照
注册分类4、5.2类申报资料要求(试行)一、申报资料项目Application File Item（一）概要Summary1.药品名称。
Drug name2.证明性文件。
Certified document2.1注册分类4类证明性文件Certified document of class 4 product byregister classification.2.2注册分类5.2类证明性文件Certified document of class 5.2 product byregister classification.3.立题目的与依据。
Purpose and basis of subject selection4.自评估报告。
Self-assessment report5.上市许可人信息。
Listed Licensee information6. 原研药品信息。
Innovator product information7.药品说明书、起草说明及相关参考文献。
Package insert, drafting Instruction and related references8.包装、标签设计样稿。
Design comps of product packaging and label.（二）原料药Drug Substance (API)9.（2.3.S,注:括号内为CTD格式的编号，以下同）原料药药学研究信息汇总表。
(2.3.S, Note: Figures in bracket are numbers in CTD format, the same below) Summary of Pharmaceutical Study Information of Drug Substance (API)10.（3.2.S）原料药药学申报资料。
Pharmaceutical Applification Files of Drug Substance (API)10.1．（3.2.S.1）基本信息General Information10.2．（3.2.S.2）生产信息Manufacture10.3.（3.2.S.3）特性鉴定Characterization10.4.（3.2.S.4）原料药的质量控制Control of Drug Substance10.5.（3.2.S.5）对照品Reference Standards10.6.（3.2.S.6）包装材料和容器Container Clouser System10.7.（3.2.S.7）稳定性Stability（三）制剂Drug Product11. （2.3.P）制剂药学研究信息汇总表。
5.2类药品注册申报资料要求（英文版）
I.Summary of the drug2.Certificated Documents2.1 Notarized and Authenticated Free Sale Certificate by Embassy ofChina2.2 Notarized and Authenticated GMP Certificate by Embassy of China2.3 Notarized and Authenticated Letter of Authorization/Power ofAttorney by Embassy of China2.4 Patent Declaration2.5 Notarized and Authenticated CEP Certificate by Embassy of China, ifhas CEP2.6 DMF No. in US FDA, certificates of marketing authorization approvalof the drug products which the DMF referenced, GMP certificate of thedrug products’ companies. All documents should be Notarized andAuthenticated by Embassy of China3. Objectives and basis for R & D4. Self-Assessment Report The applicant should evaluate the generic drugs intends to register based on 1) whether the original drug was the first marketed or not;2) complete and sufficient data for safety and efficacy; 3) the rationality of the manufacture process of the generic drugs intend to register; 4) practicability of commercial manufacture; 5) the controllability and stability of the generic drugs intend to register. The applicant should estimate whether all evaluations of the generic drugs intends to register can support the Registration Application or not? The applicant should establish a scientific committee. The committee should audit the R&D progress and results, registration dossier to guarantee the scientificity, completeness and authenticity of the data. The self-assessment report on research documents should be provided.5. Information of Marketing Authorization Holder5.1 the copies of register documents (business license and etc.) of the drug manufacture and the drug R&D agency5.2 the copies of ID card of the R&D people, personal credit report, resume (includes education background, work experience on drug R&D) and credibility and integrity commitment statement5.3 If the marketing authorization holder is drug R&D agency or drug R&D people, the commitment statement of the responsibility of the drug quality should be provided. In the statement it should commit to provide the Guarantee Agreement with the Guarantee Agency or the Insurance Contract with the Insurance Agency to the provincial drug supervision authorities before the drug marketed.6. Information of original drug6.1 The definition of the original drug is the first approved marketed drug which has complete and sufficient data on safety and efficacy as evidence for marketing.6.2 The table of the information of the original drug6.3 the following documents should be provided as annexes: the certificate of the legal source of the original drug (purchasing order/contract, invoice, donation certificate statement), pictures of the original drug used as reference standard, packaging insert, other necessary documents7. Draft of packaging insert, note to the draft, and latest literature8. Specimen of the designed packaging and labelingII.API/Bulk Drug9.Quality Overall Summary → CTD 2.3.S. The electronic word (.doc/.docx)version should be provided10.Pharmaceutical Data of API/Bulk Drug10.1General Information → 3.2.S.13.2.S.1.3 →also includes partition coefficient, dissociation constant,the BCS classification.10.2Manufacture3.2.S.2.2 →equipments: the information of the main equipments(such as type, material, operation principle, common batch size,manufacturer, used in which step). The suitability of the equipmentswith the current biggest batch size should be discussed. Theproposed batch size range.3.2.S.2.3 → The internal specifications, analytical methods, andvalidation of the analytical methods of the materials should beprovided. The manufacture process of the starting materials whichoutsourced should be provided and it should analyze and control theimpurities. The test reports and spectra of several batches of theoutsourced starting materials should be provided. The audit planand audit report on the suppliers of the critical starting materialsshould be provided.3.2.S.2.4 → identify the by-products, the control and limit of the by-products. The test results and spectra of several batches of thesamples should be provided.10.3Characterisation3.2.S.3.1 → The detailed studies documents/reports to prove thecrystalline form of the drug intend to register is same as the original drug. If not same crystalline form, it should provide sufficientevidence.10.4Control of Drug Substance3.2.S.4.1 → The comparison table of the specifications should beprovided.3.2.S.4.2 → the comparison of analytical methods should beprovided.3.2.S.4.5 the comparison of quality of 3 batches of the drugintends to register vs original drug.The comparison of the impurities.If the original drug was not available, it can use the impuritiesstudies documents of the drug product/preparation.All spectra of the above studies should be provided.10.5Reference Standards or MaterialsIf the reference standards were purchased from USP/EP…., thepurchasing documents (contract, invoice…), pictures of thereference standards, copies of the label of the reference standards, the source, batch No and purity of the reference standards should be provided.If the reference standards were purchased from other non-pharmacopeia or prepared by applicant, the purchasing documents (contract, invoice…)/manufacturing process/test reports, elucidation of the structure, specification, the calibrating process of the assayand purity should be provided.10.6Container Closure System10.7Stability3.2.S.7.1 → if the analytical methods used in stability studies weredifferent with 3.2.S.4, the detailed analytical methods and validation reports should be provided.→ Conclusion: comparison of stability3.2.S.7.2 → post-approval stability study protocol should beprovided.3.2.S.7.3 → The copies of the total analysis/test report of thesamples, the exact location where the samples placed, theequipment No., the quantities of the samples of each time pointsshould be provided. The chromatographic data and spectra should be provided as annex.。
cde申报资料模板
cde申报资料模板CDE(China Drug Evaluation)申报资料是指在中国进行药物注册申报时所需要提交的相关材料。
这些资料主要用于对药物的安全性、有效性和质量进行评价，并最终决定是否批准该药物上市。
为了帮助申报人员准备相应的申报资料，以下是一份相关参考内容，供申报人员参考。
一、企业资质文件1.1 企业营业执照副本复印件1.2 企业生产许可证副本复印件1.3 企业药品生产许可证副本复印件1.4 企业药品GMP证书复印件二、研究开发资料2.1 药物研发计划：包括研究目标、研究设计、研究方案等相关信息2.2 药物临床试验资料：包括临床试验计划、试验结果、药物临床安全性评估等信息2.3 临床试验伦理委员会批准文件及委员会评估报告2.4 药物质量控制文件：包括药物的质量标准和质量控制方法等信息2.5 药物不良反应监测和报告文件：包括不良反应的监测和报告方法、不良反应事件的报告记录等信息三、药物监管文件3.1 药物批准文件：包括国内外相关药物批准文件的复印件3.2 国内外相关药物市场情况的调查分析报告四、药物学资料4.1 药物化学和配方学资料：包括药物的化学结构、化学性质以及配方的成分和比例等信息4.2 药物制剂学资料：包括药物的制剂形式、质量控制和稳定性等信息4.3 药物药理学资料：包括药物的作用机制、药效学、药动学以及药物之间的相互作用等信息4.4 药物毒理学资料：包括药物的急性毒性、亚急性毒性、慢性毒性以及生殖毒性等信息五、药物临床试验资料5.1 药物临床试验同意书和知情同意书5.2 药物临床试验方案和研究计划5.3 药物临床试验结果的统计分析报告5.4 药物临床试验的不良反应监测和报告文件六、药物充分性和适应性资料6.1 药物充分性资料：包括药物的临床试验结果、药物安全性和有效性的评价等信息6.2 药物适应性资料：包括药物的适应症、用法和用量等信息以上是CDE申报资料模板的相关参考内容，具体的申报要求还需要根据相关法规和CDE的相关通知进行调整。
化学药品新注册分类申报资料要求 英文版-5.1类
Application Information Requirements of Chemical Drugs as per new registration categoryChapter IApplication Information Requirements for Category 1, 2, 3, 5.1I. Required items(I) Summary1. Name of the drug2. Certified Documents2.1 Certified documents for category 1, 2, 32.2 Certified documents for category 5.13. Objectives and basis for R&D4. Self-Assessment Report5. Information of Marketing Authorization Holder6. Information of original drug7. Draft of packaging insert, note to the draft, and relevant reference literature8. Specimen of the designed package and label(II) Summary of the main Studies9. Summary of pharmaceutical studies10. Summary of non-clinical studies11. Summary of clinical studies(III) Pharmaceutical studies data/documents12. (3.2.S) Drug Sunstance (3.2.S is the No. of CTD format)12.1 (3.2.S.1) General information12.2（3.2.S.2 ）Manufacture12.3（3.2.S.3 ）Characterisation12.4（3.2.S.4）Control of drug substance12.5（3.2.S.5）Reference standards or materials12.6（3.2.S.6）Container Closure System12.7（3.2.S.7）Stability13. （3.2.P） Drug Product13.1（3.2.P.1）Description and composition of the drug product13.2（3.2.P.2）Pharmaceutical development13.3（3.2.P.3）Manufacture13.4（3.2.P.4）Control of drug substance and excipients13.5（3.2.P.5）Control Drug Product13.6（3.2.P.6）Reference standards or materials13.7（3.2.P.7）Stability(IV) Nonclinical studies data/documents14.Summary of nonclinical studies15.Main pharmacology tests documents and literatures16.Safety pharmacology tests documents and literatures17.Singe-dose toxicity tests documents and literatures18.Repeat-dose toxicity tests documents and literatures19.Genotoxicity tests documents and literatures20.Reproductive toxicity tests documents and literatures21.Carcinogenicity tests documents and literatures22.Dependence tests documents and literatures23.Special safety tests documents and literatures including but not limited to hypersusceptibility (topic, pantasomatous and photosenstitive toxicity), hemocytolysis and topical topical irritation (blood vessel, skin, mucous memberbrance, muscle and etc.)24.Other safety tests documents and literatures25.Nonclinical pharmacokinetics tests documents and literatures26. Tests documents and literatures on mutual effect between pharmacology, toxicity and pharmacokinetics of the multiple ingredients in compound drug products/formulation (V) Clinical tests documents27.Summary of clinical tests documents28.Clinical tests plan and study protocol29. Data management plan, statistical analysis30.Investigator’s brochure31.Draft of informed consent form, approval of the ethics committee, review report of science committee32.Clinical tests report33. Electronic file of clinical tests data34. Report of data management, report of statistical analysis(III) Pharmaceutical studies data/documents12. (3.2.S) Drug Substance12.1 (3.2.S.1) General Information3.2.S.1.1 Name of the drugPlease provide Chinese and English generic names, chemical names, CAS numbers and other names of drug substance (including those in foreign pharmacopoeia).3.2.S.1.2 StructurePlease provide the structural formula, molecular formula, and molecular weight of Drug substance. If there are three-dimensional structures and polymorphs, it should be specified.3.2.S.1.3 Physicochemical propertiesPlease provide the physical and chemical properties of the drug substance (generally derived from pharmacopoeia and Merck index, etc.), including the following information: character (such as appearance, color, physical state); melting point or boiling point; specific rotation, solubility, solution pH, Partition coefficient, dissociation constant, physical form (such as polymorph, solvate, or hydrate) that will be used for preparation production, particle size, etc..12.2(3.2.S.2) Manufacture3.2.S.2.1 ManufacturerPlease provide the manufacturer's name (full name), address, telephone number, fax number, and the address of the production site (specifically to the plant/shop, production line), telephone, fax, etc.3.2.S.2.2 Manufacturing process and control(1) Flow chart: A flow chart is provided according to the process steps, indicating the process parameters and the solvent used. For chemically synthesized drug substance, it should also provide its chemical reaction formula, which should include the starting materials, intermediates, molecule formula/molecule weight/structure of the reagents.(2) Description of the manufacture process: The process operation is described by the process flow, represented by the registered batch. The amounts of each reaction material and the yieldrange of each step are listed, and the key production steps, key process parameters and quality control indicators of the intermediates are clarified.(3) Equipments: Please provide the information of the main and special equipments (such as type, technical parameters, common batch size range, manufacturer, the reaction steps used).(4) Indicate the batch size range of commercial batches.The detailed degree of production process description should enable the technicians of this specialty to completely repeat the production process according to the declared production process and produce products that meet the standards.3.2.S.2.3 Control of materialsAccording to the process in the process flow chart, all the materials used in the production (such as starting materials, reagents, solvents, catalysts, etc.) are listed in the form of a table, and the steps used are explained. An example is as follows:Table 1(Note: serial number, the same below): material control informationPlease provide quality control information for the above materials, specify reference standards, or provide internal control standards (including items, testing methods and limits), and provide necessary methodological verification data.For the key starting materials, the preparation process data should be provided according to the relevant technical guidelines and technical requirements.3.2.S.2.4 Control of critical step & intermediateList all key steps (including final product refining and purification process steps) and control range of process parameters.List the quality control standards for isolated intermediates, including items, methods and limits, and provide necessary methodological verification data.3.2.S.2.5 Evaluation and validation of the manufacture processProcess validation data, including process validation protocol and validation report, should be provided for sterile drug substance. For other drug substance, only process validation protocols and batch production record samples can be provided, but the commitment to validate the first three batches of commercial production batches after approval should be submitted at the same time. Validation protocol, validation report, batch production record should be numbered, and should be signed by appropriate personnel (such as QA, QC, quality and production manager, etc.).3.2.S.2.6 Manufacturing process developmentProvide the selection basis of the manufacture process (including literature basis and theory basis).Detailed research data (including research methods, research results and research conclusions) are provided to illustrate the rationality of key steps determination and the rationality of process parameters control range.The main changes of production process in the process of process development (including batch, equipment, process parameters and process routes) and related supporting validation research data are described in detail.A summary table of process research data is provided. An example is as follows:Table XX: A summary table of process research datavalidation/stability studies;2:Explain whether the production process of the batches listed in the table is consistent with the process under S.2.2. If they are inconsistent,the differences should be clarified.12.3 (3.2.S.3.) Characterizations3.2.S.3.1 Structure and physiochemical properties(1) Confirmation of the structureThe structure of the product is analyzed by combining the synthetic route and various structural confirmation methods. If it may contain three-dimensional structure, crystalline water/crystalline solvent or polycrystalline form, it should be explained in detail.Provide the method of purification, purity, batch number of the sample for structural confirmation. If the reference substance is used, the source, purity and batch number of the reference substance should be explained; specific research data and spectra are provided and analyzed. For specific requirements, please refer to the Technical Guidelines for the Preparation and Structural Confirmation of Drug substance of Chemical Drugs.(2) Physicochemical propertiesProvide detailed physicochemical information, including: character (such as appearance, color, physical state); melting point or boiling point; specific rotation, solubility, hygroscopicity, solution pH, partition coefficient, dissociation constant, physical morphology (such as polycrystalline, solvents or hydrates) to be used in preparation production, particle size, etc3.2.S.3.2 ImpuritiesList the possible impurities (including organic impurities, inorganic impurities, residual solvents and catalysts) in the product, analyze the sources of impurities (from synthetic raw materials, by-products produced in the production process or from degradation), and provide control limits. An example is as follows:Table XX:Analysis of ImpuritiesThe degradation products can be explained by accelerated stability test and forced degradation test, and the basis for controlling the final quality standard and the limit of control should be provided.For known impurities, preparation, structural confirmation and other information are required.The possible genotoxic impurities were analyzed, studied and controlled in combination with the starting materials and the preparation process of the product.12.4 (3.2.S.4) Quality control of drug substance3.2.S.4.1 Quality standardProvide the quality standard according to the following table. If the method and limit of release standard and shelf life standard are different, they should be explained separately.Table XX: Quality standard of drug substance3.2.S.4.2 Analytical methodProvide specific testing methods for each item in the quality standard.3.2.S.4.3 Validation of analytical methodProvide methodological verification data according to the Technical Guidelines for the Validation of Analytical Methods for Chemical Drug Quality Control, the Technical Guidelines for the Standardization of Chemical Drug Quality Standards, the Technical Guidelines for the Study of Chemical Drug Impurities, the Technical Guidelines for the Study of Residual Solvents for Chemical Drug and the relevant Guidelines in the Appendix to the Current Pharmacopoeia ofthe People's Republic of China. The data can be provided item by item according to the testing method, and the verification results can be compiled in tabular form, and the relevant verification data and spectra can be provided. An example is as follows:Table XX:Summary of methodological validation of assay3.2.S.4.4 Batch analysis reportProvide analysis reports for at least three batches of samples.3.2.S.4.5 Justification of quality standardExplain the considerations of item setting, summarize and analyze the basis of selection of analysis methods and determination of limits.If the domestic and foreign pharmacopoeia has been published,compare them together.12.5 (3.2.S.5) Reference standards or materialsIf the Pharmacopoeia reference substance is used in the drug development process, the source should be stated and the instructions and batch number should be provided.If a self-made reference is used during the development of the drug, the calibrating process of the assay and purity should be provided.12.6 (3.2.S.6) Packaging materials and containers(1)Type of packaging materials, source and relevant certificate documents:Table XX: Type of packaging materials, source and relevant certificate documentsspecified.For example, composite film bag packaging consists of: polyester/aluminum/polyethylene composite film bag, polyester/low-density polyethylene composite film bag.Provide the analysis report of packaging materials (from manufacturer of packaging material or supplier).(2)Explain the basis for selection of packaging materials.(3)Supportive studies conducted on selected packaging materials.12.7 (3.2.S.7) Stability3.2.S.7.1 Stability SummarySummarize the sample conditions, investigation conditions, investigation indicators and investigation results of the stability study conducted, analyze the trend of change, and propose storage conditions and expiration dates. The above information can be provided in tabular form, which can be referred to the data under preparations.3.2.S.7.2 Post-approval commitment and protocol of the stabilityIt is promised to conduct long-term sample stability investigation on the first three batches of products produced after approval, and conduct long-term sample stability investigation on at least one batch of products produced each year. If there are any abnormalities, the management authority should be notified in time.Follow-up stability study protocol should be provided.3.2.S.7.3 Stability dataProvide detailed documents of the stability studies in tabular form. The spectra can be submitted as annex. The requirements of chromatographic data and spectra are referred to the materials under the preparations.。