药品注册英文
Glossary（术语）：
Regulatory Affairs （RA）：药政事务
drug authority：药政当局
investigation and research before project approval：立项前的调研Market Authorization （MA）：上市许可
post-approval commitment study：上市后的承诺研究
post-approval variation application：补充申请
life cycle：生命周期
Chemistry, Manufacturing, and Controls （CMC）：药品的化学、生产和控制
cross-functional teams：公司内部各部门
look at the big picture：从大局考虑
think strategically：进行战略性思考
risks and benefits：风险和获益
Food and Drug Administration （FDA）：美国食品药品监督管理局European Medicines Agency （EMA）：欧洲药品管理局International Multi-center Clinical Trial （IMCT）：国际多中心临床试验
Bioequivalence study （BE study）：生物等效性试验
generic drug：仿制药
Center for Drug Evaluation （CDE）：SFDA下属的药品审评中心Quality by Design （QbD）：质量源于设计
CMC Pilot Program：FDA在业内开展的关于QbD的试点研究
early launch：早日上市
design space：设计空间
Business Development （BD）：业务发展部门
Imported Drug License （IDL）：进口药品注册证
Manufacturing License （ML）：生产许可证
Clinical Trial Permission （CTP）：临床试验批件
Active Pharmaceutical Ingredient （API）：原料药
Orange Book：橙皮书
business value：商业价值
the Pharmacopoeia of the People's Republic of China（ChP）：中国药典the United States Pharmacopoeia （USP）：美国药典
the European Pharmacopoeia （Ph. Eur.或EP）：欧洲药典
List of Essential Drugs （EDL）：基本药物目录
Reimbursement Drug List （RDL）：医保目录）
typing error：打印错误
slip of the pen：笔误
Drug Master File （DMF）：药物主文件
Certificate of Analysis （CoA）：检验报告
Marketing （MKT）：市场部
market share：市场占有率
sales volume：销量
investigator brochure （IB）：研究者手册
protocol：临床试验方案
priority：优先度
package insert （PI）：说明书
labeling：包装标签
Patient Information Leaflet （PIL）：患者使用的说明书
Summary of Product Characteristics （SmPC，SPC）：产品特性摘要foil：铝箔
carton：装药品的小盒
shipping label：运输包装标签
Medical：医学部
provincial drug administration （PDA）：省级药监局，包括省、自治区和直辖市药品监督管理部门
Institute for Food and Drug Control：药检所
National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”supplementary dossier：补充资料
approval letter：注册批件
out of specification （OOS）：超出标准、不合格
adverse effect （AE）：不良事件
trial waiver：减免临床试验
Clinical：临床部门
Commercial：商业部门
new chemical entity （NCE）：新化学实体
key opinion leader （KOL）：关键意见领袖
off-label use：标签外使用
patient pool：患者库
deadline：最后期限
global trial：全球性的临床试验，即国际多中心临床试验regional trial：区域性的临床试验
TPD 加拿大卫生部治疗产品局
adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学。
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 suitability to monograph of European 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：Drug master 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 Master File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：Active Pharmaceutical Ingredient 原料药Dossier：文档，档案。
TSE：Transmitting animal Spongiform Encephalopathy 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。
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。
常用药品监管词汇中英文
1. 《中华人民共和国药品管理法》Drug Control Law of the People's Republic of China 2.药品生产企业管理control over drug manufacturers3.药品经营企业管理control over drug distributors4.医疗机构的药剂管理control over medicines in medical institutions5.药品管理control over drugs6.药品包装的管理control over drug packaging7.药品价格和广告的管理control over drug price and advertisement8.药品监督inspection of drugs9.法律责任legal liabilities10.药品标识labels or marks of the drugs11.假药counterfeit drugs12.劣药inferior drugs13.药品检验机构drug quality control laboratory14.药品的生产企业drug manufacturers15.经营企业drug distributors16.医疗机构medical institutions17.药品监督管理部门drug regulatory agency18.药品批准证明文件drug approval documents19.行政处分administrative sanctions20.刑事责任criminal liabilities21.药品生产质量管理规范Good Manufacturing Practice for Pharmaceutical Products (GMP)22.药品经营质量管理规范Good Supply Practice for Pharmaceutical Products (GSP)23.药品生产许可证Drug Manufacturing Certificate24.药品经营许可证Drug Supply Certificate25.医疗机构制剂许可证Pharmaceutical Preparation Certificate for Medical Institution26.进口药品注册证书Import Drug License27.临床试验clinical trial28.新药证书New Drug Certificate29.药品批准文号Drug Approval Number30.在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人，必须遵守《中华人民共和国药品管理法》All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the people's republic of China.31.国务院药品监督管理部门主管全国药品监督管理工作。
药品注册英文
药品注册英文公司标准化编码 [QQX96QT-XQQB89Q8-NQQJ6Q8-MQM9N]Glossary（术语）：Regulatory Affairs （RA）：药政事务drug authority：药政当局investigation and research before project approval：立项前的调研Market Authorization （MA）：上市许可post-approval commitment study：上市后的承诺研究post-approval variation application：补充申请life cycle：生命周期Chemistry, Manufacturing, and Controls （CMC）：药品的化学、生产和控制cross-functional teams：公司内部各部门look at the big picture：从大局考虑think strategically：进行战略性思考risks and benefits：风险和获益Food and Drug Administration （FDA）：美国食品药品监督管理局European Medicines Agency （EMA）：欧洲药品管理局International Multi-center Clinical Trial （IMCT）：国际多中心临床试验Bioequivalence study （BE study）：生物等效性试验generic drug：仿制药Center for Drug Evaluation （CDE）：SFDA下属的药品审评中心Quality by Design （QbD）：质量源于设计CMC Pilot Program：FDA在业内开展的关于QbD的试点研究early launch：早日上市design space：设计空间Business Development （BD）：业务发展部门Imported Drug License （IDL）：进口药品注册证Manufacturing License （ML）：生产许可证Clinical Trial Permission （CTP）：临床试验批件Active Pharmaceutical Ingredient （API）：原料药Orange Book：橙皮书business value：商业价值the Pharmacopoeia of the People's Republic of China （ChP）：中国药典the United States Pharmacopoeia （USP）：美国药典the European Pharmacopoeia （Ph. Eur.或EP）：欧洲药典List of Essential Drugs （EDL）：基本药物目录Reimbursement Drug List （RDL）：医保目录）typing error：打印错误slip of the pen：笔误Drug Master File （DMF）：药物主文件Certificate of Analysis （CoA）：检验报告Marketing （MKT）：市场部market share：市场占有率sales volume：销量investigator brochure （IB）：研究者手册protocol：临床试验方案priority：优先度package insert （PI）：说明书labeling：包装标签Patient Information Leaflet （PIL）：患者使用的说明书Summary of Product Characteristics （SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒shipping label：运输包装标签Medical：医学部provincial drug administration （PDA）：省级药监局，包括省、自治区和直辖市药品监督管理部门Institute for Food and Drug Control：药检所National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”supplementary dossier：补充资料approval letter：注册批件out of specification （OOS）：超出标准、不合格adverse effect （AE）：不良事件trial waiver：减免临床试验Clinical：临床部门Commercial：商业部门new chemical entity （NCE）：新化学实体key opinion leader （KOL）：关键意见领袖off-label use：标签外使用patient pool：患者库deadline：最后期限global trial：全球性的临床试验，即国际多中心临床试验regional trial：区域性的临床试验TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学。
药品注册英文
Glossary（术语）：Regulatory Affairs （RA）：药政事务drug authority：药政当局investigation and research before project approval：立项前的调研Market Authorization （ MA ）：上市许可post-approval commitment study：上市后的承诺研究post-approval variation application：补充申请life cycle ：生命周期Chemistry, Manufacturing, and Controls （ CMC）：药品的化学、生产和控制cross-functional teams：公司内部各部门look at the big picture：从大局考虑think strategically：进行战略性思考risks and benefits：风险和获益Food and Drug Administration （FDA）：美国食品药品监督管理局European Medicines Agency （EMA ）：欧洲药品管理局International Multi-center Clinical Trial （IMCT ）：国际多中心临床试验Bioequivalence study （ BE study）：生物等效性试验generic drug：仿制药Center for Drug Evaluation （CDE）：SFDA 下属的药品审评中心Quality by Design （QbD）：质量源于设计CMC Pilot Program：FDA 在业内开展的关于QbD 的试点研究early launch：早日上市design space：设计空间Business Development （BD）：业务发展部门Imported Drug License （IDL ）：进口药品注册证Manufacturing License （ ML ）：生产许可证Clinical Trial Permission （CTP）：临床试验批件Active Pharmaceutical Ingredient （API ）：原料药Orange Book：橙皮书business value：商业价值the Pharmacopoeia of the People's Republic of China（ChP）：中国药典the United States Pharmacopoeia（USP）：美国药典the European Pharmacopoeia（Ph. Eur.或 EP）：欧洲药典List of Essential Drugs （EDL ）：基本药物目录Reimbursement Drug List （RDL）：医保目录）typing error：打印错误slip of the pen：笔误Drug Master File （DMF ）：药物主文件Certificate of Analysis （CoA ）：检验报告Marketing （MKT ）：市场部market share：市场占有率sales volume：销量investigator brochure （IB ）：研究者手册protocol：临床试验方案priority ：优先度package insert （PI）：说明书labeling：包装标签Patient Information Leaflet （PIL ）：患者使用的说明书Summary of Product Characteristics （SmPC，SPC）：产品特性摘要foil ：铝箔carton：装药品的小盒shipping label：运输包装标签Medical：医学部provincial drug administration （PDA）：省级药监局，包括省、自治区和直辖市药品监督管理部门Institute for Food and Drug Control：药检所National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”supplementary dossier：补充资料approval letter：注册批件out of specification （OOS）：超出标准、不合格adverse effect （AE）：不良事件trial waiver ：减免临床试验Clinical ：临床部门Commercial：商业部门new chemical entity （NCE）：新化学实体key opinion leader （KOL ）：关键意见领袖off-label use：标签外使用patient pool：患者库deadline：最后期限global trial ：全球性的临床试验，即国际多中心临床试验regional trial：区域性的临床试验TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学他们继续往前走。
药品注册英文
Glossary（术语）：RegulatoryAffairs（RA）：药政事务drugauthority：药政当局investigationandresearchbeforeprojectapproval：立项前的调研FoodandDrugAdministration（FDA）：美国食品药品监督管理局EuropeanMedicinesAgency（EMA）：欧洲药品管理局InternationalMulti-centerClinicalTrial（IMCT）：国际多中心临床试验Bioequivalencestudy（BEstudy）：生物等效性试验genericdrug：仿制药CenterforDrugEvaluation（CDE）：SFDA下属的药品审评中心QualitybyDesign（QbD）：质量源于设计businessvalue：商业价值thePharmacopoeiaofthePeople'sRepublicofChina（ChP）：中国药典theUnitedStatesPharmacopoeia（USP）：美国药典theEuropeanPharmacopoeia（Ph.Eur.或EP）：欧洲药典ListofEssentialDrugs（EDL）：基本药物目录ReimbursementDrugList（RDL）：医保目录）typingerror：打印错误slipofthepen：笔误labeling：包装标签PatientInformationLeaflet（PIL）：患者使用的说明书SummaryofProductCharacteristics（SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒shippinglabel：运输包装标签Medical：医学部provincialdrugadministration（PDA）：省级药监局，包括省、自治区和直辖市药（Commercial：商业部门newchemicalentity（NCE）：新化学实体keyopinionleader（KOL）：关键意见领袖off-labeluse：标签外使用patientpool：患者库deadline：最后期限globaltrial：全球性的临床试验，即国际多中心临床试验。
原料药国际注册
Issue Date Issue Date 24/10/2012 21/02/2006 17/03/2015 23/01/2008
Status Status VALID WITHDRAWN BY HOLDER VALID WITHDate
Type Type Chemistry
基于保密原则，无任何信息公布 年度数量统计 /Drugs/DevelopmentApprovalProcess/H owDrugsareDevelopedandApproved/DrugandBiologicAppro valReports/INDActivityReports/default.htm
/scripts/inspsearch/
ORA：Office of Regulatory Affairs
483报告：仅部分可见 /AboutFDA/CentersOffice s/OfficeofGlobalRegulatoryOperationsandPol icy/ORA/ORAElectronicReadingRoom/default .htm
US 药品注册——New Drug Application (NDA)
Approval Letter NDA涉及场地的现场审查
GMP/cGMP
NAI No Action Indicated VAI Voluntary Action Indicated OAI Official Action Indicated /scripts/inspsearch/ 483： /AboutFDA /CentersOffices/OfficeofGlobal RegulatoryOperationsandPolicy /ORA/ORAElectronicReadingRo om/default.htm
药品注册的英文面试介绍
药品注册的英文面试介绍Title: Introduction to Drug Registration in English.Drug registration is a crucial process that pharmaceutical companies must undergo in order to bring their products to the market. It involves the submission of extensive documentation and data to regulatory authorities to demonstrate the safety, efficacy, and quality of the drug. In this article, we will provide an overview of the drug registration process and its importance in ensuring the availability of safe and effective medications for the public.The drug registration process typically begins with the compilation of a comprehensive dossier containing detailed information about the drug, including its chemical composition, manufacturing process, preclinical andclinical data, and proposed labeling. This dossier serves as the basis for the regulatory authority's evaluation of the drug's safety and efficacy.Once the dossier is submitted, regulatory authorities conduct a thorough review of the data to assess the drug's compliance with their standards and guidelines. This review process may involve the evaluation of clinical trial results, pharmacokinetic and pharmacodynamic studies, and toxicology data to determine the drug's safety profile and potential risks.In addition to safety and efficacy considerations, regulatory authorities also assess the quality of the drug, including its formulation, stability, and packaging. They may conduct inspections of manufacturing facilities to ensure that the drug is produced in accordance with good manufacturing practices (GMP) and meets quality standards.The drug registration process is essential for protecting public health and ensuring that only safe and effective medications are available to patients. By requiring pharmaceutical companies to provide comprehensive data and evidence of a drug's safety and efficacy, regulatory authorities are able to make informed decisionsabout its approval for marketing and use.In conclusion, drug registration is a critical step in the development and commercialization of pharmaceutical products. It involves the submission of extensive documentation and data to regulatory authorities to demonstrate the safety, efficacy, and quality of the drug. By ensuring that only safe and effective medications are available to the public, the drug registration process plays a vital role in safeguarding public health.。
药品注册管理办法-英文版
DRUG REGISTRATION REGULATION(SFDA Order 28)(Translation by RDPAC, for Member use only)Drug Registration Regulation was approved on June 18, 2007 by SFDA executive meeting and is hereby published, which become effective from October 1, 2007.SFDA CommissionerShao MinliJuly 10, 2007 DRUG REGISTRATION REGULATIONChapter 1: General PrinciplesArticle 1:This Regulation is promulgated according to the Drug Administration Law of T he People’s Republic of China (Drug Administration Law), Administrative Licensing Law of T he People’s Republic of China(Administrative Licensing Law), and the Implementing Regulation of the Drug Administration Law of T he People’s Republic of China (Implementing Regulation) to ensure the safety, efficacy and quality control of drugs and standardize drug registration. Article 2:This Regulation shall apply to all drug research and clinical studies, application for clinical study, drug production and / or importation, as well as the drug approval review, registration inspection and drug administration in The People’s Republic of China (PRC).Article 3:Drug registration means the legal process by which a decision is made by SFDA, upon application of registration applicant, to either approve or not approve the conducting of a drug clinical trial, production or importation of a drug to be marketed, based on a systematic evaluation of the safety, efficacy and quality control of the drug.Article 4:The State shall encourage research and development of new drugs and exercise the approval via a special process of innovative new drugs, those for difficult to treat and life threatening diseases.Article 5:The State Food and Drug Administration (SFDA) is thecompetent national authority for drug registration, responsible for the review and approval of clinical studies, production and importation of drugs.Article 6:Drug registration should follow the principles of openness equality, fairness, and for the convenience of the publics.During drug registration, SFDA shall apply the systems of joint responsibility of the presiding reviewer, public disclosure and rescuing of the related staff, responsibility investigation for any wrongdoing, in order to administer the steps from acceptance, inspection, review, approval, through delivery, and subject to monitoring by the publics.Article 7:During drug registration, should the drug administrative authority consider any permitting issues of significant interest to the publics, the issues should be announced to the publics and public hearing should be held.Should the administrative permitting be related to any significant interest between applicant and other parties, before any decision is made, drug administration authorities should notify applicant and other parties of their entitlement to requesting hearings, statement and defending.Article 8:Drug administration authorities shall provide applicant with accessible information regarding drug registration acceptance, inspection, test, evaluation, approval progress and conclusion and so on.Drug administration authorities should publicly disclose the following information at the official website and / or office location.1.Drug registration application items, procedure, fee standards andbasis, timeline, table of content of all required dossier, as well as reference application documents. list and the related information of the staff at each steps fromacceptance, inspection, test, review, through approval.3.general information of drug registration such as formulary of theapproved drugs.Article 9:The drug administration authority, units and staffs involved shall assume the responsibility of protecting the technical secrets and data provided by applicants during the process of drug registration.Chapter 2: Basic RequirementsArticle 10: A drug registration applicant (applicant) means an institution that makes drug application and assumes corresponding liability for drugregistration.A local applicant shall be a legally registered institution in China and be competent to independently assume legal liability. A foreign applicant shall be a legally established pharmaceutical company outside of China. In making application for an imported drug registration, the foreign applicant shall use its office in China, or authorize an agent in China to handle the application.The person(s) handling the drug registration application shall have technical expertise, and be familiar with drug administration laws, regulations and technical requirements.Article 11:Drug registration application includes application for new drug, generic drug applications, application for imported drug, supplemental application, as well as re-registration application.A local applicant shall make application according to new drug or generic drug applications; a foreign applicant shall make application according to imported drug.Article 12: A new drug application means a registration application for a drug that has not been marketed in China.Applications made for a change in dosage form, or route of administration, additional new indication of drugs shall be made according to new drug registration procedure.Generic drug application means application for registration of a drug for which SFDA has already issued formal standards, however, application of biological products shall be follow new drug application.Application for imported drug means application for a drug produced outside China to be marketed in China.Supplemental application means an application for the change, addition, or cancellation of any item or contents in the existing registration approval of a new drug, generic drug applications, or imported drug.A re-registration application means the application to continue the drug production or importation after the expiry of the certified drug approval documents.Article 13:Applicants should provide sufficient and reliable research data to evidence the safety, effectiveness and quality control of the drugs, and assume liability of the truthfulness of the entire dossier.Article 14:In citing literature and materials, the name of the work(s) and journal(s) as well as volume, issue and page number shall be provided in theapplication dossier submitted for drug registration. For unpublished literature and materials, an authorization letter from the owner must be provided. For any foreign language materials a Chinese translation should be provided in accordance with relevant requirements.Article 15:SFDA shall implement the National pharmaceutical industry development plan and policy, and may organize an assessment of the benefit of introduction of drugs to the market.Article 16:During drug registration, drug administration authorities should conduct on site inspection and inspection chosen from decision of the pre-clinical study and clinical trials, as well as conduct on site inspection of production site prior to any marketing approval, in order to confirm the truthfulness, accuracy and completeness of the application dossier.Article 17:If two or more institutions jointly apply for drug registration, the application shall be made to the PDA where the drug manufacturer is located. If all the applicants are manufacturers, the application shall be made to the PDA where the drug manufacturer of the preparation is located. If none of the applicants is a drug manufacturer, the application shall be made to the PDA where the drug sample is pilot manufactured.Article 18:Regarding the drug or its formula, production process, indication etc., the applicant shall submit documents explaining the China patent status and ownership rights. If other party holds patent in China, the applicant shall submit a letter stating that the drug will not infringe on the patent rights of others. Upon acceptance of the application, drug administration authorities should publicly disclose the statement submitted by applicant.If an infringement dispute occurs during registration application, the parties shall resolve the matter according to relevant laws for patent administration. Article 19:For a drug that has obtained patent protection in China, another applicant may apply for registration within two years prior to the patent expiration. SFDA shall review the application according to this Regulation and, after expiration of the patent, issue a drug approval number, Imported Drug License or Drug Product License, for an application that meets requirements.Article 20: According to Article 35 of Implementation Regulation, for a period of 6 years from the date of the original applicant's approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed R&D data and other data generated by the original applicant for submission of application ofmanufacturing or marketing of a drug containing new chemical ingredients, unless the submitted data is generated by the subsequent applicant itself. Article 21:The scope of pre-clinical laboratory study (pre-clinical study) of a drug for registration includes synthetic process, extraction methods, physical-chemical properties and purity, dosage form selection, screening of formulas, preparation process, inspection methods, quality specification, stability, pharmacology, toxicology and pharmacokinetic study. For TCM preparations, information such as the source and the processing of raw materials should also be included. For biological products, information such as source, quality standards, storage condition, biological identity, genetic stability and immunology study of strain, cell strain as well as biological tissue should also be included.Article 22:Pre-clinical study of a drug shall be conducted in accordance with relevant regulations, where the drug safety evaluation must be conducted in accordance with Good Laboratory Practice for Pre-Clinical Laboratory Studies (GLP).Article 23:Institutions engaged in drug research and development shall have the necessary personnel, facility, equipment, instruments, conditions and management system needed corresponding to the research project, and shall guarantee the authenticity of all data and materials. The animals, reagents and raw materials used for experiments shall comply with relevant national regulations and requirements.Article 24:If an applicant authorizes another institution to conduct the study of drugs, or any single experiment, inspection or pilot production and manufacture, the applicant shall sign a contract with the authorized party, and make notes in the application dossier. The applicant is responsible for the truthfulness of the drug study data used in the application dossier. . Article 25:When an application is only made for registration of preparation, the raw materials of the investigative drug substance used for this preparation must have a Drug Approval Number, Imported Drug Certificate or Pharmaceutical Product Certificate, and must have been obtained from legal channels. Any investigative drug substance which does not have a Drug Approval Number, Imported drug Certificate or Pharmaceutical Product Certificate must be approved by SFDA.Article 26:If an applicant uses the drug study data from a foreign drug research for a drug registration application, an explanation for the study items, and referencing the page numbers issued by this institution shall be provided, and notarized certificate of the institution's legal overseas registration shall be attached. Only after the documents are authenticatedby SFDA may they be included in the registration documents. SFDA may send people to conduct on-site inspections, if necessary.Article 27: During the verification of drug studies, drug authorities may request the applicant or the drug research institute that conducted the experiments to repeat an experiment for any items by using the methods and data listed in the application dossier. SFDA may also designate other drug control institutes or drug research institutions to repeat the experiments or to validate the methodology.Article 28:Drug study shall be conducted in accordance with relevant technical guidelines issued by SFDA. If the applicant conducts the experiments according to other methods and techniques, the applicant shall provide information to evidence that the methods and techniques are scientific.Article 29:After obtaining the drug approval number, the applicant should produce the drug according to the process approved by SFDA. Drug administrations shall monitor the production according to the approved production process and standards.Chapter 3: Clinical Trials of DrugsArticle 30:Clinical study of drugs, including bioequivalence trials, must be approved by SFDA, and must be conducted in accordance with Good Clinical Practice (GCP).Drug administrations shall monitor the approved clinical studies.Article 31:Clinical trials should be conducted for the registration of a new drug. For registration application of generic drugs and supplemental application, clinical trails should be conducted in accordance with provisions specified in Appendix of this Regulation.Clinical trials are divided into Phase I, Phase II, Phase III and Phase IV. Phase I: Basic clinical pharmacology and human safety evaluation studies. To observe tolerance in human bodies and pharmacokinetics, providing a basis for a drug administration program.Phase II: A preliminary exploration on the therapeutic efficacy. The purpose is to evaluate the safety and efficacy of a new drug on patients within the target indication of the drugs, and providing the basis to devise Phase III Clinical Trial and to determine a drug administration program. Phase II Clinical Trial may be conducted in many ways includingrandomized blind controlled clinical trial in accordance with the purpose of the study.Phase III: The phase to confirm the therapeutic efficacy. The purpose is to further verify the safety and efficacy of a new drug for patients with targeted indication, to evaluate the benefit and risks relationship, and finally to provide sufficient data to support the registration approval of the drug. The trials usually are randomized, blind and controlled clinical trial with a large number of sample subjects.Phase IV: A new drug post-marketing study, conducted by the applicant. The objective is to investigate the efficacy and adverse reactions under the conditions of wide use, and to evaluate the benefit and risk relationship when used by ordinary and special groups of patients and to improve dosage of the drug.Bioequivalence trials means those human trails to determine if there is any statistical difference in absorption and absorption speed of active component between the same or different dosage form of the same drugs under the same test conditions, by using methodology of bioavailability study and with pharmacokinetic parameters.Article 32:The number of human subjects in the clinical study of a drug should be decided in accordance with the objective of the clinical trials and shall meet both the statistical requirements and the minimal cases required by this Regulation for a clinical study. For a drug used for the treatment of rare and special diseases or other special circumstances, any requirements for reduction in the number of human subjects in the clinical study or exemption should be made at the same time of clinical trial application and be approved by SFDA.Article 33:For a vaccine and other special drugs prepared during the strains selection stage, if there is indeed neither suitable animal experimental model nor a way to evaluate the efficacy of the drugs in laboratory study, application of clinical trials may made to SFDA, provided that safety of the subjects can be ensured.Article 34: After approval of a clinical study, the applicant shall select from the institutions qualified for drug clinical trial to conduct the clinical study.Article 35:The investigational drugs shall be produced in a workshop which meets GMP requirements and the production process shall be strictly in accordance with the requirements of GMP. The applicant is responsible for the drug quality of the investigational drugsArticle 36:The applicant may inspect the investigational drug itself in accordance with the drug's standards for its selected drugs for clinical trial, or authorize a drug control institute designated by this Regulation to conduct the quality test. Vaccine, blood products and other bio-products designated by SFDA must be inspected by a drug control institute designated by SFDA.The drug must not be used for Clinical Trails before it has passed the inspection.Drug administration authorities may conduct a random inspection for the investigational drug.Article 37:Before conducting the clinical study, the applicant shall file with SFDA information such as the clinical study protocol, name of the principle investigator of the leading institution, participating institutions and investigators, approval letter from ethics committee, and the sample of the Informed Consent Form, also providing a copy to the PDA where the institutions are located and PDA where the application was filed.Article 38: If an applicant discovers that an institution conducting clinical study is in violation of relevant regulations, or is not following the clinical study protocol, the applicant shall try to have the situation corrected. For serious violation, the applicant may request to suspend or stop the clinical study and shall submit a written report to SFDA and the relevant PDA. Article 39:Upon the completion of the clinical study, the applicant shall submit a clinical study summary report, statistical analysis report, and database to SFDA.Article 40: A clinical study shall start within 3 years of approval. Otherwise the approval certificate shall automatically become null and void.A re-application shall be submitted to resume the study.Article 41:Should any serious adverse event occur during clinical trails, the institutions should report to PDA, SFDA, as well as the applicant within 24 hours of occurrence, and timely report to the Ethics Committee. Article 42:SFDA may request the applicant to amend the clinical study protocol, suspend or stop the clinical study in any of the following circumstances:1)the Ethics Committee has failed to perform its duty; or;2)the safety of the subjects cannot be effectively ensured;3)serious adverse event was not timely reported;4)evidence that the investigative drug is not effective;5)quality problems in the drug used for clinical trials;6)fraud in the clinical study;7)other circumstances violating GCP.Article 43:During the clinical study, in case a large range or unexpected adverse reaction or serious adverse event occurs, or there is evidence to prove that the investigational drug has significant quality problems, SFDA or PDA may adopt emergency mandatory administrative measures to suspend or stop the clinical study, and the applicant and institutions must immediately stop the study.Article 44: A foreign applicant who wants to conduct an international multi–center clinical study shall apply at SFDA in accordance with the following provisions:1)The investigational drug used for an international multi–center clinicalstudy shall be one already registered in a foreign country or in phase II or phase III clinical trials. An application for an international multi–center clinical study of new preventive vaccine from a foreign applicant still not registered outside China shall not be accepted by SFDA.2)In approving an international multi–center clinical study in China, SFDAmay request the applicant to firstly conduct the Phase I clinical trials in China.3)During a study conducted in China, the Applicant shall, in accordancewith the relevant regulations, report to SFDA any serious adverse events or unexpected adverse events which occur in any countries.4)Upon the completion of the study, the Applicant shall submit thecomplete clinical study report to SFDA.5)Data generated from an international multi–center clinical trial, if usedfor drug registration in China, shall be in accordance with the relevant provision of this Regulation, and the applicant shall submit the complete research information of the study.Chapter 4: Application and Approval of New Drugs Article 45:SFDA may use special approval process for the following new drug, where detail regulation will be promulgated separately:1)New drug material and its preparation, active ingredients and itspreparation extracted from plant, animal and minerals, which have not been marketed in China and;2)chemical drug raw material and its preparations, and/or biologicalproduct that have not been marketed domestically or outside China;3)new drugs for AIDS, cancer and orphan disease that are superior to themarketed drugs.4)new drugs which treat diseases for which there is no effective therapy. For those drugs meeting the above provisions of this Regulation, during the drug registration, the applicant may apply for a special approval, SFDA shall organize specialist meeting to decide whether to use special approval for the drug application.Detailed provisions of special approval shall be promulgated separately. Article 46:When a new drug is jointly developed, the application shall be made by one of the parties, and other parties shall not apply in repetition. When a joint application needs to be made, the application shall be signed by all the parties. After approval, all the new drugs, including different strengths of the same drugs shall only be manufactured by one party. Article 47:For those registration applications of change in dosage form of drug but with no change in route of administration, new technology should be used to improve drug quality and safety, and there should be obvious clinical advantage in comparing with original dosage form. Except for targeted delivery preparation, sustained or controlled release preparation, the registration applications of change in dosage form of drug but with no change in route of administration should be made by the company with production condition.Article 48:During review process of new drug, even if the marketing approval of other drug of the same active substance is approved overseas, the registration category and technical requirements of the drug shall remain unchanged in the review process in China.During the review process of new drug, even when the marketing approval of other domestic drug of the same active substance is approved in China, the registration category and technical requirements of the same kind of drug shall remain unchanged in the review process in China.Article 49:Drug applicanion dossier should be submitted in one time, the applicant shall not self submit supplemental technical material to SFDA once any application is accepted, except for new information related to the drug safety or those special approval. If applicant considers the new technical materials must be added, the applicant should withdraw the application. When an applicant re-apply, the application procedures of this regulation should be met and there should not be any same drugs already entering into monitoring period..Section 1: Clinical Trials for New DrugsArticle 50:Upon the completion of the pre-clinical study, the applicant shall complete the Application Form for Registration of New Drugs, and submit the authentic dossier to the local PDA.Article 51:PDA shall examine the format of the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of non-acceptance notification of drug registration application, with explanation of reasons.Article 52:PDA shall, within 5 days upon acceptance of the application, organize and conduct on-site inspection of the drug research and the original data, conduct preliminary examination of the application dossier. If the drug to be registered is biological product, PAD shall take sample drugs of 3 batches, and notify the drug control institute for inspection.Article 53:PDA should, within the prescribed time limit, submit the examination recommendation, verification report and application dossier to the Center of Drug Evaluation of SFDA, and notify the applicant.Article 54:Drug control institute received the registration inspection notification should inspect the sample according to the drug standards submitted by the applicant, verify the drug standards, and submit the inspection report to Center of Drug Evaluation (CDE) of SFDA within the prescribed time limit, and copy applicant in.Article 55:Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary. After completing the technical examination, technical examination recommendation will be issued and submitted to SFDA along with the related application information.SFDA shall make approval decision based on the technical examination recommendation. When SFDA consider the requirements are met, Approval for Drug Clinical Study will be issued. When SFDA does not consider the requirements are met, Notification of Approval Opinion will be issued with explanation.Section 2: Production of New DrugArticle 56:After completion of a clinical study, the applicant shall fill out the Drug Registration Form, and submit production application dossier to the PDA where the applicant is located. At the same time, the applicant shall submit the raw material and research data related to standard substance for the preparation of the standard substance to NICPBP.Article 57:PDA shall examine for form the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of non-acceptance notification of drug registration application, with explanation of reasons.Article 58:PDA shall, within 5 days upon acceptance of the application, organize and conduct on-site inspection for the clinical trial and relevant original data, conduct preliminary review and issue examination recommendation. For those drugs other than biological product, PDA should also need to take sample of 3 batches of the drugs, and notify the drug control institute to verify the standards.PDA shall, within the prescribed time limit, submit its recommendations, inspection report and application dossier to CDE, and notify the applicant. Article 59:Drug control institute should verify the drug standards, and then submit the verification recommendation to CDE within the prescribed time limit, at the same time, copy in the PDA that issued the notification to verify, and copy the applicant in.Article 60:Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary.After the examination, if the related provisions are met, CDE shall notify the applicant to file application for on site inspection of production site, and notify the Centre for Certification Administration (CCA) of SFDA.After the examination, if the related provisions are not met, CDE shall submit the recommendation and application dossier to SFDA. SFDA shall make decision not to approve based on the technical examination recommendation, and Notification of Review Opinion will be issued with explanation.Article 61: Upon receipt of the notification of on site inspection of production site, applicant should file at CCA application for on site inspection of production site within 6 months..。
常用药品注册生产英文
缩写词API Active Pharmaceutical Ingredient原料药ANDA Abbreviated New Drug Application简化新药申请仿制药ASM The Active Substance Manufacturer原料药生产厂家ADE Adverse Drug Event药物不良事件ADR Adverse Drug Reaction药物不良反应CFDA China Food and Drug Administration中国国家食品药品监督管理局COS Certificate of Suitability欧洲药典适用性认证CTD Common Technical Documents通用技术文件COA Certificat of Analysis检验报告CDE Center for Drug Evaluation药品审评中心CMC Chemistry,Manufacture and Control化学，生产及质控CRO Contract Research Orgnization合同研究组织ChP Chinese Pharmacopoeia中国药典CAS Chemical Abstracts Service美国化学文摘社CTA Clinical Trail Application临床试验申请CMO Cheif Medical Officer首席医学官CPP Certificate of a Pharmaceutical Product药品证明文书CAPA Corrective and Preventive Action纠正预防行动DMF Drug Master File药品主文件EDMF European Drug Master File欧洲药物管理档案EMEA European Agency for the Evaluation of Medicinal Product欧洲药物评审局EU European Union欧洲联盟EP European Pharmacopoeia欧洲药典FDA Food and Drug Administration食品药品监督管理局（美国药监局）GMP Good Manufacturing Practices良好生产规范HPLC High Performance Liquid Chromatography高效液相ICH International Conference of Harmonization国际协调会议IND Investigational New Drug Application新药临床试验申请IDL Import Drug License进口药品注册证书INN International Nonproprietaty Name国际非专有名称LA Letter of Authorization委托书LOQ Limit of Quantity定量限LOD Limit of Detection检测限MA Marketing Authorization上市许可NDA New Drug Application新药生产上市申请NIFDC National Institutes for Food and Drug Control中国食品药品检定研究院NMT Not More Than不大于NA Not Analysis未检测OTC Over The Counter非处方药OOS Out of Specification不合格PSUR Periodic Safety Update Reports定期安全性报告QOS The Quality Overall Summary质量整体概述QA Qulitity Assurance质量保证QC Qulitity Control质量控制Rx Prescription Drug处方药RS Reference Standard对照品SOP Standard Operation Procedure标准操作规范TS Test Solutions指示剂UV Ultraviolet紫外分光光度法USP United States Pharmacopoeia美国药典药品注册词汇Drug registration application注册申请Supplementary application补充申请Drug regulatory department药品监管部门Re-registration application再注册On-site inspection现场核查Production site inspection生产现场核查Causal inspection有因核查Authenticity真实性Precision准确性Integrity完整性Entrusted agency代理机构Dosage form剂型Formula处方Preparing process生产工艺Testing methods检验方法Quality specifications质量指标Stability稳定性Drug approval number批准文号Method verification方法验证Manufacturer生产厂家Plant工厂Production line生产线Workshop车间Safety安全性Efficacy有效性Acceptance受理Applicant申请人Biological product生物制品Preliminary review初步审核Variation变更Raw data原始数据Specifications verification标准复核Second review复审GMP certificate生产质量管理规范证书Application dossers申请文件Center for food and drug inspection of CFDA CFDA食品药品审核查验中心产品英语部分streptococcus pneumoniae肺炎链球菌Streptococcus pyogenes酿脓性链球菌Branhamella catarrhalis卡他布兰汉姆菌staphylococcus aureus金黄色葡萄球菌Haemophilus influenzae type BB型流感嗜血杆菌Klebsiella pneumoniae肺炎克雷伯杆菌Manufacturing process生产过程Process control过程控制Lysate裂解物Culture培养培养基Ultrafiltration滤过，超滤Inactivation灭活Autolysis自溶Alkaline碱性的Bacterial strain菌株Revitalize复原，激活Sub-culture传代培养Inoculate嫁接Fermenter发酵器Cultivate培养Stir搅拌Concentrate浓缩Turbidity浑浊度Fungi真菌Elimination消除Identify鉴别Purity纯度Germ细菌，病菌Liter升Microbiological control微生物控制Thimerosal硫柳汞Sodium methyl-paraben对羟基苯甲酸甲酯钠Dose and uniformity of dose剂量及均一性Chlorhexidine diacetate乙酰乙酸氯已定Polysorbate80吐温80（聚山梨酯80）Antigenic activity抗原活性Rocket immunoeletroforesis火箭电泳法Excipient辅料Sterile distilled water无菌注射用水Purified water纯化水Appearance性状Container包装Surfactant表面活性剂Preservative防腐剂Leaflet说明书Active ingredients活性成分Approval documents批准证明文件Research data研究资料Stability稳定性Validation of method方法学验证。