正版 世界卫生组织药品标准专家委员会第48次技术报告 金少鸿,宁

1 前言

2 一般政策

2.1 全局性药品质量保证问题

2.1.1 专家委员会关于基本药物遴选和使用的更新

2.1.2 专家委员会关于生物制品标准化的更新

2.1.3 储存区的温度分布测试

2.2 国际合作

2.2.1 与国际组织和机构的共同合作

2.2.2 药典协调组织

2.2.3 人用药品注册技术要求国际协调会(ICH)

2.2.4 药品管理机构国际会议

3 质量控制——质量标准和检测

3.1 《国际药典》

3.1.1 正在讨论的药品标准

3.1.2 递交讨论或建议撤销的《国际药典》标准

3.2 药品质量标准(包括儿童药物)

3.2.1 孕产妇、新生儿、儿童和青少年药物

3.2.2 抗疟疾药品

3.2.3 抗病毒药品

3.2.4 抗结核药品

3.2.5 被忽视的热带疾病用药

3.2.6 其他抗感染药物

3.2.7 其他药物

3.3 制剂通则及检查方法文本

3.3.1 补充信息

3.3.2 试剂、供试品溶液和滴定液

3.3.3 一般政策

3.3.4 放射性药物

4 质量控制——国际标准物质(国际化学对照品和

红外对照图谱)

4.1 关于国际化学对照品的更新

4.1.1 概况

4.1.2 国际化学对照品发放程序

4.1.3 国际化学对照品委员会的报告

4.1.4 《国际药典》关于标准物质与对照图谱附录的草案

4.1.5 国际化学对照品——其他事项

4.2 国际化学对照品合作中心报告

4.2.1 年度报告

4.2.2 年度报告的更新

5 质量控制——国家实验室

5.1 外部质量保证评估计划

5.1.1 EQAAS第5期——过程6的最终报告

5.1.2 EQAAS第5期——过程7的初步报告

5.1.3 EQAAS第6期的提议

5.2 网络

5.3 质量控制实验室与微生物实验室的培训材料

6 质量保证——药品生产质量管理规范(GMP)

6.1 WHO关于GMP的更新

6.2 WHO关于GMP——验证的更新

6.3 检查员关于“保存期限”研究的一般指南

6.4 培训教材

7 质量保证——新举措

7.1 世界药典国际性会议

7.2 药典质量管理规范

7.3 FIP—WH0技术指导原则

7.4 “可疑”药物的快检技术

7.5 “假、冒、伪、劣”药品检测中的实验室功能调查

8 质量保证——药物的分销与贸易

8.1 WHO关于国际贸易中流通药品质量的认证方案

8.1.1 更新

8.1.2 给成员国的建议信函

8.2 国家供应链的监测与监督

8.2.1 项目更新

8.2.2 关于抽样和市场监测程序的建议

8.3 修订起始物料的贸易和分销质量管理规范的提议

8.3.1 药品起始物料的贸易和分销质量管理规范

8.4 采购机构

8.4.1 采购机构的质量保证体系规范

8.4.2 采购机构的评估方法

8.4.3 产品调查问卷

9 优先基本药物的认证

9.1 WH0认证项目的更新

9.1.1 进展报告

9.2 严格监管机构批准的药物制剂认证指导原则的修订

9.2.1 严格监管机构批准的药物制剂认证文件提交的

指导原则

10 活性药物成分的认证

10.1 活性药物成分认证的更新

11 质量控制实验室的认证

11.1 质量控制实验室认证的更新

11.2 WHO质量监测项目的更新

12 监管指导原则

12.1 药物警戒和“质量缺陷”报告

12.2 多来源(仿制药)制剂文件提交的指导原则：质量部分

12.3 变更通用指导原则的建议

12.4 建立可替代性注册要求的指导原则(生物等效性)

12.5 基于WH0基本药物目录的生物等效豁免清单的更新

12.6 国际参比制剂目录及可替代多来源(仿制药)制剂等效评价用参比制剂遴选指导原则的更新

13 命名法、术语和数据库

13.1 质量保证术语

13.2 国际非专利药品名称

14 其他

14.1 策略

14.1.1 相关参考文献

15 总结和建议

致谢

附录

附录1 《国际药典》——关于放射性药物的更新机制

附录2 WH0药品GMP：主要原则

附录3 药品采购机构的质量保证体系规范

附录4 采购机构质量保障体系的评估工具：检查用备忘录

附录5 严格监管机构批准的药物制剂认证文件提交的指导原则

附录6 多来源(仿制药)制剂成品申报资料提交指南：质量部分

药品标准专家委员会目标是为药品质量保证工作建立明确、独立并适用的标准和指导原则。通过全球范围内的协商以及建立国际共识的程序建立标准。

在国际药典新增20个药品标准及一般文本，新增11个国际化学对照品，下列新指导原则已经被批准并推荐使用：《国际药典》——放射性药品更新机制，WHO药品GMP：主要原则，采购机构的质量保证体系规范，基于采购机构质量保证体系规范的评估方法：审查辅助备忘录，监管机构严格批准的药物制剂认证文件提交的指导原则，多来源（仿制药）制剂文件提交的指导原则：质量部分。

Professor SABawazirSBawazir教授因紧急事务于10月15日离会。M. Hirschhorn女士作为共同主席履行主席职责。, Head of Drug Sector and Vice-President, Saudi Food and Drug Authority, Riyadh, Saudi Arabia (Chairperson) Professor TGDekker, Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, South Africa Ms NMGuerrero Rivas缺席。, Instituto Especializado de Análisis, Ciudad Universitaria Octavio Méndez Pereira, Panamá, Republic of Panama Ms MHirschhornMHirschhorn女士作为共同主席，从S. Bawazir 教授10月15日离会起，行使主席职责。, Head, Quality and Chemistry Sector, Comisión para el. Control de Calidad de Medicamentos (Drug Quality Control Commission), Montevideo, Uruguay (Co-Chairperson) Professor JHoogmartens, Professor Emeritus, Laboratorium voor Farmaceutische Analyse, Leuven, Belgium Professor SJin, Senior Professor, National Institutes for Food and Drug Control, Beijing, People's Republic of China Professor HGKristensen, Vedbaek, Denmark Ms GNMahlangu, Director-General, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe Dr SParra, Manager, Generic Drug Quality Division 1, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada (Rapporteur) Ms LSlamet, Technical Adviser, National Agency of Drug and Food Control, Jakarta, Indonesia Mr RTribe2,Holder, ACT, Australia Dr AJvan Zyl, Sea Point, South Africa (Rapporteur) 临时顾问 Dr Mda Luz Carvalho Soares2, Brazilian Pharmacopoeia Coordinator, Brazilian Health Surveillance Agency (ANVISA), Brasília, Brazil Dr LCargill, Director, Caribbean Regional Drug Testing Laboratory, Kingston, Jamaica Professor JBDressman, Director, Institute of Pharmaceutical Technology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany Dr XGe, Senior Analytical Scientist, Pharmaceutical Laboratory, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore Dr BLi, Deputy Director General, National Institutes for Food and Drug Control, Ministry of Public Health, Beijing, Peoples Republic of China Dr JAMolzon缺席。, Associate Director for International Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA Dr ANasiri Kapour Chali, Chemical and Pharmaceutical Assessor, Medical Products Agency, Uppsala, Sweden Mrs LPaleshnuik, Arnprior, Ontario, Canada Dr JPrakash, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Raj Nagar, Ghaziabad, India Dr J-L. Robert4, Head of Department, Service du Contrle des Médicaments, Laboratoire National de Santé, Luxembourg Dr MStuder4, Basel, Switzerland Dr JWelink, Medicines Evaluation Board, Utrecht, Netherlands 来自联合国机构的代表缺席: United Nations Development Programme, New York, NY, USA。 United Nations Children’s Fund (UNICEF) Dr PSJakobsen, Quality Assurance Specialist, UNICEF Supply Division, Copenhagen, Denmark 来自专门机构和有关组织的代表缺席: United Nations Industrial Development Organization, Vienna, Austria; World Intellectual property Organization,Geneva,Switzerland,World Bark,Washington,DC,USA;Wrod Custorns Organization,Brussels,Belgium。 The Global Fund to Fight AIDS, Tuberculosis and Malaria Dr J. Daviaud, Quality Assurance Specialist, Grant Management Support, Geneva, Switzerland International Atomic Energy Agency (IAEA) Dr U. Bhonsle, Radiopharmaceutical Scientist, Radioisotope Products and Radiation Technology Section, Division of Physical and Chemical Sciences, Department of Nuclear Sciences and Applications, Vienna, Austria World Trade Organization (WTO) Ms M. McCann, Research Associate, Intellectual Property Division, Geneva, Switzerland and Ms N. Sandepeen, Research Associate, Intellectual Property Division, Geneva, Switzerland 来自政府间组织的代表缺席: European Commission, Brussels, Belgium。 European Medicines Agency (EMA)通过语音系统参与有关议题讨论。 Dr E. Cooke, Head of International Affairs, London, England and Dr D. Cockburn, Head of Compliance, London, England Council of Europe Dr A. Lodi, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France 来自非政府组织的代表缺席： Commonwealth Pharmacists Association, London, England; International Generic Pharmaceutical Alliance, Brussels, Belgium; International Society for Pharmaceutical Engineering, Tampa, FL, USA。 European Chemical Industry Council (CEFIC)/APIC Ms P. Berger, Brussels, Belgium International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Ms C. Mendy, Manager, Regulatory Policy, Geneva, Switzerland and Ms L. Girard, Head, Global Pharmacopoeial Affairs, Novartis Group Quality, Quality Systems and Standards, Basel, Switzerland International Pharmaceutical Excipients Council (IPEC) Dr F. Milek, Chair, IPEC Europe, Brussels, Belgium International Pharmaceutical Federation (FIP) Dr L. Besanon, The Hague, Netherlands World Self-Medication Industry (WSMI) Dr G. Dziekan, Director General Designate, CIB - Immeuble A “Keynes”, Ferney-Voltaire,France and Dr R. Torano, GlaxoSmithKline, England 观察员缺席: Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland。 药典委员会缺席: Farmacopea Argentina; Farmacopéia Brasileira; Pharmacopoeia of the Peoples Republic of China; Indian Pharmacopoeia Commission; Indonesian Pharmacopoeia Commission; Committee of the Japanese Pharmacopoeia; Pharmacopoeia of the Republic of Korea。 British Pharmacopoeia Commission Mrs MVallender, Editor-in-Chief, BP and Laboratory Services, London, England and Ms HCorns, Higher Pharmacopoeial Scientist State Pharmacopoeia of the Russian Federation Dr EISakanjan, Director, Centre of Pharmacopoeia and International Cooperation, Federal State Budgetary Institution, “Scientific Centre for Expert Evaluation of Medicinal Products” (FSBI “SCEMP”), Ministry of Health of the Russian Federation and Dr KBichenova, Research Associate, FSBI “SCEMP”, Ministry of Health of the Russian Federation United States Pharmacopeia Ms ALong, Senior Vice President, Global Alliances, and Executive Secretariat, Council of Experts, Rockville, MD, USA and Dr EGonikberg, Director, Chemical Medicines, Rockville, MD, USA WHO秘书处 Health Systems and Innovation (HIS) Dr M-PKieny, Assistant Director-General Essential Medicines and Health Products (HIS/EMP) Mr Cde Joncheere, Director, Essential Medicines and Health Products (EMP) Dr DJWood, Coordinator, Technologies, Standards and Norms (EMP/TSN) Quality Assurance and Safety: Medicines (EMP/QSM) Dr SKopp, Manager, Medicines Quality Assurance Programme, QSM (Secretary) Dr HSchmidt, QSM MrFJHagelstein Ms TBurkard (Intern) Dr LRgo, Head of Regulation of Medicines and Other Health Technologies (EMP/RHT) Dr SAzatyan, Regulatory Systems Strengthening (RSS/RHT) Dr RGBalocco Mattavelli, Manager, International Nonproprietary Names (INN) Programme,QSM Dr AFake, Prequalification of Medicines Programme, QSM Dr DMubangizi, Prequalification of Medicines Programme, QSM Dr JSabartova, Prequalification of Medicines Programme, QSM Dr KWeerasuriya, Policy Access and Rational Use (EMP/PAU) Traditional Medicine (Health Policy, Development and Services (HDS)/TRM)缺席。 Blood Products and Related Biologicals, QSM12 Medicines Regulatory Support Programme (MRS), QSM12 Mr D. Bramley (report writer) 利益声明 Members and temporary advisers of the WHO Expert Committee on Specifications for Pharmaceutical Preparations reported the following: Professor SBawazir, Dr LCargill, Dr ANasiri Kapour Chali, Professor TG Dekker, Dr XGe,Ms MHirschhorn, Professor JHoogmartens, Professor SJin, Dr BLi, Dr LPaleshnuik, Dr SParra, Dr JPrakash, Ms LSlamet and Dr JWelink reported no conflict of interest Professor JB Dressman reported that she was involved in a European Union (EU)research project partially related to biowaiver,under a grant issued to the University of Frankfurt, with no personal value She also reported that she was a member of the European Medicines Agency (EMA) Guidance Drafting Committee 2012-2013 and has been a member of the International Pharmaceutical Federation (FIP) Focus Group on “BCS/Biowaiver” since 2005, an unpaid position Professor HG Kristensen reported that he has provided testimonies as an independent expert on questions on validity and for infringement of patients at courts in Denmark, Norway and Sweden In all cases testimony is related to drug formulations No items conflicted with the subjects of the meeting Ms GN Mahlangu reported that she would receive an out-of-pocket allowance from her current employer, the Medicines Control Authority of Zimbabwe, in accordance with the travel allowances schedule for sponsored travel Dr AJ van Zyl reported that he has acted as a consultant for: the United States Pharmacopeia; the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the pharmaceutical industry; he further declared that he has prepared documentation and presented it for consideration by the Global Fund The declarations of interest were presented to the Expert Committee for information There were no comments from Committee members or advisers