申报副研究员述职报告.ppt

Biopharmaceutical Industrialization and Quality Requirements Research in China Wang Jun Zhi (王军志） Ph. D Deputy Director National Institute for the Control of Pharmaceutical Biological Products I. Brief Introduction of History of Biological Productsin China Before 1949: The research, production, and application of biological products in China were since 1919. Biological products developed slowly and in small scale, only several kinds of biological products before 1949. II. The managements of Biological products in China 1. Regulation “The Drug Administration Law of the People’s Republic of China” Technical Regulation: 《Chinese Pharmacopoeia》2000、 《Requirements for Biologics of People’s Republic of China》2000 other technical guidelines issued by SFDA 2、Organization SFDA、 NICPBP、 CDE、 The committee of Chinese pharmacopia, Experts of committee The center of the validation (GMP, GCP, GLP) ADR 3. Main Responsibilities Registration and approval Technical supervision、 Quality Control 生物制品国家管理的6项基本职能（Functions of national management of Biologices WHO） 1.一整套有关疫苗和生物制品审批程序和审批标准的法规文件 (Procedure and standard of documents for approval) 2.审批结论应以临床试验数据为依据(Conclusion of review should be basic on data of GCP) 3.对疫苗和生物制品的出厂销售实行国家批签发制度(Lot release system for vaccine and biological) 4.应有对制品进行质量评价的实验室设施(The quality control Lab. is necessary.) 5.对企业实施GMP的状况进行定期检查(The examination of GMP in a period time) 6.对其有效性和不良反应进行上市后监测(Implementation of ADR) Legal basis of lot release “The Drug Administration Law of the People’s Republic of China” The implementation of Lot Release in China Since December 31, 2001, lot release for the 5 EPI vaccines (DTP, BCG, OPV, rDNA HepB Measles) and Human Serum Albumin have being implemented. WHO Collaborating Center for Drug Quality Assurance To collaborate in the development of basis tests (simplified methodology) for testing essential drugs in the WHO program. To coordinate the est