我国药品质量管理规范分析

Brief Analysis on the Standards of Drug Quality Management in China

随着药品种类及数量不断增长,药事活动不断开展,药品研发、生产、经营、使用中的问题层出不穷,我国食品药品监督管理总局出台了一系列药品质量管理规范,主要包括《药品生产质量管理规范》(GMP)《药品经营质量管理规范》(GSP)《药物非临床研究质量管理规范》(GLP)《药物临床试验质量管理规范》(GCP)《中药材生产质量管理规范》(GAP),并且在实际的药品监督管理工作中对药品的质量管理规范进行不断修订,逐渐完善。修订完善的药品质量管理规范将能够满足我国药品质量监督管理的需求。

With the increasing variety and quantity of medicines,the development of pharmaceutical activities and the emergence of problems in drug research and development,production,operation and use,China’s Food and Drug Administration has issued a series of drug quality management norms,including'Quality Management Standards for Pharmaceutical Production'(Good Manufacture Practice,GMP)and'Quality and Management Standards of Pharmaceutical Operation'(Good Supply Practice,GSP),Quality Management Standards for Non-clinical Drug Research(Good Laboratory Practice,GLP),Quality Management Standards for Clinical Drug Trials(Good Clinical Practice,GCP),Quality Management Standards for Production of Traditional Chinese Medicine(Good Agriculture Practice,GAP),and in the actual drug supervision and management work,the quality management norms for drugs are constantly revised and gradually improved.Revising and perfecting drug quality management standards will meet the needs of drug quality supervision and management in China.