国家药品监督管理局于2021年9月启动了国际药品检查合作计划（Pharmaceutical Inspection Co-operation Scheme，PIC/S）的预加入申请工作，并于2023年11月8日成为正式申请者。PIC/S是国际性的GMP标准制定和推广机构，其GMP指南被广泛认为是药品生产质量管理的权威标准。此文对PIC/S与中国GMP的主文件结构与内容、无菌附录、生物制品附录的异同进行对比和研究，旨在查找和发现差距，为我国药品监管机构和药品生产企业提供改进措施，不断提升我国药品的质量和安全性，增强国际竞争力。

National Medical Products Administration started the pre-accession application for the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, and became a formal applicant on November 8, 2023. PIC/S is an international organization for developing and promoting GMP standards, and its GMP guidelines are widely regarded as authoritative standards for quality management in drug production. This paper compares and studies the similarities and differences between PIC/S and Chinese GMP in main document structure and content, aseptic appendix and biological product appendix, aiming at finding out the gap, providing improvement measures for drug regulatory agencies and drug manufacturers in China, continuously improving the quality and safety of drugs in China and increasing international competitiveness.