
2025年全球医药监管指南:中国与国际最新法规动态解读
BLUF2025年1月,国内外药械监管机构发布多项重要更新,包括中国CFDI的《药品无菌保证工艺指南》及NMPA对GMP附录的修订,旨在强化无菌药品和原料药的生产质量监管,助力行业合规与市场准入。
原文翻译:
In January 2025, domestic and international pharmaceutical and medical device regulatory agencies issued several key updates, including China's CFDI "Guidelines for Sterility Assurance in Drug Manufacturing" and NMPA's revisions to GMP appendices. These aim to strengthen quality supervision in the production of sterile drugs and APIs, facilitating industry compliance and market access.
AI大模型2026/1/24
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