浅谈建立药学研究质量管理规范的必要性与可行性

Necessity and feasibility of establishment of good practice for chemistry, manufacturing and control

本文结合现有法规要求及我国药物研发机构研发状况,分析药学研究质量管理规范建立的必要性,提出药学研究质量管理规范建立的可行性。为提升我国药物研发水平,迫切需要建立行之有效的药学研究质量管理规范。

We analyzed the necessity of establishment and enforcement of good practice for chemistry, manufacturing and control （CMC） study under current regulatory requirements and status of drug R＆D institutions. We put forward the feasibility of establishing of good practice for CMC. It is urgent to establish good practice for CMC study to promote drug R＆D in China.