新法规下仿制药研发中几个关键问题的思考

Considerations on Several Key Issues during the Research and Development of Generic Drugs under the New Regulations

目的提出对仿制药研发思路和策略相关问题的认识和建议,以期在药物研发中得到相应关注和改进,提高我国药物研发的水平和质量。方法根据新版《药品注册管理办法》对仿制药注册申请提出的技术要求,从药物研发规律、药品质量及其形成过程和控制要素出发,在仿制药研发的立题思考、研发理念、生产工艺与质量相关性等方面,阐述仿制药的研发思路和质量控制要素。结果与结论"质量源于设计、过程决定质量、检验揭示品质"将是药品研发过程中科学的世界观和方法论,"桥接的研究思路、对比的研究策略"是仿制药研发的基本思想,要充分体现在药物研发的科学实践中。

Objective To propose knowledge and recommendations for issues related to RD ideas and strategies for generic drugs to obtain corresponding concerns and improvements during drug RD,thus to improve the level and quality of drug RD in our country. Methods According to the technical requirements on generic drug applications prescribed in the new edition of ＂Provisions for Drug Registration＂,describe RD ideas and quality control elements of generic drugs with respect to considerations on rationale for study,RD concepts,manufacturing process and quality relevance of generic drug RD from the perspective of drug RD rule,drug quality and its formation process and control elements. Results and conclusion ＂Quality by design,quality depending on process,and quality revealed by inspection＂ will be the scientific world outlook and methodology during drug RD. ＂bridging study idea and comparative study strategy＂ is the basic idea for generic drug research and development,which shall be fully reflected in the scientific practice of drug research and development.