《化学仿制药晶型研究技术指导原则(试行)》解读

Interpretation of″Guidance on Polymorphism Study of Chemical Generic Drugs(Trial)″

近年来,药物的晶型研究已成为国际药学领域的研究热点,为鼓励和促进国内制药企业的化学仿制药发展,明确化学仿制药研发过程中晶型研究的关注点,国家药品监督管理局药品审评中心于2022年1月4日正式发布了《化学仿制药晶型研究技术指导原则(试行)》。本文结合该指导原则的起草背景,充分考虑仿制药开发的特点,对指导原则内容和重点问题进行详细解读,以供业界更好的理解和运用。

In recent years,polymorphism study of chemical drugs has become a research hotspot in the international pharmaceutical field,in order to encourage and promote the development of chemical generic drugs in domestic pharmaceutical enterprises,and clarify the focus of crystal research in the process of chemical generic drug research and development,the Center for Drug Evaluation of National Medical Products Administration officially issued the"Guideline on Polymorphism Study of Chemical Generic Drugs(Trial)"on January 4,2022.A detailed interpretation of the guidance is provided in this paper,combined with the drafting process of the guidance and fully considering the characteristics of generic drug development,in order to help applicants to get a better understanding and application.