《化学仿制药晶型研究技术指导原则(试行)》解读OACSTPCD

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.