Notice from the Drug Review Center of the National Medical Products Administration on the Release of the

In order to implement the "Opinions of the General Office of the State Council on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High quality Development of the Pharmaceutical Industry" (Guobanfa [2024] No. 53), improve the quality of generic drug application materials, and promote the improvement of generic drug quality, the Drug Evaluation Center has organized the drafting of the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Raw Material) (Trial)" and the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Preparation) (Trial)" (hereinafter referred to as the writing requirements, see attachments 1 and 2) based on the practice of drug evaluation.