Preparation and case analysis of DMF for chemical imitation API

The author introduces Jiang Qiao, Ph.D in physicochemistry, Nankai University, and postdoctoral in pharmaceutical chemistry, Zhejiang University Currently, he is the director of synthetic R & D in the API Business Department of Lizhu group Previously worked in Zhejiang Huahai Co., Ltd., Borui biomedical (Suzhou) Co., Ltd and Peking University Pharmaceutical Co., Ltd With 8 years of experience in chemical API product development and project management, familiar with API information research, patent analysis, route development, process optimization, pilot test certificate and production implementation, sewage treatment technology, registration document preparation So far, 22 pilot projects, 10 pilot projects and 10 production projects have been completed; 17 patents have been published (one submitted to PCT and entered the United States), 5 have been authorized; ctd3 has been prepared, and one submitted to DMF CTD document (common technical document) is an internationally recognized document preparation format, and CFDA became an official member of ICH on June 19, 2017 The application of CTD format is the bridge between China's drug declaration and the world, and the basic unity with the FDA / EMEA declaration system According to the federal administrative law of the United States, when entering the United States, the drug must apply for registration with the U.S FDA and submit relevant documents, and the chemical API must submit a drug management file (DMF) as required In the 48th session of the College of pharmacy and intelligence, Dr Jiang explained in detail how to write the chemical imitation API DMF, combining with specific examples The following is the original PPT and shared with you ~ ~ in addition, if you want to get 121 pages of "DMF file samples", you can add Yao Xiaozhi (17318481750) as your friend, and let Xiaozhi send it to you separately~~