China DMF Inactive Number by CDE. Complete but not approved. China DMF Active Number by CDE. Activated/Approved. For Drug master filing (DMF) in China, there is a new guideline released by China’s NMPA (Formerly CFDA) in 2019 for the scope of active pharmaceutical ingredients (APIs), excipients and packaging materials. Similar to the systems of…
Part 2. Chemical Drugs, Biological Products and Traditional Chinese Medicines Table of contents 1. Chemical Drugs. 1.1. Application Overview. 1.2. Approval. 2. Biological Products. 2.1. Application Overview. 1.2. Approval. 3. Traditional Chinese Medicine. 3.1. Application Overview. 3.2. Approval. Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of China reviewed…
Table of contents 1. Summary. 2. Technical Review & Approval. 3. Reason For Application Rejections. 3.1 New Drug Application Rejections. 3.2 ANDA Rejections. 3.3 Supplementary Application Rejections. 3.4 Other Application Rejection. In 2020, the Center for Drug Evaluation (CDE) of China reviewed and/or approved 11,582 drug registrations. To summarize the accomplishments and failures of…
In the first quarter of 2020, the National Medical Products Administration (NMPA) approved a total of 11 new drugs including 6 imported drugs and 5 domestic drugs. Among them, domestic medicines also have a vaccine and a traditional Chinese medicine as the table below shows. Note: Here the NDAs are the drugs approved by NMPA…
