Tag Archives: China NDA approval

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…