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…
On July 2, 2020, the National Medical Products Administration (NMPA) and the National Health Commission of the People’s Republic of China (NHC) announced the Chinese Pharmacopoeia 2020 Edition. Read NMPA announces the implementation of the Chinese Pharmacopoeia 2020 edition This is the 11th edition of Chinese Pharmacopoeia and will be officially implemented from December 30,…
