Pharma & Biotech

China Reference Listed Drugs (RLD) application requirements for Chemical Generic Drugs was issued by the CDE in 2022.

China’s Center for Drug Evaluation has released its annual report for 2023.

China Contract Drug Manufacturing Provisions were issued back in October 2023 to strengthen the supervision and management of the entrusted production of drugs.

China is making it easier to transfer registrations of drugs initially manufactured abroad to Made-in-China status to improve availability and accessibility to medicines.

NMPA overseas factory inspection results have seen at least three medical device manufacturers notified by the authorities this week alone...

China’s CDE has issued guidelines to ensure accessibility for drug package inserts. It includes simplified and large-font format requirements.

China’s Center for Drug Evaluation has issued updates to the requirements for the electronic submission of drug registration applications.

China drug evaluation report 2022 was released by China’s Center for Drug Evaluation (CDE) in September 2023.

The NMPA has developed and built an API production and supply information collection module in the drug information collection platform.

Improve the management of the electronic filing for drug registration applications, the NMPA developed and promoted the eCTD.

Pre-Phase III drug clinical trial meeting guidelines have been released by the NMPA CDE for trial implementation as of March 22, 2023.

China’s Center for Drug Evaluation has released new Guidelines for Information on China Chemical Drug Instructions and Labels.