Pharma & Biotech

China’s NMPA has explored numerous AI use cases in Pharma. The scenarios aim to promote AI research and AI applications in drug regulation.

The China CDE has issued its 2023 Annual Report reviewing the trend in Clinical Trials Applications for New Drug Registrations).

Drug registration in China for transferring Biological Therapeutics products marketed abroad to in China has a clear set of guidelines.

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

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

To improve the review process, a 60-day response period allows applicants to address any deficiencies identified by the Hong Kong Drug Office

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.

Regulatory Science for Pharmaceutical Innovation and Internationalization Conference took place on April 28, 2024, sharing GBA market insights

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

China Greater Bay Area demand for medical products surges as Guangzhou customs supervised over 101 batches of imported products in 2023...

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

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