Pharma & Biotech

China’s NMPA has suspended the import, sale and use of Cefodizime Sodium for injection by DAEWOONG BIO Inc following its rejection of an NMPA inspection request at its production site.

China’s NMPA has issued a pilot program to optimize innovative new drug clinical trial review and approvals. in Beijing and Shanghai have been approved as the first pilot regions.

China’s NMPA has issued a draft for comments on an updated Good Manufacturing Practice – GMP for Excipients and Packaging. The deadline to submit feedback is 20 August 2024.

Post-market changes to Active Pharmaceutical Ingredients in China now have clearer guidance thanks to a recently published Q&A from CDE.

The NMPA is requesting comments on China drug approvals of Clinically Urgent Overseas Drugs. The deadline to submit comments is July 24, 2024.

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.