Pharma & Biotech

China rare disease drugs clinical pharmacology research technical guidelines have been drafted for comments by the CDE on October 12, 2024.

GBA Connect Scheme has approved 79 medical products—39 pharmaceuticals and 40 devices—benefiting ~10,000 GBA patients as of October 9, 2024.

Hong Kong 2024 Policy Address: Key regulatory updates on medical product approvals and initiatives to enhance biomedical research.

China pediatric drugs encouraged for R&D – fifth batch have been announced by the NHC and other 3 organizations on August 30, 2024.

A trial program for the online submission of China drug registration application documents started on July 1, 2024.

China’s CDE has issued a draft document titled “Q&A on Clinical Trial Requirements for Drugs Listed Outside China and Not Listed in China.”

New Greater Bay Area regulations for importing Hong Kong drugs and medical devices starting December 1, 2024 will reduce review time

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.