Pharma & Biotech

The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....|The CDE of China published a draft of the Guidelines for Benefit-Risk Assessment Based on Multi-Regional Clinical Trial Data in Global....

One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...

...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).|...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).

China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.|China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.

China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders|China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders

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