Pharma & Biotech

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 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.

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....

The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…|The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…

The Center for Drug Evaluation (CDE) issued Traditional Chinese Medicine clinical development guidelines on November 19, 2024....

The NHSA has released the 2024 National Medical Insurance Drug List (NEDL) and launched updates regarding this year’s drug price....

The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...|The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...

Document No. 53, outlining comprehensive reforms aimed at strengthening the regulation of pharmaceuticals and medical devices. These reforms..

Learn the registration requirements, scope, and compliance steps as Hong Kong regulates medical gases as pharmaceutical products.

The revised law establishes strict standards and measures in supervision over the whole process of the pharmaceutical industry chain

China's GCP for Drugs (2025) Draft Revision proposes major updates on data governance, sponsor accountability, ethics, and technology use.

China’s CDE released three 2026 trial guidelines on Phase III design for chronic insomnia, neuropathic pain, and depressive disorders.