Pharmaceuticals & DMF Archive

Monday, 2, March, 2026 / Published in China, News, Pharmaceuticals & DMF

China CDE Issues New 2026 Trial Guidelines for Insomnia, Neuropathic Pain, and Depression Drugs

On February 4 and February 6, 2026, China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA)…

Thursday, 26, February, 2026 / Published in China, News, Pharmaceuticals & DMF

NMPA CDE Releases Trial CMC Guideline for Preventive mRNA Vaccines — What Developers Must Prepare

On January 28, 2026, China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) issued “CDE Notice No. 12…

Close-up of gloved hands drawing blue liquid into a syringe from a small vial, with translucent molecular structures and shield icons overlaid to symbolize laboratory testing, product safety, and regulatory compliance in the pharmaceutical and biotechnology sectors. The clinical setting and protective gloves highlight quality control, product registration, and market access processes for healthcare products in China and Asia-Pacific markets.

Thursday, 26, February, 2026 / Published in China, News, Pharmaceuticals & DMF

China CDE Issues Trial Guidance on CMC Changes for Cell Therapy Drugs

On January 30, 2026, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued Technical Guiding Principles for Research and…

Wednesday, 25, February, 2026 / Published in China, News, Pharmaceuticals & DMF

China NMPA Applies ICH M14 to Non-Interventional Safety Studies using Real-World Evidence

On January 26, 2026, the National Medical Products Administration (NMPA) issued “Announcement No. 16 of 2026,” published on January 27, 2026, confirming…

Tuesday, 24, February, 2026 / Published in China, News, Pharmaceuticals & DMF

China’s 2026 Drug Regulation Revision: How State Council Decree No.828 Elevates Innovation and Tightens Lifecycle Accountability

China is entering a new phase of pharmaceutical regulation. One defined by faster access to clinically meaningful innovation paired with…

Tuesday, 24, February, 2026 / Published in China, News, Pharmaceuticals & DMF

China CDE Launches Consultations on 3 Draft Guidelines: Oligonucleotide Drugs, Advanced Therapies, and Post-Approval Changes to Biologics

On 8 and 11 September 2025, China’s Center for Drug Evaluation (CDE) launched three public consultations on draft guidelines that…

Pharmaceuticals & DMFCategory:

China CDE Issues New 2026 Trial Guidelines for Insomnia, Neuropathic Pain, and Depression Drugs

NMPA CDE Releases Trial CMC Guideline for Preventive mRNA Vaccines — What Developers Must Prepare

China CDE Issues Trial Guidance on CMC Changes for Cell Therapy Drugs

China NMPA Applies ICH M14 to Non-Interventional Safety Studies using Real-World Evidence

China’s 2026 Drug Regulation Revision: How State Council Decree No.828 Elevates Innovation and Tightens Lifecycle Accountability

China NMPA Expands Fast-Track Access for Overseas Drugs

China NHC Issues Fourth Batch of Encouraged Generic Drugs Catalogue

China NMPA Releases GCP for Drugs (2025) Draft Revision: Key Changes and 2020 GCP Comparison

CDE Releases Draft Measures to Enhance Drug R&D and Review Communication

China CDE Launches Consultations on 3 Draft Guidelines: Oligonucleotide Drugs, Advanced Therapies, and Post-Approval Changes to Biologics