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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 86th RLD Lists, 2.China Releases the Fifth List of Pediatric Drugs Encouraged for R&D, 3. China CDE Completes the Consultation on Q&A on Pharmaceutical Similarity Studies of Biosimilars; 4. China CDE Launches Patient-Centered Action for Rare Diseases Encouragement, 5. China NHSA Releases Expert Evaluation Results for Drugs Applied for Inclusion of 2024 NRDL
Oct 12, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 85th RLD Lists, 2. China NHSA Announces 440 Drugs Having Passed the Format Review for NRDL, 3. China NMPA Grants Five Rx-to-OTC Switches, 4. China Consults on the Overarching Regulation of Medical Devices, 5. China CDE Releases the 82nd RLD List...
Sep 12, 2024
REGULATION
China Releases The Fifth List of Pediatric Drugs Encouraged for R&D
On September 9, China's National Health Commission (NHC), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) jointly announced the Fifth List of Pediatric Drugs Encouraged for R&D and Marketing Authorization, containing 15 drugs in total.
Sep 11, 2024
REGULATION
China Consults on the Overarching Regulation of Medical Devices
On August 28, 2024, China’s National Medical Products Administration (NMPA) released the Draft for Comments on the Medical Device Administration Law for public consultation. The draft places particular emphasis on fostering innovation and enhancing regulatory oversight throughout the entire lifecycle of medical devices.
Aug 30, 2024