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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 | 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
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Accepts Online Submission of Electronic Drug Registration Documents; 2. China Customs Consults on the Importation of Bezoar; 3. China NMPA Grants Three Rx-to-OTC Switches; 4. China NMPA Consults on Good Manufacturing Practices for Excipients and Packaging Materials; 5. China NMPA Launches Pilot Program to Speed Up Approval for Innovative Drug Clinical Trials
Aug 07, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 83rd and 84th RLD Lists; 2. China CDR Invites Public Feedback on the Draft Procedure for Converting Prescription Drugs to OTC Drugs; 3. China NMPA Releases Three Documents on Blood Products; 4. China CDE Releases Dossier Requirements for Imported Therapeutic Biological Products’ Transfer to Domestic Production
Jul 14, 2024
REGULATION
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Rare Disease
China Consults on New Policy to Expedite Approval of Clinically Urgent Overseas Drugs
In a move aimed at accelerating the approval process for clinically urgent overseas drugs, China's National Medical Products Administration (NMPA) has drafted a new announcement titled "Notice on Further Optimizing the Review and Approval of Clinically Urgent Overseas Drugs (Draft for Public Comment)."
Jun 28, 2024
