Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Laws & Regulations Reference Listed Drug (RLD) Marketing Approval Priority Review and Approval Innovative Drugs Generic Drugs Drug Registration New DrugsHow Will China Regulate and Boost Pharmaceutical Industry by 2025 At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
Laws & Regulations CDE Guidance Reference Listed Drug (RLD) Marketing Approval Bioequivalence (BE) OTC Drugs Gene Therapy Drug Registration New DrugsMonthly Recap: China Pharmaceutical Regulatory Updates | Dec 2021 1. China Approves Its First COVID-19 Therapy; 2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels; 3. China NMPA Adjusts Over-the-Counter (OTC) Catalog; 4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs); 5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards; 6. Pharmaceutical Guidelines
Jan 13, 2022
Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021 1. China Insulin VBP Tender Result; 2. NMPA Launches Drug Supply Information Submission System; 3. NMPAs Requires Documentation for Import/Export Permit of Analgesics and Antipsychotics; 4. NMPA Announces One Rx-to-OTC Switch; 5. The 48th Batch of Reference Listed Drugs; 6. NMPA Approves 110 Medical Devices; 7. NHC Releases Administrative Measures for National Essential Medicine List (Revised Draft); 8. NMPA Releases Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)...
Dec 16, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021 1. NMPA Releases the 44th Batch of Reference Listed Drugs; 2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing; 3. NMPA Announces Four Rx-to-OTC Switches...
Sep 30, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
- China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
- China Adds 74 Drugs to National Reimbursement Drug List (NRDL)
- Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021
- China's Insulin VBP Saw Average Price Cut of 48.75%
- Monthly Report: New Drug Approvals in China | Nov. 2021