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
Best-selling Ophthalmic Drugs in China | Market Wrap 2021 The year 2021 has seen a remarkable growth of the ophthalmic drug market in China. The market size of chemical drugs for eye diseases is estimated to exceed 3.5 billion yuan (circa 549 million USD), with a year-on-year growth of 1.89%.
Jan 10, 2022
Laws & Regulations Pharmacopeia MAH Pharmacovigilance Marketing Approval Priority Review and Approval Volume-Based ProcurementTop 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications China will carry out pre-approval inspections on R&D and manufacturing sites involved in drug registration applications. When necessary, the inspections can extend to relevant API, excipient, packaging material manufacturers, suppliers, and contract organizations.
Dec 24, 2021
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
China Adds 74 Drugs to National Reimbursement Drug List (NRDL) On Dec. 3, China released its 2021 National Reimbursement Drug List (NRDL). NRDL is a list of drugs allowable for reimbursement by the national social health insurance fund under the social security system which has covered more than 1.36 billion people in China by the end of 2020.
Dec 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