Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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
China Approves First Domestic CAR-T Therapy Fosun Kite's Axicabtagene Ciloleucel recently received marketing authorization by NMPA, becoming the first CAR-T therapy approved in China. The Chinese CAR-T industry is thus eyeing a promising future, but the road to market success is challenging.
Jul 12, 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