Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Law & Regulation CDE Guideline Reference Listed Drug (RLD) Marketing Approval DMF Biological Product API Drug Registration New DrugMonthly Recap: China Pharmaceutical Regulatory Updates | February 2022 1. CDE Releases its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial); 2. CDE Consults on the Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs; 3. CDE Releases the Consultation Draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial); 4. NMPA Releases the 51st List of Reference Listed Drugs; 5. NMPA Publishes the 2022 Plan for Random Inspection of Medical Devices; 6. NMPA Reveals the List of 208 Medical Devices Approved in January 2022; 7. Guidelines for Pharmaceutical Industry.
Mar 10, 2022
Law & Regulation Marketing Approval Clinical Trial Priority Review and Approval NRDL Volume-Based Procurement Medical Insurance Innovative Drug API Rare Disease New DrugThe 15th Rare Disease Day: China's Policy & Market Overview China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022
China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry On Nov. 18, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients, clarifying regulations against monopoly agreements, abuse of market power, and concentration of undertakings in the API industry.
Nov 26, 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 Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
China to Exempt Import Tariffs on 61 Active Pharmaceutical Ingredients for Anticancer and Rare Disease Drugs China will apply interim import tax rates that are lower than most-favored-nation tariffs on 883 kinds of goods from Jan. 1, 2021, according to the 2021 Tariff Adjustment Plan issued by the Customs Tariff Commission of the State Council on Dec. 23, 2020.
Mar 08, 2021
- How to Sell OTC Drugs to China Through Cross-Border E-Commerce
- China NMPA Announces Key Points for Pharmacovigilance Inspections
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- China Implements New Rules on Drug MAH's Annual Reports
- Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case