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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
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Pharmacovigilance
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China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
Marketing Approval
CMC
Bioequivalence (BE)
Post-market
Generic Drug
Biosimilar
Cancer
New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022
Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
GMP
Marketing Approval
Post-market
Generic Drug
Vaccine
GCP
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2022
Check out the pharmaceutical regulatory updates in China: NMPA releases the 52th list of reference listed drugs; China NMPA consults on drug MAH's inspection regulation...
Apr 08, 2022
REGULATION
Monthly 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
REGULATION
Law & Regulation
Marketing Approval
Clinical Trial
Priority Review
Innovative Drug
API
Rare Disease
New Drug
The 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
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