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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Drug Recall in China: MAHs Shall Shoulder the Main Responsibility
China NMPA's new Administrative Measures for Drug Recall will take effect on Nov. 1, 2022. Different from the previous 2007 version, the new Measures designates drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.
Oct 31, 2022
INDUSTRY
MAH
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Diabetes
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | August 2022
In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022
REGULATION
Key Points for Manufacturing Entrustment Under China's Marketing Authorization Holder (MAH) System
China's drug marketing authorization holder (MAH) system was first piloted in China in 2015 and officially implemented in 2019. It allows MAHs to entrust manufacturing activities to other companies.
Jul 29, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022
Check out the pharmaceutical regulatory updates in China: 1.CDE Issues the 2021 China Drug Evaluation Report; 2. CDE Publishes the 2021 Clinical Trial Report; 3. CDE Consults on Communication Procedures for Pediatric Drug Applicants...
Jul 06, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Marketing Approval
CMC
Clinical Trial
Generic Drug
Cell Therapy
Gene Therapy
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 2022
REGULATION
Law & Regulation
MAH
Pharmacovigilance
Marketing Approval
Priority Review
Health Insurance
Innovative Drug
Generic Drug
Rare Disease
Drug Registration
New Drug
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
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