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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
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