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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation
China to Renew Medical Sodium Hyaluronate's Administrative Classifications China is going to renew the administrative classifications of medical sodium hyaluronate products according to their intended uses and mechanisms of action.
May 27, 2022
REGULATION
Law & Regulation CDE Guideline Clinical Trial Post-market Cancer GCP
China Implements Guidelines on Immune-related Adverse Event (irADR) in Immuno-oncology In the Guidelines, China CDE proposes the definition of irAE as all levels of adverse drug reactions (ADR) that are confirmed to have causal connections with the immune mechanism.
May 20, 2022
REGULATION
Law & Regulation Pharmacovigilance Post-market
China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports MedDRA is a standardized medical terminology developed by the ICH. China's Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports.
May 18, 2022
REGULATION
Law & Regulation Pharmacopoeia
China Issues Corrigenda for the Chinese Pharmacopoeia (ChP) 2020 Chinese Pharmacopoeia Commission corrects the chemical structure depiction of the impurity C18H21N3O2S in Raberazole Sodium.
May 16, 2022
REGULATION
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical 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 CDE 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 Marketing Approval Innovative Drug Generic Drug Drug Registration New Drug
Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case China's IP court rules that Wenzhou Haihe Pharma’s generic drug is outside Chugai Pharma's Patent Claim 1 for the brand-name version of Eldecalcitol Soft Capsules.
Apr 24, 2022
REGULATION
Law & Regulation Pharmacovigilance Post-market
China NMPA Announces Key Points for Pharmacovigilance Inspections Marketing authorization holders that entrust the manufacturing of drugs to a third party will receive special attention from drug regulators in pharmacovigilance inspections.
Apr 21, 2022
REGULATION
Law & Regulation Post-market
China Implements New Rules on Drug MAH's Annual Reports China NMPA requires Marketing authorization holders (MAH) to submit annual drug reports to the online system Drug Annual Report Collection Module.
Apr 21, 2022
REGULATION
Law & Regulation CDE 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
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