Baipharm
ChemLinkedMarketChemicalFoodCosmeticBaiPharm Agrochemical Japan
News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 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 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
REGULATION
Law & Regulation CDE Guideline Marketing Approval Clinical Trial Bioequivalence (BE) Post-market Drug Registration New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2021 1. China's eCTD Format for Drug Marketing Application Dossiers; 2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing. 2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials; 2.3. NMPA Releases Format Requirements for Medical Devices’ or IVD Reagents’ Registration Application Dossiers and Approval Documents; 2.4. Guidelines on Medical Devices and IVD Reagents; 2.5. NMPA Releases Medical Device Industry Standards; 2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers; 3. NMPA granted Aloe Vera Pearl Capsules OTC Status; 4.A Collection of Sept. Guidelines Released by NMPA or CDE
Oct 31, 2021
INDUSTRY
Law & Regulation Post-market
Adverse Drug Reaction in China: Important Numbers from 2020 Report In 2020, China's National Monitoring System of Adverse Drug Reaction (ADR) received a total number of 1.676 million reports of ADR events.
Mar 31, 2021
REGULATION
Law & Regulation MAH Pharmacovigilance Post-market
China Requires Drug Market Authorization Holders to Submit Annual Report On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Mar 08, 2021
REGULATION
MAH Pharmacovigilance Post-market
China Consults on the Draft of Good Pharmacovigilance Practices On Dec. 1, 2020, the National Medical Products Administration (NMPA) issued the draft of Good Pharmacovigilance Practices (GVP) for public comments. Stakeholders could submit feedback to NMPA before Dec. 18, 2020.
Mar 08, 2021
Most Popular