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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation CDE 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 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 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 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 Reference Listed Drug (RLD) Marketing Approval DMF Biological Product API Drug Registration New Drug
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 CDE Guideline Reference Listed Drug (RLD) Marketing Approval Clinical Trial Volume-Based Procurement Generic Drug Biosimilar New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2022 1. China Pilots Online Sales of Prescription Drugs in Shenzhen; 2. National Insulin Procurement to Start in May; 3. China NMPA Grants Two Rx-to-OTC Switches; 4. China NMPA Releases the 50th Batch of Reference Listed Drugs; 5. China NMPA Approves 221 Medical Devices; 6. China NMPA Issues Three Industry Standards for Medical Devices; 7. Pharmaceutical Guidelines.
Feb 10, 2022
REGULATION
Law & Regulation CDE Guideline Reference Listed Drug (RLD) Marketing Approval Bioequivalence (BE) OTC Drug Gene Therapy Drug Registration New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2021 1. China Approves Its First COVID-19 Therapy; 2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels; 3. China NMPA Adjusts Over-the-Counter (OTC) Catalog; 4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs); 5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards; 6. Pharmaceutical Guidelines
Jan 13, 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
REGULATION
Law & Regulation CDE Guideline
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021 1. NMPA releases the 43rd batch of reference listed drugs; 2. NMPA announces nine Rx-to-OTC switches; 3. NMPA and CNIPA rolls out measures for resolving drug patent disputes...
Aug 24, 2021
REGULATION
Law & Regulation CDE Guideline Biological Product
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2021 The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
Jul 20, 2021
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