Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Laws & Regulations CDE Guidance Reference Listed Drug (RLD) Marketing Approval Bioequivalence (BE) OTC Drugs Gene Therapy Drug Registration New DrugsMonthly Recap: China Pharmaceutical Regulatory Updates | Dec 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
Laws & Regulations CDE Guidance Marketing Approval Clinical Trials Bioequivalence (BE) Post-market Drug Registration New DrugsMonthly Recap: China Pharmaceutical Regulatory Updates | Sept. 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
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
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2021 In Apr. 2021, China National Medical Products Administration (NMPA) and its subordinate body Center for Drug Evaluations (CDE) published a series of regulations on medical products, including pediatric medicine and biosimilars.
May 12, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
China Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
- China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
- China Adds 74 Drugs to National Reimbursement Drug List (NRDL)
- Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021
- China's Insulin VBP Saw Average Price Cut of 48.75%
- Monthly Report: New Drug Approvals in China | Nov. 2021