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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
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
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
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
REGULATION
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
REGULATION
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
REGULATION
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
REGULATION
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
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