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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Law & Regulation
CDE Guideline
Reference Listed Drug (RLD)
MAH
Pharmacovigilance
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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
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
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
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