Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China to Accept eCTD Format for Marketing Authorization Applications for Specific Classes of Drugs China will start to accept the eCTD format for drug applications on Dec. 29, 2021 while still allowing drug applicants to stay with the current method—submitting compact disks containing dossiers.
Oct 14, 2021
New IVD Reagent Registration and Filing Rules Take Effect in China 1. The Measures’ Application Scope; 2. Definition of IVD Reagents in China; 3. IVD Reagent Classification in China; 4. Definition and Application Scope of IVD Reagent Registration/Filing in China; 5. Qualification of Registration/Filing Applicant and Local Agent; 6. Competent Authority to Submit Application/Documentation to; 7. Documentation for IVD Reagent Registration Application/Filing; 8. Special Approval for IVD Reagents; 9. Product Change and Certificate Validity Extension; 10. Adjusting the Class of Registered IVD Reagents.
Oct 08, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021 1. NMPA Releases the 44th Batch of Reference Listed Drugs; 2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing; 3. NMPA Announces Four Rx-to-OTC Switches...
Sep 30, 2021
China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation. Both are scheduled to take effect on Oct. 1, 2021.
Sep 24, 2021
China Rolls Out Measures to Establish Drug Patent Linkage System China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.
Jul 23, 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
China Takes New Measures for GMP & GSP Inspection China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Jun 15, 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | Aug. 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021
- China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials