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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
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
REGULATION
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
REGULATION
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
INDUSTRY
Marketing Approval
Priority Review and Approval
Innovative Drugs
Generic Drugs
Drug Registration
New Drugs
Monthly Report: New Drug Approvals in China | Aug. 2021
In Aug. 2021, China NMPA nodded for nine new drug products including Tislelizumab Injection, Apremilast Tablet and Nivolumab Injection.
Sep 14, 2021
REGULATION
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
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
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