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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 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
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
REGULATION
China CDE to Disclose New Drugs' Technical Review Reports
China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Mar 08, 2021
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