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Online Conference | China Drug Regulation and Pharmaceutical Market
BaiPharm will hold a virtual conference on Nov. 12, as part of the CRAC-HCF 2021 event. We will have five speeches elaborating on China drug regulations and pharmaceutical market. The specific topics include China market entry strategy, Chinese Pharmacopoeia, GVP, MAH, and innovative drug research.
Oct 21, 2021
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
INDUSTRY
China Approves First Domestic CAR-T Therapy
Fosun Kite's Axicabtagene Ciloleucel recently received marketing authorization by NMPA, becoming the first CAR-T therapy approved in China. The Chinese CAR-T industry is thus eyeing a promising future, but the road to market success is challenging.
Jul 12, 2021