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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023
Check out the latest pharma regulatory updates in China: 1. China NMPA Applies for PIC/S Membership; 2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs; 3. China NMPA Grants Three Rx-to-OTC Switches; 4. China Includes 195 Drug Products in Its 9th National VBP; 5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions; 6. China NMPA Consults on Anesthetics and Psychotropics Regulations; 7. China CDE Releases Pharmaceutical Guidelines; 8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Nov 30, 2023
INDUSTRY
Marketing Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Rare Disease
Drug Registration
New Drug
Respiratory Disease
Monthly Report: New Drug Approvals in China | October 2023
In Oct 2023, China NMPA approved 15 new drugs, among which 12 are chemical drugs and 3 are biological products: 1. BMS’ Deucravacitinib Tablets (SOTYKTU); 2. Pfizer’s Ritlecitinib Tosylate Capsules (LITFULO); 3. Janssen-Cilag International’s Rilpivirine Injection; 4. Luye Pharma’s Rivastigmine Twice Weekly Transdermal Patch; 5. Abbvie’s Upadacitinib Sustained-release Tablets (RINVOQ)...
Nov 06, 2023
REGULATION
INDUSTRY
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Rare Disease
Drug Registration
Monthly Report: New Drug Approvals in China | September 2023
In Sept. 2023, China NMPA approved 19 new drugs, among which 12 are chemical drugs and 7 are biological products:
1. Luye Life Sciences’ Goserelin Microspheres for Injection
2. HRA Pharma Rare Diseases’ Mitotane Tablets
3. N.V. Organon’s Ezetimibe and Atorvastatin Calcium Tablets
4. Napp Pharmaceuticals’ Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation
5. Sinotau Pharmaceuticals’ Florbetaben [¹⁸F] Injection (Ouweining)
6. Grand Pharma’s Carglumic Acid Dispersible Tablets (Anweide)
7. CSPC Ouyi Pharmaceutical’s Irinotecan Hydrochloride Liposome Injection
8. Qilu Pharmaceutical’s Dolutegravir Sodium Tablets
9. Gowell Pharma’s ω-3 Fish Oil Fat Emulsion Injection
10. Acebright Pharma’s Neratinib Maleate Tablets
11. Brilliant Pharmaceuticals’ Dacomitinib Tablets
12. Grand Life Sciences’ Etomidate Injectable Emulsion
13. Shanghai JMT-Bio Technology’s Narlumosbart Injection
14. Henlius’ Serplulimab Injection (Hansizhuang)
15. Eli Lilly’s Insulin Lispro Injection (Youmile)
16. Sanofi’s Dupilumab Injection (Dupixent)
17. Eli Lilly’s Dulaglutide Injection (TRULICITY)
18. MSD’s Pembrolizumab Injection (Keytruda)
19. Novartis’ Erenumab Injection (Aimovig)
Oct 09, 2023
POLICY
Zhou Siyuan Nominated as China Center for Drug Evaluation's New Director
China’s Center for Drug Evaluation (CDE) recently revealed a change in its leadership—Zhou Siyuan replaces Kong Fanpu as the new director. As an office under the National Medical Products Administration (NMPA), CDE is mostly known for its function of conducting technical review/evaluation of drug registration applications.
Aug 30, 2023
POLICY
China Encourages Pediatric Drugs' Development and Marketing Authorization
On Aug. 23, 2023, China released the 4th List of Pediatric Drugs Encouraged for Development and Marketing Authorization. The list contains 24 drugs, involving 30 strengths, 9 dosage forms, and multiple therapeutic areas such as nervous system diseases, gastrointestinal system, metabolic disorders, tumors, and immune disease.
Aug 24, 2023
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