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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Tightens Regulation on Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs)
On Oct. 23, 2023, China's NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs), which took immediate effect.
Oct 26, 2023
POLICY
China's 9th Volume-based Procurement (VBP) of Drugs to Impact Market Valued Over USD 2.32 Billion
Out of the 42 drugs to be enrolled in China’s 9th VBP, the top 10 best-selling drugs accounted for approximately USD 2.32 billion in sales in 2022. Two drugs—the immediate-release dosage forms of rabeprazole and propofol injections—each exceeded 3.5 USD billion in last year’s sales.
Oct 20, 2023
REGULATION
China Requires ANDAs Without Reference Drugs to Demonstrate Clinical Value
For generic candidates without reference listed drugs, China's NMPA requires the applicant to conducting CM) studies to prove the proposed generic drug’s equivalence to the marketed drug with the same API, assesses and demonstrates the proposed drug’s clinical value, and submits a communication application for having a type-III meeting with CDE.
Oct 17, 2023
REGULATION
REGULATION
Chinese Pharmacopoeia 2020 Edition's 1st Addendum: 54 Additions and 607 Revisions
On Oct.13, 2023, China’s NMPA and NHC jointly announced the release of the first Addendum to the Chinese Pharmacopoeia 2020 Edition. It was stated that the Addendum has been compiled and is planned to be implemented on March 12, 2024.
Oct 13, 2023
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
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Innovative Drug
Generic Drug
Rare Disease
Cell Therapy
Gene Therapy
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023
China pharma regulatory updates in Sept. 2023: 1. NMPA Publishes the 2022 China Drug Evaluation Report; 2. NHC Releases the 2nd Catalog of Rare Diseases; 3. NMPA Adjusts Anesthetic and Psychotropic Drug Catalogs; 4. CDE Unveils 2022 Report on the Progress of New Drug Clinical Trials in China; 5. NMPA Grants Three Rx-to-OTC Switches; 6. ICH, NMPA, and CDE Release Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
Oct 08, 2023
REGULATION
China to Dismiss Overdue Equivalence Evaluation Applications for Generics
On Sept. 25, 2023, China CDE released the draft of the Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs, stating that the CDE will no longer accept equivalence evaluation applications for generic drugs of the same type if they are submitted three years or more after the first generic drug passes the equivalence evaluation.
Sep 28, 2023
POLICY
China Releases the 2nd Catalog of Rare Diseases
On Sept. 20, 2023, China released the 2nd Catalog of Rare Diseases, which comprises 86 rare diseases across various medical specialties including hematology, dermatology, rheumatology & immunology, pediatrics, neurology, and endocrinology.
Sep 21, 2023
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