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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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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
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
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
CMC
Clinical Trial
Generic Drug
OTC Drug
Cell Therapy
New Drug
GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2023
Check out China's pharma regulatory updates in June 2023: 1. NMPA Announces Three Rx-to-OTC Switches; 2. NMPA Releases the 69th RLD List; 3. NMPA Specifies GLP Certification Requirements; 4. NMPA to Make Medication Package Inserts Friendlier to Senior Patients; 5. NMPA Revises Administrative Measures for Drug Inspection; 6. CDE Releases Nine (Three in Effect and Six in Consultation) Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on One Standard on the Generic Names of Pharmaceutical Packaging Materials
Jul 27, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | June 2023
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
Jul 07, 2023
REGULATION
Law & Regulation
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Bioequivalence (BE)
Post-market
Generic Drug
OTC Drug
Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2023
China drug regulatory updates in May 2023: 1. China to Tighten Regulation on Drug MAHs That Outsource Manufacture; 2. China May Disallow ANDAs of Generic Drugs with No RLDs and Low Clinical Value; 3. China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs; 4. China Greenlights One Rx-to-OTC Switch; 5. China Releases Two RLD Lists...
Jun 15, 2023
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