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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China Starts Implementing the 2023 National Reimbursement Drug List (NRDL)
On Dec 13, 2023, China published the 2023 National Reimbursement Drug List (NRDL), which is set to take effect on the first day of 2024. The updated 2023 NRDL includes a total of 3,088 drugs, with 126 new additions and the removal of one drug, Elbasvir and Grazoprevir Tablets.
Jan 01, 2024
POLICY
China Waives Import Tariffs for Active Ingredients of Anti-cancer and Rare Disease Drugs in 2024
China will waive import tariffs for 62 active pharmaceutical ingredients (API) of anti-cancer drugs and 5 APIs of rare disease drugs, starting from Jan 1, 2024. Medical products such as nirmatrelvir for COVID-19, insulins for diabetes, vaccines, gene therapies, and more will also enjoy interim zero tariffs.
Jan 01, 2024
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
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
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
REGULATION
Law & Regulation
Guideline
Marketing Approval
Priority Review
NRDL
Health Insurance
Rare Disease
Drug Registration
Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable
This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
POLICY
China Levies Zero Tariff on Active Pharmaceutical Ingredients of COVID-19, Cancer, and Rare Disease Drugs
According to China's 2023 Tariff Adjustment Plan, tariffs are provisionally lowered to zero for 22 categories of active pharmaceutical ingredients of medicines for treating COVID-19, cancer, and rare diseases.
Jan 05, 2023
INDUSTRY
MAH
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Diabetes
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | August 2022
In August 2022, China NMPA approved 13 new drugs, including 9 chemical drugs and 4 biological products. Among them, MSD's HPV 9-valent vaccine got approval to expand the target group from females 16-26 years of age to 9-45 years of age.
Sep 09, 2022