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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
POLICY
China Promotes the Development of 39 Generics to Meet Domestic Clinical Needs
On Dec 25, 2023, China issued the 3rd list of encouraged generic drugs. The list comprises 39 drugs based on their active ingredients, encompassing a total of 75 different strengths. The foremost purpose for releasing this list is to address the clinical needs within the country.
Dec 27, 2023
POLICY
[Updated] China's 9th Volume-based Procurement (VBP) Includes 195 Products
On Nov 6, 2023, China announced the preliminary results of the bid for the 9th national volume-based procurement (VBP), a bulk-purchase program for supplying medicines to public healthcare institutions. 266 products (41 drugs if classified by active ingredients) from 205 companies won the bid.
Nov 17, 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
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
POLICY
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
