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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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INDUSTRY
Jan 10, 2024
INDUSTRY
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2023
Check out the pharma regulatory updates in Dec 2023: 1. China Encourages the Development of 39 Generic Drugs; China CDE Updates eCTD Structure for Drug Registration Applications; 3. China Releases the 74th List of Reference Drugs...
Jan 04, 2024
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
PIPELINE
Chinese Antibody-drug Conjugates (ADCs) Licensed Overseas Exceeds $23 Billion This Year
On Dec 20, 2023, Hansoh Pharma, a Chinese biopharma company, announced that it had reached an exclusive deal with GSK for HS-20093, an antibody-drug conjugate (ADC) targeting B7-H3. This deal is one of 15 cross-border licensing deals inked this year between Chinese ADC-focused companies and multinational corporations this year.
Dec 21, 2023
REGULATION
China CDE Updates eCTD Structure for Drug Registration Applications
On Dec 11, 2023, China CDE announced updates regarding the electronic submission of drug registration applications. These updates are compiled into the Technical Requirements for Compact Disks Containing Application Dossiers and Electronic Common Technical Document (eCTD) Structure. In addition, CDE has also introduced the eCTD Validation Criteria as a regulatory document. These three documents will come into effect on March 1, 2024.
Dec 18, 2023
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