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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Marketing Approval Priority Review Innovative Drug Generic Drug Biological Product Drug Registration
Monthly Report: New Drug Approvals in China | January 2024 In January 2024, China NMPA approved 18 new drugs, among which 14 are chemical drugs and 4 are biological products.
Feb 05, 2024
REGULATION
Law & Regulation Innovative Drug New Drug Patent
China to Enforce Revised Rules on Drug Patent Term Compensation The revised Rules on the Implementation of the Patent Law of the People’s Republic of China is set to come into effect on January 20, 2024. The revised Rules includes provisions specifically related to drug patents which are significant for new drug applicants.
Jan 19, 2024
PIPELINE
License in/out
Small Nucleic Acid Drugs Spearhead in BD&L in Early 2024 Chinese biopharmaceutical companies made significant strides in business development and licensing (BD&L) at the beginning of 2024, with three notable deals centered around small nucleic acid drugs/platforms.
Jan 16, 2024
INDUSTRY
Retail Pharmacy Sales in China Experience Rapid Growth in H1 2023 Despite not holding the largest market share, retail pharmacies exhibited the strongest sales growth among the three pharma market terminals in China. Retail pharmacy sales in H1 2023 amounted to CNY 266.8 billion, representing a significant increase of 12.4% compared to H1 2022.
Jan 10, 2024
INDUSTRY
Marketing Approval Innovative Drug Diabetes Drug Registration New Drug
[Updated] GLP-1-RAs Swoop to Chinese Market, Eyeing Diabetes Treatment & Weight Control Needs On July 25, 2023, China National Medical Products Administration (NMPA) approved Beinaglutide Injection (Feisumei), a glucagon-like peptide-1 receptor agonist (GLP-1-RA), for weight loss.
Jan 09, 2024
REGULATION
Law & Regulation Reference Listed Drug (RLD) Generic Drug OTC Drug
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
INDUSTRY
Marketing Approval Priority Review Cancer New Drug
Monthly Report: New Drug Approvals in China | December 2023 In Dec 2023, China NMPA approved 8 new drugs, among which 6 are chemical drugs and 2 are biological products.
Jan 02, 2024
POLICY
NRDL Health Insurance Innovative Drug Rare Disease
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
API Cancer Rare Disease
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
REGULATION
Law & Regulation Pharmacopoeia Marketing Approval Post-market Drug Registration
What Marketing Authorization Holders (MAHs) Should Do About China Drug Standards On July 5, 2023, China National Medical Products Administration (NMPA) issued the Administrative Measures for Drug Standards, which will take effect on the first day of 2024.
Jan 01, 2024
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