Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New DrugMonthly Report: New Drug Approvals in China | April 2022 In April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
May 12, 2022
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Cardiovascular Disease Rare Disease Drug Registration New DrugMonthly Report: New Drug Approvals in China | March 2022 In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New Drug COVID-19Monthly Report: New Drug Approvals in China | February 2022 In February 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products. Among the newly approved drugs, Pfizer’s Paxlovid is the first foreign drug against COVID-19 to receive marketing authorization in China.
Mar 11, 2022
Law & Regulation CDE Guideline Reference Listed Drug (RLD) Marketing Approval DMF Biological Product API Drug Registration New DrugMonthly Recap: China Pharmaceutical Regulatory Updates | February 2022 1. CDE Releases its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial); 2. CDE Consults on the Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs; 3. CDE Releases the Consultation Draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial); 4. NMPA Releases the 51st List of Reference Listed Drugs; 5. NMPA Publishes the 2022 Plan for Random Inspection of Medical Devices; 6. NMPA Reveals the List of 208 Medical Devices Approved in January 2022; 7. Guidelines for Pharmaceutical Industry.
Mar 10, 2022
Are Cross-Border Licensing Deals a Shortcut to China's Pharma Market? In 2021 H1, China has made 50 in-licensing deals, among which the top 10 add up to $5,197.5 million in value. Licensing deals do have advantages for promoting foreign drugs in China, but they are not shortcuts. Prudent work still needs to be done before making the deals.
Dec 07, 2021
China's Insulin VBP Saw Average Price Cut of 48.75% China’s insulin VBP (volume-based procurement)--eleven drug makers won the bid to supply insulin products to public healthcare institutions across China. Among 42 bid-winner products, Novo Nordisk took the champion with seven products. Two local Chinese companies—Gan & Lee and the United Laboratories—took the second and third places with six products respectively.
Dec 06, 2021
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Biosimilar Drug Registration New DrugMonthly Report: New Drug Approvals in China | Oct. 2021 In Oct. 2021, China's NMPA granted marketing authorization approvals to 11 new drugs, including Takeda's VOCINTI and Sanofi's Clopidogrel Bisulfate and Aspirin Tablets.
Nov 08, 2021
NMPA-Approved Injectable Fillers in China's Market China’s promising injectable filler market is expected to witness other new products' emergence. The market size is predicted to grow from US$ 603.8 million in 2019 to US$ 1,063.53 million by 2026. Meanwhile, China tightens the regulation on aesthetic medical products or practices so injectable fillers and relevant businesses won’t be an exception.
Nov 04, 2021
- How to Sell OTC Drugs to China Through Cross-Border E-Commerce
- China NMPA Announces Key Points for Pharmacovigilance Inspections
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- China Implements New Rules on Drug MAH's Annual Reports
- Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case