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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
INDUSTRY
MAH Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New Drug
Monthly 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
REGULATION
Law & Regulation Marketing Approval Innovative Drug Generic Drug Drug Registration New Drug
Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case China's IP court rules that Wenzhou Haihe Pharma’s generic drug is outside Chugai Pharma's Patent Claim 1 for the brand-name version of Eldecalcitol Soft Capsules.
Apr 24, 2022
INDUSTRY
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Cardiovascular Disease Rare Disease Drug Registration New Drug
Monthly 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
POLICY
Law & Regulation Marketing Approval Volume-Based Procurement Medical Insurance Innovative Drug Cancer Cardiovascular Disease Rare Disease Drug Registration New Drug
China's 2022 Two Sessions: Goals and Proposals for Pharma & Healthcare Industry China's Government Work Report says one off the major tasks for 2022 is to improve medical and health services.
Mar 15, 2022
INDUSTRY
Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration New Drug COVID-19
Monthly 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
REGULATION
Law & Regulation CDE Guideline Reference Listed Drug (RLD) Marketing Approval DMF Biological Product API Drug Registration New Drug
Monthly 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
REGULATION
Law & Regulation Marketing Approval Priority Review and Approval Innovative Drug Drug Registration New Drug
China to Expedite Marketing Approval of Innovative Drugs China CDE plans to expedite the marketing approval of inovative drugs with Breakthrough Therapy Designation (BTD). Technical review will be completed within 130 workdays for the innovative BTD drugs' marketing applications.
Mar 03, 2022
INDUSTRY
Marketing Approval Innovative Drug Drug Registration New Drug COVID-19
China Approves Pfizer's Paxlovid, Encouraging COVID-19 Drug Development On Feb. 11, China NMPA conditionally granted the emergency approval to Pfizer's co-packaged nirmatrelvir tablets and ritonavir tablets (Paxlovid).
Feb 28, 2022
REGULATION
Marketing Approval Innovative Drug Drug Registration New Drug
China CDE Accepted 11,569 Drug Registration Applications in 2021 From 2016 to 2021, the number of drug registration applications accepted by China Center for Drug Evaluation (CDE) climbed from 3,779 to 11,569.
Jan 18, 2022
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