Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New DrugChina 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
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 Marketing Approval Clinical Trial Priority Review and Approval NRDL Volume-Based Procurement Medical Insurance Innovative Drug API Rare Disease New DrugThe 15th Rare Disease Day: China's Policy & Market Overview China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022
Law & Regulation Marketing Approval Priority Review and Approval Innovative Drug Drug Registration New DrugChina 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
Biogen's Drug for Rare Disease SMA Gets Access to More Patients in China Due to NRDL In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose to get a place in China’s National Reimbursement Drug List (NRDL). The move makes Spinraza gain access to more spinal muscular atrophy (SMA) patients in China.
Feb 14, 2022
Law & Regulation Reference Listed Drug (RLD) Marketing Approval Priority Review and Approval Innovative Drug Generic Drug Drug Registration New DrugHow Will China Regulate and Boost Pharmaceutical Industry by 2025 At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
Law & Regulation Pharmacopoeia MAH Pharmacovigilance Marketing Approval Priority Review and Approval Volume-Based ProcurementTop 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
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
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- 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