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
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
Law & Regulation Marketing Approval Volume-Based Procurement Medical Insurance Innovative Drug Cancer Cardiovascular Disease Rare Disease Drug Registration New DrugChina'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
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
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
China Adds 74 Drugs to National Reimbursement Drug List (NRDL) On Dec. 3, China released its 2021 National Reimbursement Drug List (NRDL). NRDL is a list of drugs allowable for reimbursement by the national social health insurance fund under the social security system which has covered more than 1.36 billion people in China by the end of 2020.
Dec 08, 2021
China's 2020 National Reimbursement Drug List Includes 119 Additional Drugs China's National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the 2020 Edition of the National Reimbursement Drug List (NRDL) on Dec. 28, 2020, which will take effect on Mar. 1, 2021.
Mar 08, 2021
China to Exempt Import Tariffs on 61 Active Pharmaceutical Ingredients for Anticancer and Rare Disease Drugs China will apply interim import tax rates that are lower than most-favored-nation tariffs on 883 kinds of goods from Jan. 1, 2021, according to the 2021 Tariff Adjustment Plan issued by the Customs Tariff Commission of the State Council on Dec. 23, 2020.
Mar 08, 2021
China's Social Medical Insurance to Cover More Drugs for Rare Diseases On Dec. 28, 2020, the National Healthcare Security Administration and Ministry of Human Resources and Social Security issued the 2020 Edition of the National Reimbursement Drug List (NRDL).
Mar 08, 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