Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan

摘要: This paper describes recent developments in licensing and reimbursement policies the EU, US Japan, examines causes of changes, compares differences projects trends. With respect to licensing, EMA, FDA PMDA are committed rigorous evaluation pharmaceuticals advance market access with feedback from post-market experience. The EMA is exploring integrated adaptive pathways for formal pilot tests provide a practical proof concept. augmenting traditional procedures through reforms including Breakthrough Product Designation. implementing foster innovation earlier patient its Sakigaki strategy on regenerative medicines. reimbursement, several generalizations emerge. Relative counterparts, EU payers typically set higher standards evidence effectiveness as condition impose tougher limits by indication, drive harder deals negotiations over prices. article protected copyright. All rights reserved.