An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).

Mahanjit Konwar,Mitesh R Maurya, Tushar B Nishandar,Urmila M Thatte,Nithya J Gogtay

Perspectives in clinical research（2021）

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摘要

Our study shows a significant drug lag between India and other three developed nations (US, EU, and Japan). However, in some therapeutic areas, Indian regulator has proactively approved new drugs much before other agencies. The New Drugs and Clinical Trials Rule of 2019 has brought hope for reduction in drug lag in the near future.

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关键词

Absolute drug lag,Central Drugs Standard Control Organization,European Medicines Agency,Pharmaceuticals and Medical Devices Agency,United States Food and Drug Administration,relative drug lag

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