Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis
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DOI: 10.1002/cpt.2080
Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and… read more here.
Keywords: drug lag; new drug; drug; japan ... See more keywords
Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States
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DOI: 10.3390/ijerph19052857
Abstract: (1) Background: Drug lag, the delay between the first global regulatory approval and approval by the national health authorities in other countries, impacts the accessibility of drugs. Although the Korean pharmaceutical market has grown significantly,… read more here.
Keywords: approval; drug approval; orphan drugs; drug lag ... See more keywords