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
Evolving Research and Development Landscape for Rare Diseases: Growing Concerns Over Orphan Drug Lag in Japan
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DOI: 10.1002/cpt.3553
Abstract: Patients with rare diseases worldwide face substantial unmet therapeutic needs. In Japan, drug lag—delays in drug approval compared to other countries—has resurfaced as a pressing public health issue. This study analyzes orphan drugs (ODs) approved… read more here.
Keywords: rare diseases; drug; development; 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