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- Title
Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective.
- Authors
Asano, K; Tanaka, A; Sato, T; Uyama, Y
- Abstract
Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.
- Subjects
GOVERNMENT agencies; CLINICAL trials; DRUG development; NONCITIZENS; DRUG approval
- Publication
Clinical Pharmacology & Therapeutics, 2013, Vol 94, Issue 2, p195
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/clpt.2013.106