In 2004 the Japanese government created the Pharmaceuticals and Medical Devices Agency (PMDA), a regulatory body responsible for the oversight of drugs and devices, by consolidating the Pharmaceutical and Medical Devices Evaluation Center of the National Institutes of Health Science, the Organization for Pharmaceutical Safety and Research and part of the Japan Association for the Advancement of Medical Equipment. Four years later, Tatsuya Kondo, a neurosurgeon by training, joined as chief executive at a time of two crises: long review times and a lack of public trust in the organization. A multi-pronged approach has helped alleviate these concerns, he tells Asher Mullard, on the tenth anniversary of the PMDA.
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Tatsuya Kondo. Nat Rev Drug Discov 13, 490 (2014). https://doi.org/10.1038/nrd4376
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DOI: https://doi.org/10.1038/nrd4376
