Medicines Agency
Generally, a Medicines Agency is a national drug competent authority that is responsible for evaluating medicinal products, granting marketing
authorization and monitoring in the post-authorization phase the drug safety through ongoing pharmacovigilance.
Unlike other regulatory regions, where a single centralized administrative body - FDA, Health Canada, KFDA and similar, has the role of national medicines agency, in Japan the functions of the national medicines agency are shared between three govermental bodies: the Pharmaceutical and Food Safety Bureau of the MHLW, the Pharmaceuticals and Medicals Device Agency (PMDA) and the National Institute of Health Sciences (NIHS).
