Pharmaceuticals and Medical Devices Agency

Administers Pharmaceuticals and Medical Devices Agency as Japan's national regulator for medicines, devices, and regenerative therapies.

PMDA (Pharmaceuticals and Medical Devices Agency) is Japan's national regulatory authority for drugs, medical devices, and regenerative medical products — the Japanese counterpart to the US FDA and EU EMA. Established in 2004 as an independent administrative institution (独立行政法人) under the Ministry of Health, Labour and Welfare (MHLW), PMDA carries out reviews, consultations, compliance assessments, post-market safety surveillance, and adverse-reaction relief services. PMDA does NOT issue grants or provide financial awards to external parties. Its funding model is the inverse of a grant funder: pharmaceutical and medical device companies pay user fees to PMDA in exchange for regulatory review services. Researchers and companies seeking Japanese medical research grants should contact AMED (Japan Agency for Medical Research and Development, fid 49) instead.