Ministry of Health, Labour and Welfare (MHLW), with the Pharmaceuticals and Medical Devices Agency (PMDA) doing the scientific review and safety monitoring
Is Pramlintide legal in Japan?
Not approvedNo marketing approval in Japan; pramlintide (an amylin analogue) is not in PMDA's approved-drug lists or package-insert database
Not approved as a medicine here.
PMDA's approved new drug lists (April 2004 to September 2026) and its package-insert database return no pramlintide product, so it is not an approved medicine in Japan. We did not look for an unapproved-use notice specific to pramlintide. Under the PMD Act a drug needs MHLW approval (Art. 14) before it is marketed, selling one marketed without approval is prohibited (Art. 55(2)) and advertising it is banned (Art. 68).
Last verified 2026-09-29 · how we verify
Pramlintide elsewhere
Sources (4)
- 01Approved new drugs list (Japanese), fiscal 2026 to date, covering approvals from May to September 2026 (承認品目一覧（新医薬品）)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09 · accessed 2026-09-29
- 02List of Approved Drugs, April 2004 to February 2026 (new drugs)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026 · accessed 2026-09-29
- 03Prescription drug package insert and review report search (医療用医薬品 添付文書等情報検索)Pharmaceuticals and Medical Devices Agency (PMDA) · 2026-09-29 · accessed 2026-09-29
- 04Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), consolidated textDigital Agency (e-Gov Law Search) · 2026-05-21 · accessed 2026-09-29