Long-acting insulin analogue
Insulin Glargine in Japan: prescription, brands, pricing
This page summarises the situation of Insulin Glargine in Japan under PMDA (Pharmaceuticals and Medical Devices Agency): prescription status, available brands and generics, pharmacy dispensing, and online options in JPY. Insulin Glargine belongs to the Long-acting insulin analogue class.
- Regulator
- PMDA (Pharmaceuticals and Medical Devices Agency)
- Currency
- JPY
About Insulin Glargine
Insulin glargine is approved as basal insulin therapy in adults and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus when oral or non-insulin injectable therapy is insufficient or contraindicated… Japan classifies medicines into prescription drugs (医療用医薬品) and OTC drugs (一般用医薬品), the latter further divided into pharmacist-only (第1類) and self-service classes. The Ministry of Health, Labour and Welfare (MHLW) sets the regulatory framework; PMDA reviews safety and efficacy.
Mechanism and action
Insulin glargine binds the insulin receptor with similar affinity to human insulin, activating intracellular signalling that increases glucose uptake in muscle and adipose tissue, suppresses hepatic glucose production and promotes lipogenes…
Brands and generics in Japan
In Japan, Insulin Glargine is typically dispensed as one internationally recognised brand along with their corresponding authorised generics. Japanese pharmacies (薬局) and drugstores (ドラッグストア) such as Matsumoto Kiyoshi and Welcia are widespread. Prescription dispensing pharmacies (調剤薬局) are usually located near hospitals and clinics; pharmacist counselling at dispensing is mandated by the Pharmaceutical Affairs Law. Brand-to-generic substitution is decided by the pharmacist under local PMDA (Pharmaceuticals and Medical Devices Agency) equivalence rules, and the price difference in JPY is usually substantial.
Online and tele-prescribing access
Japan permits online sale of most OTC medicines under the 2014 amendments to the Pharmaceutical Affairs Law, with class-based restrictions. Online prescription dispensing is allowed via licensed pharmacies after a face-to-face or telemedicine consultation; personal importation of prescription medication is restricted to limited quantities for personal use. For Insulin Glargine specifically, the legal online options in Japan depend on its Rx-or-OTC classification under PMDA (Pharmaceuticals and Medical Devices Agency).
Frequently asked questions
Is Insulin Glargine available in Japan? ▾
Yes — Insulin Glargine and its brands are available in Japan through pharmacies authorised by PMDA (Pharmaceuticals and Medical Devices Agency), in various strengths depending on the commercial product. Authorised generics offer a lower-cost alternative with the same active substance.
Do I need a prescription for Insulin Glargine in Japan? ▾
Japan classifies medicines into prescription drugs (医療用医薬品) and OTC drugs (一般用医薬品), the latter further divided into pharmacist-only (第1類) and self-service classes. The Ministry of Health, Labour and Welfare (MHLW) sets the regulatory framework; PMDA reviews safety and efficacy. The exact status of Insulin Glargine (Rx or OTC) is determined by PMDA (Pharmaceuticals and Medical Devices Agency); most active ingredients in the Long-acting insulin analogue class require prescription, although there are exceptions by country and formulation.
How much does Insulin Glargine cost in Japan? ▾
The price in JPY depends on the manufacturer (brand vs authorised generic), the strength and the pack size. Generics are typically substantially cheaper than brands and serve as the economic reference for ongoing use.
Products with Insulin Glargine in Japan
Insulin Glargine in other countries
The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.