[ NATIONAL · JP ]
A ministry setting the requirements and an agency conducting the scientific review and inspection.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
ASIA-PACIFIC
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices — Act No. 145 of 1960, universally shortened to the PMD Act. It covers pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medicine products in one instrument, which is worth noting on its own: the quasi-drug category has no clean equivalent in the United States or the European Union, and a product that is a cosmetic in one market can be a quasi-drug here with different obligations attached.
Through a licence structure that separates selling from making, and through two authorities with different jobs. The Ministry of Health, Labour and Welfare takes the administrative action — marketing approval for a product is granted by the Minister — while the Pharmaceuticals and Medical Devices Agency performs the review and the post-market safety work. A company needs a marketing business licence to place a product on the market and a manufacturing business licence to make it, and those are separate permissions held by potentially different entities.
WHAT TRANSFERS
Technical evidence travels; the position in the market does not. Japan is an ICH founding region, so a dossier built on harmonised technical requirements is largely intelligible here — but the structural requirement is one no dossier satisfies: a foreign manufacturer cannot hold the market position itself. It is accredited as a foreign manufacturer and must reach the market through a Japanese Marketing Authorization Holder, or through a Japanese manufacturer it appoints. The MAH carries the regulatory obligations in Japan, which makes choosing one a regulatory decision rather than a commercial one.
The marketing business licence and the manufacturing business licence are distinct, and the entity that sells is not necessarily the entity that makes. Structures designed around a single Western-style manufacturing authorisation tend to leave one of the two unaccounted for.
For a foreign manufacturer, the Japanese Marketing Authorization Holder carries the regulatory responsibilities in Japan — the relationship is the compliance architecture, not an import arrangement, and its terms determine who answers to the authority for what.
MHLW takes the administrative and approval action; PMDA reviews and runs post-market safety. Correspondence and commitments should be addressed to the body that actually holds the function in question rather than to whichever name is more familiar.
The PMD Act runs pharmaceuticals, quasi-drugs, cosmetics, devices and regenerative medicine products together, and quasi-drugs sit between medicine and cosmetic with their own requirements. A product classified as a cosmetic elsewhere may not be one here, and classification comes before every other question.
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Act No. 145 of 1960. It is Japan’s principal instrument for pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medicine products — five product categories governed by one statute.
Not directly as a foreign manufacturer. Accreditation as a foreign manufacturer is required for the site, and the product reaches the market through a Japanese Marketing Authorization Holder or a Japanese manufacturer the foreign company appoints. The MAH carries the regulatory obligations in Japan, so selecting one is a regulatory decision.
The Ministry of Health, Labour and Welfare is the administrative authority — marketing approval for a pharmaceutical is granted by the Minister. The Pharmaceuticals and Medical Devices Agency performs the scientific review and post-market safety work. They have different functions rather than different names for the same one.
It means the technical expectations are largely harmonised, so the evidence is broadly intelligible. It does not mean the application is accepted as filed elsewhere, and it does nothing about the structural requirements — the marketing and manufacturing licences, foreign manufacturer accreditation, and the Japanese MAH.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about Japan: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.