Selling cosmetics in Japan: the MAH licence, quasi-drugs and labelling

The PMDL (薬機法, Yakukihō) is the primary statute governing pharmaceuticals, quasi-drugs, cosmetics and medical devices in Japan. It replaced the older Pharmaceutical Affairs Law in 2014. For cosmetic brands the practical implications are three: only a Japanese-established Marketing Authorization Holder can place product on the market, every ingredient must comply with the positive and negative lists maintained by MHLW, and any functional claim above basic cosmetic scope reclassifies the product as a quasi-drug with a separate approval route.

Japan classifies personal care products into three tiers, and the tier determines the route to market:

• Cosmetics (keshōhin). Standard cosmetics with mild action on the body. No pre-market approval, but the MAH must notify MHLW and ingredients must respect the positive and negative lists.
• Quasi-drugs (iyakubugaihin). Products with a stated functional effect: whitening, anti-acne, anti-dandruff, deodorant, hair growth, medicated toothpaste. These require pre-market approval per product and per claim, typically taking 6 to 12 months.
• OTC drugs (ippan'yō iyakuhin). Treated as pharmaceuticals, outside the typical cosmetic remit.

A single formulation can sit in different tiers depending on the claim made on pack. Reviewing claims market by market is therefore a regulatory task, not a marketing one.

The MAH (製造販売業者, seizō hanbai gyōsha) is the licensed Japanese entity legally responsible for the product on the Japanese market. They hold the manufacturing and marketing license, sign off on release, handle vigilance and recalls, and are the single point of accountability for MHLW and the PMDA. Foreign brands cannot self-import directly: you either set up a Japanese subsidiary with an MAH licence, or appoint a third-party MAH (D MAH, designated marketing authorisation holder) to act on your behalf. The MAH must maintain GQP (good quality practice) and GVP (good vigilance practice) systems.

Japan operates a hybrid ingredient regime. There is a negative list of prohibited substances and a restricted list with limits per category (rinse-off, leave-on, eye area, mucous membrane). On top of that, certain ingredient classes (UV filters, preservatives, colourants) have a positive list, meaning only substances on the list at the stated concentration are permitted. Anything outside the positive list for those categories needs a quasi-drug or pre-market approval route. Ingredient names on pack must follow the Japanese Cosmetic Ingredient Codex (JCIC) names maintained by the JCIA, not raw INCI.

All mandatory information must appear in Japanese on the immediate container or outer packaging. The core elements are:

• Product name
• Name and address of the MAH
• Manufacturing lot or batch number
• Full ingredient list in JCIA Japanese names, in descending order of weight (with the standard 1% threshold for unordered listing)
• Net content
• Use-by date where stability is under three years or where required by category
• Mandatory warnings for restricted ingredients

Bilingual labelling is permitted as long as the Japanese version is at least as prominent as any other language. Claim wording is scrutinised against the cosmetic vs quasi-drug boundary, so wording such as "whitens" or "prevents dandruff" effectively pushes a product into the quasi-drug tier.

Japan entry stalls on sequencing rather than on any single requirement. The MAH licence gates everything downstream, and quasi-drug approval runs on a different clock to cosmetic notification. This is the order of operations.

Note the dependency in rows three and four: the claim decides the route, and the route decides whether launch is weeks or a year away. Screening claims at formulation stage rather than at artwork stage is the single biggest lever, and it is the reason Japan status belongs on the same product record as the EU and US filings inside cosmetic ERP software.

Running Japan in parallel with EU, UK and US cosmetic regimes means the same approved formula must produce four different submissions, with different ingredient names (INCI vs JCIA), different responsible parties (RP vs MAH) and different label artwork in different languages. Done from spreadsheets and PDFs, a single reformulation drags weeks of regulatory rework across markets.

Cosmetic regulatory software collapses this into one cosmetic master per product with regulatory overlays per market. PMDL classification (cosmetic vs quasi-drug), JCIA ingredient mapping, MAH ownership and Japanese label artwork sit alongside the EU PIF and US MoCRA listing, so one change triggers the right downstream actions everywhere.

• One formula, parallel PMDL, CPNP, SCPN and MoCRA overlays
• INCI to JCIA name mapping with positive and negative list checks
• Quasi-drug claim screening at formulation and artwork stage
• MAH and Responsible Person ownership tracked per market
• Multilingual artwork-ready data feeds for Japanese pack

Most cosmetic businesses now manage four parallel regimes: EU, UK, US (MoCRA) and Japan. The shape is similar (responsible person or equivalent, ingredient lists, labelling, vigilance) but the detail differs at every step: PIF vs PIP vs Japanese product file, INCI vs JCIA names, RP vs MAH vs Responsible Person vs no equivalent. The pragmatic answer is one cosmetic master per product with regulatory overlays per market, so a reformulation triggers the right downstream actions automatically. This is how Worldover handles Japan alongside the other major regimes.