Japan Market · Licensing & Advertising Compliance

Which licence you need is one question.
What you may then say about the product
is a different one. Both stop launches.

I am a licensed Japanese pharmacist. I advise on which route your plan requires in Japan — wholesale distribution, marketing authorisation, cosmetics, foods — and what holding it obliges you to do. Then on the part almost everyone underestimates: what you are legally allowed to say about the product once you have it. I advise on which route to take and what it requires; I do not file on your behalf or act as your Marketing Authorisation Holder.

The problem

An accurate translation can still be an illegal one.

The usual sequence: a brand completes its notification, launches in Japan, and hands its English marketing deck to a translator. The Japanese comes back faithful to the original. It is also, quite often, a violation — and the failure is almost never bad faith. It is a claim that is completely ordinary in its home market and has no legal room to exist in Japanese.

Japan regulates health claims through several statutes at once, and the categories do not map onto FDA, EFSA or MHRA equivalents. A supplement is a food until its ingredients or its claims push it into quasi-drug or drug territory — and the claim alone is enough to move it. Cosmetics may only say what is on a closed list. None of this is discoverable by reading your own label carefully; it depends on notices that are issued in Japanese and updated continuously.

There are established consultancies that handle Japanese regulatory work, several of them well, and if you need someone to file as your agent or to hold the marketing authorisation, you should use one. What I offer is different in kind: one licensed pharmacist, working through your route and your copy personally, against a rule set I maintain and can show you.

Act on Pharmaceuticals and Medical Devices (PMD Act)
Act against Unjustifiable Premiums and Misleading Representations
Health Promotion Act
Act on Specified Commercial Transactions
Standards for Fair Advertising of Drugs
Foods with Function Claims (notified claims)
56 permitted cosmetic efficacy expressions
Five examples

Phrases that are unremarkable in English and unusable in Japanese.

These are not edge cases. They are the five I see most often in copy that has already been translated, approved internally, and published.

01 — "Clinically proven"
For a food, a clinical-efficacy claim is only available if the product is a notified Food with Function Claims, and then only within the exact wording of the notification. An ordinary food cannot borrow the credibility of a study, however real the study is. Citing your own trial does not create the entitlement.
02 — "Anti-aging"
Cosmetics in Japan may only claim from a closed list of 56 permitted efficacy expressions. Reversing or preventing ageing is not on it. "Age-defying care" — care appropriate to one's age — is the accepted formulation, and it carries a footnote requirement. The distinction looks cosmetic in English. It is the whole thing in Japanese.
03 — "Doctor recommended"
Endorsement by physicians, pharmacists and other healthcare professionals is prohibited in principle under the fair-advertising standards, on the reasoning that the public cannot evaluate the endorsement. This surprises overseas brands more than any other rule, because it is a selling point almost everywhere else.
04 — "#1 in the US"
A superiority claim needs a reasonable basis, and Japan's regulator has set four conditions: an appropriate comparison set, appropriate survey respondents, a fair method, and — the one that catches people — correspondence between what the survey measured and what the ad says. Citing the source is not sufficient. Noting that it was an image survey does not cure it.
05 — "Beauty ingredient"
When a cosmetic names an ingredient, it must state why the ingredient is there, and the stated purpose must sit inside the permitted efficacy range. As of the July 2026 revision to the industry advertising guideline, "beauty ingredient" and "skin-beautifying ingredient" are listed as unacceptable purposes. "Moisturising ingredient" is fine. The vocabulary changed; most pages have not.
Bonus — the subscription checkout
If you sell on subscription, the final confirmation screen is separately regulated. Showing one month's quantity for a five-month commitment does not count as disclosing the quantity. A cancellation phone number that does not actually connect can itself be a misrepresentation. This one is invisible in an ad review, because it lives in your cart software.

Each of the above corresponds to entries in the rule database described below, with the underlying notice or report cited. Happy to share the specific citations on request.

Licensing

Which route your plan requires, and what holding it obliges you to do.

Some of what reaches me is earlier than advertising. A company wants to move pharmaceutical products into or through Japan and needs to know which licence the plan requires, whether the plan is even available in that form, and what the licence will oblige them to do every day afterwards. I answer that question, and I build the documents the licence obliges you to hold. I do not file the application as your agent and I will not hold the authorisation for you.

Wholesale distribution licence
Buying and selling pharmaceuticals inside Japan, business to business. The lightest route that still carries a real licence, and usually the right first step for a company that wants a Japanese supply chain before it wants a Japanese product. The four things that decide whether it is feasible for you are set out below.
Marketing authorisation
Required to import a product and place it on the Japanese market under your own name. It carries three statutory officers — the supervising officer must be a pharmacist and must be full-time — plus GQP and GVP conformity as a condition of the licence, a manufacturing licence for the storage site, accreditation of the foreign manufacturer, and approval of each individual product. Substantially heavier than most overseas plans assume, which is why the usual advice is to take the wholesale route first and separate the import question into its own stage.
Cosmetics, quasi-drugs, foods
A different track again, with its own notification and its own limits on what may be said afterwards. Most of my work sits here, and the claim side of it is the rest of this page.

The wholesale licence in detail, because it is the one I am asked about most and the one where the obstacles are physical rather than procedural.

A pharmacist, full-time, at that office
Every office must have a manager who is a pharmacist and who is actually present there. They may not simultaneously practise pharmaceutical work at another site unless the prefectural governor permits it. They owe the operator written opinions, and copies are kept three years. In practice this is a hire, not an arrangement you can make on paper.
Premises of at least 100 m²
A hundred square metres including storage, excluding living space, unsanitary areas and shared corridors. Sixty lux or more where product changes hands, cold and dark storage where the product needs it, locked storage if you handle poisons, and the storage area clearly separated from the rest. This is the first bottleneck for almost every overseas plan, and it is a property search rather than a form.
Who you are permitted to sell to
Fixed by statute: pharmacies, manufacturers and marketing authorisation holders, other wholesalers, hospitals, clinics and veterinary clinics. Store-based retailers may be sold only OTC and pharmacist-guidance products; household distributors, only OTC. Consumers are not on the list. If your plan ends at a Japanese consumer, this is not the licence, and that is worth settling in the first conversation rather than the fourth.
Records, down to the lot number
For every purchase and every sale: product name, lot number, expiry date, quantity, date, the counterparty's name, address and contact details, the documents you were shown to verify them, and evidence that the individual handling the transaction works for the counterparty. Kept three years. This came in after the 2017 falsified-product incident, and it is the requirement overseas operators consistently underestimate — it is a system and a daily routine, not a spreadsheet.
A written operating system
A compliance policy and procedures, a reporting route for incidents, named individuals permitted to enter the storage area, training with evaluation, internal rules, and documented authority for the responsible officers. The manager's written opinions must be respected, and the measures taken — or the reason none were needed — recorded and kept.
Six years, and not portable
The licence runs six years. Moving the office, or a change of operator through merger or transfer of the business, means a fresh licence rather than an amendment. Worth knowing before you sign a lease on the hundred square metres.
What I actually deliver here. Which route your plan requires and whether it is available in that form; the requirements it carries and what satisfying each one will cost you in people, premises and time; and then the document set the licence obliges you to hold — procedures, record-keeping design, training, the manager's reporting line. That last part is the deliverable, and it is the same work whether you file yourself or through an agent. Each point is given with the governing article, in English, so your side can check me against the statute rather than taking my word for it.
Who I am

A pharmacist, not an agency.

I am Masa, a pharmacist licensed in Japan. I have worked on advertising and labelling review for health foods, supplements, cosmetics, quasi-drugs and medical advertising since 2017 — roughly a thousand reviews. I have also dealt directly with a public health centre on a pharmacy’s distance-selling notification and the operating systems behind it, which is where the licensing side of this page comes from: the requirements read differently once you have had to satisfy an inspector rather than read a statute. Every review is done by me. There is no account manager between you and the person making the judgement.

Licensed pharmacist (Japan)
Pharmaceutical Affairs Law Manager
Premiums & Representations Act, Grade 1
YMAA / KTAA certified
Cosmetics Pharmaceutical Affairs Manager
I maintain my own rule database. It currently holds 849 entries, each tied to a primary source — a ministry notice, an agency report, a cease-and-desist order — and each updated when the source moves. It is not a keyword blocklist. It exists because Japanese advertising rules change through notices rather than statutes, and a review written against last year's understanding is worth very little. The July 2026 cosmetics guideline revision in example 05 was in the database within weeks of publication.
Scope

What I do, and what I deliberately do not.

I do
Licensing advice: which route your plan requires — wholesale distribution, marketing authorisation, cosmetics, foods — what it obliges you to have, and whether the plan works in that form at all.

The documents the licence requires you to hold: procedures, record-keeping design, training, the responsible person’s reporting line.

Review of Japanese-market copy — landing pages, packaging, Rakuten and Amazon listings, ads, influencer briefs — against the applicable statutes, returned as a specific rewrite rather than a list of objections.

Pre-launch claim scoping: what this formulation can and cannot say in Japan, before the creative is made.

Ongoing review as notices are issued and copy changes.
I do not
File on your behalf, or act as your Marketing Authorisation Holder. I advise on which route to take and what it requires; I do not submit the application as your agent and I will not hold the authorisation or serve as your resident officer. Those are separate undertakings carrying their own liability, and the firms that do them do them properly.

Where you need a filing agent or a resident MAH, I will say so and tell you what to ask them for. That is usually a much shorter conversation once the route and the requirements are settled — which is the part I am there for.
Working language and format. Everything is delivered in writing, in English, over email or a shared Slack channel. This is a design decision, not a limitation: a compliance judgement that is not written down is not usable later — by your team, by your agency, or by a regulator asking how you arrived at the claim.
Contact

Send me a page and I will tell you what is wrong with it.

The fastest way to judge whether this is useful is to give me something real. Send one Japanese landing page, product page or label, and I will return a short review of it — the specific lines, the statute each one touches, and what you could say instead. No charge for the first one.

If you already work with a regulatory consultancy and want a second read on the Japanese copy specifically, that is a normal thing to ask for and I am happy to work alongside them.

[email protected]

M.and.A.works · Japan · Replies in English, usually within two business days.

Please note

This page describes general regulatory considerations for the Japanese market and is not legal advice, nor a guarantee that any particular expression will be accepted by a regulator, a platform or a media reviewer. Final responsibility for what is published rests with the advertiser. Where a matter requires legal representation, I will say so and refer you on. Statutory names are given in their common English renderings; the governing text is the Japanese original.