A brand sends a Japanese factory a one-page brief for a “brightening serum” and asks for a quotation. The factory replies with a question instead of a price: is this a cosmetic or a quasi-drug? The brand had not thought of it as a choice. In Japan it is the first choice, because the words you want on the label decide the legal category, and the category decides which licence the factory needs, whether the product needs an approval, and what the brief has to contain. This article shows you how to make that call before you ask for a quotation.
💬 Sunsho Trade manages own-brand cosmetics made at a GMP-certified partner factory in Japan for brands outside Japan, in English from brief to shipment. Send us the claims you want and we will tell you which side of the line they fall on, or start at the Japan cosmetics OEM guide.
Why the factory asks “cosmetic or quasi-drug” before anything else
Japan’s PMD Act puts cosmetics and quasi-drugs in two separate legal categories with different licences and different market routes, so a factory cannot plan production or price a product until it knows which one it is making.
Japan’s Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act, 医薬品医療機器等法) defines a cosmetic in Article 2(3). In short, a cosmetic is something applied to the body by rubbing, sprinkling or a similar method to clean, beautify, increase attractiveness, alter the appearance, or keep the skin or hair healthy, and its action on the body is mild. The same definition excludes quasi-drugs and anything also intended for a medical purpose. Soap, shampoo and toothpaste sit inside the cosmetic definition.
Quasi-drugs (医薬部外品) are defined separately, in Article 2(2). Many of them look and feel exactly like cosmetics. In Japan they are often sold as “medicated cosmetics” (薬用化粧品). The difference is not the texture or the bottle. It is the purpose the product is presented for, which in practice means the claim.
For a factory this matters in three concrete ways:
- Licence. Japanese manufacturing licences are issued per site and per category. For cosmetics the categories are a general category and a packaging, labelling and storage category. For quasi-drugs there are sterile, general and packaging categories. A site licensed for cosmetics is not automatically licensed for quasi-drugs.
- Market route in Japan. A cosmetic needs a product notification (化粧品製造販売届) before it is marketed in Japan. A quasi-drug needs a product-by-product marketing approval (製造販売承認).
- Development work. A quasi-drug claim depends on an approved active ingredient and on the product approval. That changes what the formula, the data and the timetable look like.
Checked against the published texts of the Ministry of Health, Labour and Welfare, the Saitama Prefecture licensing guidance and JETRO on 17 October 2026.
The claim decides the category — not the ingredient list
Start from the sentence you want on the front of the pack; if that sentence describes an effect Japan reserves for quasi-drugs, the product is a quasi-drug project, whatever the formula looks like.
Brands usually start from ingredients. Japanese practice starts from what the product is for, as stated on the label, in the product name and in advertising. Two bottles with an identical formula can fall into different categories because one says something the other does not.
The typical quasi-drug territory for cosmetic-type products is well defined. The table below sets out where common brand requests fall. The left column is the claim as a brand tends to phrase it; the right column is how Japan treats it.
| What the brand wants to say | How Japan treats it | What that means for the project |
|---|---|---|
| Moisturising, prevents dryness, keeps skin healthy | Within the cosmetic efficacy range | Cosmetic. Product notification for Japan; no product approval |
| Whitening, in the sense of suppressing melanin production to prevent spots and freckles | Quasi-drug claim | Needs an approved active ingredient and product approval |
| Prevents acne as an active effect | Quasi-drug claim | Quasi-drug route. Note that “(by cleansing) prevents acne” for face washes is a cosmetic claim |
| Wrinkle improvement | Exists in Japan only for approved quasi-drugs | Quasi-drug route |
| Makes fine lines caused by dryness less noticeable | Cosmetic claim (item 56), with a testing condition | Cosmetic, but the responsible company must confirm the effect through testing |
| Anti-dandruff medicated shampoo | Quasi-drug category | Quasi-drug route. Some dandruff wording exists for cosmetics too |
| Deodorant, antiperspirant | Quasi-drug category | Quasi-drug route |
| Hair growth, permanent hair dye, perm | Quasi-drug category | Quasi-drug route. A colour product that only coats the hair may be a cosmetic; confirm with the factory |
| Bath additive with stated effects | Quasi-drug category | Quasi-drug route |
The middle column is the part to be careful with. “Whitening” and “wrinkle improvement” are not promises a label can make freely. In Japan they are regulatory categories: a quasi-drug may carry wording of that kind only because an approved active ingredient and a product approval stand behind it. A cosmetic cannot borrow the wording by adding a fashionable ingredient.
The full list of what a cosmetic label may say is covered in our article on Japan’s 56-item cosmetic efficacy range. Use it as the test: if every sentence you want fits that range, you are writing a cosmetic brief.
What changes when you choose the quasi-drug route
Choosing quasi-drug adds a product approval, a specific licence category at the factory, and an active-ingredient decision to the project, so it should be a deliberate choice made before samples, not something discovered after.
Neither route is better. They are different jobs. The comparison below is what a brand should look at when deciding.
| Point | Cosmetic | Quasi-drug |
|---|---|---|
| Legal basis | PMD Act Article 2(3) | PMD Act Article 2(2) |
| Before marketing in Japan | Product notification (化粧品製造販売届) | Product-by-product marketing approval (製造販売承認) |
| Factory licence category | Cosmetics: general, or packaging, labelling and storage | Quasi-drugs: sterile, general, or packaging |
| What the label may claim | Only effects within the 56-item efficacy range | Effects tied to the approved active ingredient and approval |
| Ingredient labelling in Japan | Full ingredient list required | Not under the same full-listing obligation; active and other ingredients listed separately under the industry’s voluntary standard |
| Who controls the timing | The brand and the factory | The approving authority, for the approval step |
Two points need saying plainly. An approval timetable belongs to the authority, so nobody can promise you a date. And Japan separates the company that places a product on the market, which holds a marketing authorisation holder licence (製造販売業許可), from the site that makes it, which holds a manufacturing licence (製造業許可). Neither licence alone is enough, and both must cover the right category.
If you want to sell in Japan itself, the licensing questions are covered in importing cosmetics into Japan. For export, the next section is the part that matters.
Exporting from Japan does not make the category disappear
Even if the product will never be sold in Japan, it is still manufactured in Japan under a Japanese licence, so the Japanese category frames the factory’s work and the Japanese-side documents.
A common assumption is that Japanese categories only matter for Japanese shops. That is not how the manufacturing side works. JETRO’s guidance on exporting cosmetics explains that a product made to an export-only specification from the start — formula or packaging designed for export — needs a cosmetics manufacturing licence and an export manufacturing notification (輸出用化粧品製造届) filed before manufacture starts. Changing the labels of a domestic product for export, for example translating them or redesigning the container or box, also counts as manufacturing. The notification goes to the Minister of Health, Labour and Welfare through PMDA, under Article 74 of the PMD Act Enforcement Order and Article 265 of the Enforcement Regulations.
That procedure is written for cosmetics. If your product is a quasi-drug in Japanese terms, the export procedure and the licences involved are different, and you should confirm them against the current text before you rely on any assumption. In practice, the factory will plan the project inside whichever Japanese category it belongs to.
The category also shapes the certificates you can obtain later. Japan’s export certificates for cosmetics are handled through the Japan Cosmetic Industry Association. A certificate that a named product is manufactured and sold in Japan presupposes that the product is notified for the Japanese market. The full picture is in our article on Japan-side export documents and certificates.
Your destination market has its own categories. A product that is a cosmetic in Japan may be classified differently where you sell it, and the reverse is also possible. Your importer files the destination notification and should tell you which category the authority there will apply. We prepare the Japan-side documents. For Vietnam, see Vietnam’s cosmetics import notification.
💬 Planning a product for export and unsure whether the Japanese side will treat it as a cosmetic? Send us the product name, the claims and the destination market and we will set out the Japanese route before any sample is made.
How the decision shapes your brief
A cosmetic brief lists claims that sit inside the efficacy range; a quasi-drug brief names the intended effect category and accepts the approval step — and either brief should state the decision in its first line.
A factory quotes faster and more accurately when the brief answers the category question for it. Here is what to put in, depending on the route.
For a cosmetic brief:
- The product type (toner, serum, cream, cleanser, shampoo and so on).
- The claims you want, written as sentences, each checked against the 56-item range.
- The texture, feel and fragrance direction.
- The destination markets, so the formula check can consider them.
- The container type and whether you supply packaging.
- Whether the product will also be sold in Japan, or is export-only.
For a quasi-drug brief, add:
- The effect category you are aiming for (for example whitening in the quasi-drug sense, or acne prevention as an active effect).
- Your willingness to accept the approval step and its uncertainty.
- Who will act as the responsible company in Japan if the product will be sold there.
If you are undecided, say so, and write two versions of the claim list: one inside the cosmetic range and one outside it. The factory can then tell you what each version means for the work. Which to choose is a commercial judgement for the brand.
Starting from a factory’s existing base formula versus a custom formula is a separate decision, covered in stock or custom formula. Once the category is fixed, the formula is checked against Japan’s ingredient rules, explained in checking a formula against the Standards for Cosmetics.
Mistakes that move a project from one category to the other late
Most late surprises come from wording added after the category was set — a product name, a marketing line or a translated claim that quietly crosses into quasi-drug territory.
The category is decided by the claim, and claims creep. These are the patterns to watch:
- A product name that carries a claim. If the name itself says “whitening” or “anti-acne”, the name is a claim. Check names with the same care as label text.
- Translation drift. A careful Japanese claim such as “prevents dryness of the skin” can become something stronger in another language. Keep a claims sheet with the Japanese-range wording and the translations side by side, and check each translation against the original meaning.
- Advertising that outruns the label. Website and social media copy is part of how a product is presented, so it must stay inside the same category as the label.
- Ingredient-led marketing. Attaching an effect to a called-out ingredient can turn into a claim. Use wording the cosmetic range allows, or leave the effect out.
- Assuming another market’s category carries over. Your destination may allow wording that Japan treats differently, and the reverse. Decide the Japanese category on Japanese terms, and the destination category with your importer.
The fix is the same in every case: freeze the claim list before samples, and treat any later wording change as a change request that is checked again.
💬 Want a second pair of eyes on your claim list and product name before you brief a factory? Send them to us, or see how our own-brand OEM service runs from brief to shipment.
Frequently asked questions
1. Can a cosmetic made in Japan say “whitening” on an export label?
In Japan, whitening wording in the sense of suppressing melanin production to prevent spots and freckles belongs to quasi-drugs, which need an approved active ingredient and a product approval. What an export label may say is governed by the destination market, but the product is still made under a Japanese category, so settle the claim before the brief rather than after.
2. Does a quasi-drug need approval if it is only for export?
The product-by-product marketing approval is the route for placing a quasi-drug on the Japanese market. The export-side procedures for quasi-drugs differ from the cosmetics export notification, so confirm them against the current text before you rely on any assumption.
3. Is the decision based on the ingredients or on the claim?
On the claim. The PMD Act defines categories by purpose. Two bottles with the same formula can fall into different categories because of what the label, the product name or the advertising says.
4. Can a cosmetic mention fine lines at all?
Yes, within limits. Item 56 of the efficacy range allows “makes fine lines caused by dryness less noticeable”, and the responsible company must confirm the effect through testing. Makeup effects from covering may also be described if they are true. Wrinkle improvement as such exists in Japan only for approved quasi-drugs.
5. What should the first line of my brief say?
State whether you are briefing a cosmetic or a quasi-drug, and list the claims you want in sentence form. If you have not decided, send two claim lists — one inside the cosmetic range and one outside it — and ask what each means for the project.