Short answer: Japan's revised quasi-drug ingredient standards and test methods became mandatory on 1 October 2026, ending a transition that began in March 2025. Dossiers built on the old specifications now need rework before filing.
Japan is one of the few markets where the regulatory category is decided by what you want to say rather than by what you have made. A brightening serum, an anti-acne lotion and a sunscreen are all quasi-drugs; the same base with softer claims is a cosmetic. That split has always shaped launch planning, and a standards revision that finished its transition on 1 October 2026 has just made the technical half of the file more demanding.
What changed, and when
In March 2025 the Ministry of Health, Labour and Welfare amended the Japanese Standards of Quasi-drug Ingredients, the technical standard that sets specifications and test methods for the ingredients used in quasi-drugs. The amendment revised specifications for a large set of listed ingredients — 222 of them — and updated 15 general test methods.
The revision took effect on publication, with a transitional period running to 30 September 2026. From 1 October 2026, affected products have to meet the revised standards and use the revised test methods. Companies that wanted to keep working to the previous specifications beyond that date had to file a minor change notice before the end of September 2026, citing the notification that introduced the amendment.
The cutover matters for two reasons that are easy to underestimate from outside the market. First, an ingredient that was acceptable under the old specification may now need a different grade, a different supplier or a different certificate. Second, a test method change is not paperwork: it can change the number on a certificate of analysis for the same material, which then disagrees with a specification written two years ago.
Cosmetic or quasi-drug: the claim decides
The classification question comes before any technical work, and it is answered by the claims you intend to make and the ingredients that support them.
| Dimension | Cosmetic | Quasi-drug |
|---|---|---|
| Governing route | Notification-based, Standards for Cosmetics apply | Pre-market approval by MHLW, with PMDA scientific review |
| What triggers it | Appearance and mild maintenance claims | Whitening, anti-acne, hair-growth, deodorant, sunscreen and similar efficacy claims |
| Ingredient framework | Standards for Cosmetics positive and negative lists | Japanese Standards of Quasi-drug Ingredients, including the revised specifications |
| Who holds the permission | A Japanese marketing authorisation holder for import and sale | The marketing authorisation holder, on an approved product |
| Manufacturing site | Must meet Japanese GMP expectations | Foreign site needs accreditation as a foreign manufacturer |
| Label | Japanese mandatory particulars | Japanese particulars plus the approval number and approved efficacy wording |
| Typical time to first sale | Weeks to a few months | Several months to well over a year, driven by approval and site accreditation |
The table is deliberately blunt about the last row. Most of the elapsed time in a quasi-drug launch is not formulation; it is authorisation. A brand that starts the technical file three months before a retail date has usually started too late, and no amount of manufacturing speed closes that gap — mass production itself takes 10–15 days, which is a rounding error against an approval timeline.
What the cutover changes inside the dossier
A quasi-drug dossier is built from ingredient specifications, test methods, stability data and a manufacturing description. The revision touches the first two directly.
Specifications move. For the 222 revised ingredients, the acceptable specification may now include different assay limits, different impurity limits or a different identification approach. A supplier certificate issued against the old monograph is not wrong, but it no longer matches the standard the reviewer will apply. Every raw material in the formula has to be re-checked against the revised text, and the check has to reach the supplier's specification, not just the ingredient name.
Test methods move. The 15 revised general test methods can change a result without changing the material. A viscosity or assay value that sat comfortably inside a specification under the old method may sit near a limit under the new one. The practical response is to re-test at least the critical materials with the revised method before the dossier is compiled, so the numbers in the file are generated the same way the reviewer will generate them.
The formula may need a substitution. If a revised specification makes a current grade non-compliant, the fix is a new grade or a new supplier, and that triggers stability and compatibility work. This is the point where a Japan launch timeline moves by months rather than weeks, and it is better discovered at the ingredient list stage than after the stability study.
The authorisation chain, and who holds what
Four roles appear in almost every Japan launch, and confusing them is the second most common planning error.
The marketing authorisation holder is a Japanese entity that holds the approval and is accountable for the product in the market. It is not the overseas brand and not the factory.
The foreign manufacturer accreditation applies to the overseas site that makes the product. A site that is not accredited cannot manufacture a quasi-drug for Japan, regardless of how good its GMP certificate is.
The approval attaches to the product, its formula, its claims and its manufacturing method. Changing the formula after approval is a variation, not a notification.
The importer moves the goods and holds the commercial relationship, but does not substitute for the authorisation holder.
For a brand building a Japan line from scratch, the sequence is therefore: decide category, secure the authorisation holder, confirm the manufacturing site's accreditation position, then compile the product dossier. Reversing the order wastes the most expensive part of the work.
What the factory supplies, and what it cannot
A Chinese contract manufacturer can supply the technical substance of the file: the full formula with percentages, ingredient specifications, a certificate of analysis per batch, stability data, a microbiological report, the process description and the GMP evidence behind the site. For our own site that means cosmetics production licence 粤妆20250206, GMPC and ISO 22716:2007 audited by third parties, and the standard four-document pack with each order.
What it cannot supply is a Japanese approval, a marketing authorisation holder, or a claim that its site is accredited as a foreign manufacturer unless that accreditation exists. Those belong to the Japanese side of the chain, and any supplier that blurs the line is telling you something useful about how it handles regulatory language.
The same discipline applies to test data. SPF and efficacy testing for a Japanese quasi-drug filing follows the route the reviewer expects, and evidence generated for another market is supporting material rather than a substitute — a point that also applies in Korea's substantiation rules, where in-vitro data has become more central but not universally accepted.
Where launches stall
Three stalls account for most delays, and all three are visible early if someone looks.
The claim set is translated rather than rebuilt. Efficacy wording approved in another market rarely maps onto the Japanese approved wording. A claim that reads as mild in English can imply a quasi-drug efficacy in Japanese, pushing the product into a category the file was not built for.
The ingredient review happens after the formula is frozen. The 222 revised specifications make this more expensive than it used to be. Review the ingredient list against the current standard before the first pilot batch, not after the stability study.
The site accreditation is assumed. A GMP certificate is evidence of a quality system; it is not an accreditation to manufacture quasi-drugs for Japan. Confirm the site's position before quoting a launch date.
The most repeated wrong statement
"Japan is easy — it is a notification market like the EU."
For ordinary cosmetics, the notification comparison is fair. For anything with a quasi-drug claim, it is wrong by roughly a year of lead time and an entire authorisation layer. The confusion usually originates in a product that started as a cosmetic and acquired a brightening or SPF claim late in development, at which point the category changed and the plan did not.
The second version of the same error is assuming the standards revision was a formality. A transition period that ends on a fixed date is a deadline, and a dossier compiled against superseded specifications is a dossier that has to be rebuilt.
FAQ
Q: What changed for Japanese quasi-drugs on 1 October 2026? A: The transitional period for the March 2025 amendment to the Japanese Standards of Quasi-drug Ingredients ended on 30 September 2026. From 1 October 2026, affected products must meet the revised specifications for 222 ingredients and use the 15 revised general test methods.
Q: How do I know whether my product is a cosmetic or a quasi-drug in Japan? A: The intended claims decide it. Whitening, anti-acne, hair-growth, deodorant and sunscreen claims place a product in the quasi-drug category, which requires pre-market approval; appearance and mild maintenance claims keep it a cosmetic under the notification route.
Q: Can a Chinese factory hold the Japanese approval? A: No. The approval is held by a Japanese marketing authorisation holder, and the overseas manufacturing site needs foreign manufacturer accreditation. The factory supplies the formula, specifications, batch data and GMP evidence that support the filing, but not the authorisation itself.
Q: Does the standards revision affect existing approved products? A: Yes. Approved products containing revised ingredients had to move to the updated standards from 1 October 2026, unless a minor change notice was filed before the end of September 2026 to continue under the previous specifications.