Regulatory Framework
Japan regulates cosmetics under the PMD Act, with practical oversight involving MHLW, PMDA, and local prefectural authorities. The market draws a sharp line between ordinary cosmetics and quasi-drugs. Products positioned with approved functional or medicinal-style effects may fall into the quasi-drug route and require a much more demanding review path.
Cosmetic Definition
Substances used on the human body to cleanse, beautify, promote attractiveness, alter appearance, or keep skin and hair in good condition, provided their action on the body is mild and they are not classified as drugs or quasi-drugs.
Responsible Person Requirements
An overseas brand cannot place cosmetics on the Japan market directly. A Japan-established Marketing Authorization Holder must act as the primary responsible entity, control import and release activities, and maintain the local quality and vigilance structure required under the Japan framework.
Compliance Process
- MAH Qualification and Scope Confirmation
- Appoint a Japan-based MAH and confirm whether the product is an ordinary cosmetic or falls into the quasi-drug pathway.
- Align responsibility for import notification, local testing, label release, and post-market quality and vigilance.
- Formula and Japanese Label Review
- Screen the formula against Japan cosmetics standards and category-specific restrictions.
- Review the Japanese artwork to ensure compliant ingredient naming, MAH details, batch information, and claim discipline.
- Import Notification and Release Controls
- Prepare the import notification package used before the first customs release in Japan.
- Coordinate the initial local quality checks and release controls after customs clearance.
- Quasi-drug Escalation if Applicable
- For products with quasi-drug positioning, prepare the stronger safety, efficacy, and dossier package needed for the longer approval route.
- Track authority review questions through to the final decision before launch.
Many claims that are treated as standard cosmetics elsewhere can move a product into the quasi-drug route in Japan, so claim screening is a key early decision point.
Deliverables
- Japan route classification between ordinary cosmetics and quasi-drugs
- MAH onboarding and local compliance coordination
- Formula screening against Japan cosmetics standards
- Japanese artwork and claim review
- Import notification and release-control checklist
- Quasi-drug dossier planning where applicable
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