February 20, 2026

Japan’s quasi-drug (Iyaku-Bugaibuhin) category is one of the most technically regulated product classifications in the global personal care and functional cosmetics market. Positioned between cosmetics and pharmaceuticals, quasi-drugs allow limited pharmacological claims while demanding pre-market regulatory approval.

For global brands entering Japan, understanding the MHLW–PMDA regulatory pathway, ingredient control system, MAH requirements, and labeling restrictions is essential to avoid costly delays.

Maven Regulatory Solutions supports international companies with Japan quasi-drug registration strategy, MAH coordination, technical dossier preparation, and post-market compliance.

What Are Japanese Quasi-Drugs?

Quasi-drugs are products with mild active ingredients intended for:

  • Disease prevention
  • Symptom relief
  • Functional body care

They can claim specific effects not permitted for cosmetics.

Typical Quasi-Drug Categories

Product TypePermitted Functional Claims
SunscreensUV protection with efficacy labeling
Whitening essencesMelanin suppression / brightening
Anti-hair loss shampooHair growth support
Acne treatment tonerAcne prevention
AntiperspirantsOdor & sweat control
Medicated hand sanitizersAntibacterial function

Regulatory Authorities

AuthorityRole
MHLWRegulatory policy & standards
PMDAScientific and technical review
Prefectural GovernmentsLicensing, inspections, enforcement

Quasi-Drug Classification Pathways

CategoryRegistration Complexity
General Quasi-DrugsStandardized actives & claims
New Quasi-DrugsNovel ingredients or new efficacy claims (longer review)

General Import Registration Process

Step 1 Ingredient & Efficacy Verification

  • Active ingredients must be listed by MHLW
  • Concentrations within approved ranges
  • Claims limited to approved efficacy scope

Step 2 Appoint a Marketing Authorization Holder (MAH)

All imported quasi-drugs require a Japan-based MAH responsible for:

  • Registration submission
  • Product quality oversight
  • Recalls & pharmacovigilance
  • Market compliance

Step 3 Dossier Preparation

Key documents include:

  • Application forms (MHLW format)
  • Product specification file
  • Stability & microbiological data
  • Safety support documentation
  • GMP evidence from manufacturing site

Step 4 Submission & Review

Submitted via MAH to PMDA/local authority.
Review may request supplemental safety or composition data.

Typical timeline: 4–12 months.

Step 5 Approval Number Issuance

A unique quasi-drug approval number must appear on labels.

Labeling & Packaging Compliance

Mandatory Japanese labeling includes:

  • Product name + quasi-drug classification
  • Approval number
  • Active ingredients
  • Usage instructions
  • Precautions
  • MAH contact details
  • Lot, expiry, origin

Prohibited claims: “cure,” “guaranteed,” “medical effect.”

Customs & Import Requirements

  • Approval documentation
  • Certificate of origin
  • Ingredient list
  • Commercial invoice
  • Non-compliance may lead to import rejection.

Post-Market Compliance Obligations

RequirementPurpose
Adverse event reportingSafety monitoring
Recall systemConsumer protection
Regulatory inspectionsMarket surveillance
Advertising controlPreventing misleading claims

2026 Regulatory Trends in Japan

  • Increased scrutiny on functional whitening & sunscreen actives
  • Strengthening of GMP documentation review
  • Digital tracking of MAH responsibilities
  • Focus on evidence-based efficacy claims

How Maven Regulatory Solutions Supports

  • Quasi-drug ingredient review
  • MAH coordination
  • Registration dossier compilation
  • Label & claims compliance
  • PMDA query response support
  • Post-market vigilance setup

FAQ

Is sunscreen a cosmetic in Japan?
No most sunscreens are regulated as quasi-drugs.

Can foreign companies register directly?
No. A local MAH is mandatory.

Are claims flexible?
No. Only MHLW-approved claims are allowed.