규제 현황
The regulatory framework for cosmetics (broadly defined as beauty products) in Japan is governed by the Pharmaceuticals and Medical Devices Act (PMDL). This framework is overseen by the Ministry of Health, Labour and Welfare (MHLW) and jointly executed by the Pharmaceuticals and Medical Devices Agency (PMDA) and local prefectural governments.
The core of this regulatory system lies in the differentiated management of products, which are categorized into two main classes:
Cosmetics: Products intended to be applied to the human body by rubbing, sprinkling, or other methods for cleansing, beautifying, promoting attractiveness, altering the appearance, or keeping the skin or hair in healthy condition, provided that their action on the human body is mild. These products do not require pre-market approval but are subject to a notification process prior to marketing.
Quasi-drugs (Medicated Products / Iyakubuhaihin): Products that have a specific efficacy, exert a mild action on the human body, and fall squarely between pharmaceuticals and cosmetics. They must contain active ingredients approved by the MHLW and can claim specific benefits. These products are subject to a strict pre-market approval process, which includes a comprehensive assessment of product safety, efficacy, and quality.
알림/등록 절차
Main Compliance Process for Cosmetics
Main Compliance Process for Quasi-Drugs (Pseudo-pharmaceuticals)
Required Documentation
Cosmetics Notification
- Manufacturer Notification (Filing): Application form, proof of manufacturing qualifications, basic company information, etc.
- Marketing License: The primary marketing license (Seizo-hanbai-gyo) held by the local Japanese representative.
- Manufacturer Information: Details regarding the manufacturing facility.
- Product Information: Including but not limited to product name, ingredient names, purpose of use and concentrations, Japanese-compliant label text, and packaging artwork/diagrams.
Quasi-Drug Registration
- Manufacturer Registration: Including but not limited to the application form, an overview of the manufacturing facility's equipment and structure, factory blueprints, building layouts, and official documents proving manufacturing and business qualifications.
- Marketing License: The primary marketing license (Seizo-hanbai-gyo) held by the local Japanese representative.
- Origin and Development History: Documentation on the country of origin, the product development process, and its history of use overseas.
- Physicochemical Properties, Specifications, and Testing Methods: Detailed data regarding the physical and chemical properties, product specifications, and analytical testing methods for both the finished product and its active ingredients.
- Stability Data: Documentation demonstrating the product's stability under various conditions over time.
- Safety Data: Comprehensive toxicological and safety evaluation data.
- Efficacy Validation Data: Scientific data and clinical/laboratory evidence supporting the claimed benefits and efficacy.
- Exemptions for Items 3 to 7: Depending on the risk classification and category of the quasi-drug, requirements for items 3 through 7 may be reduced or exempted.
선택해야 하는 이유
전문가의 안내와 유연한 규정 준수 솔루션으로 장벽이 높은 일본 시장을 공략하세요.
포괄적인 솔루션
화장품이 규정을 완벽하게 준수하고 일본 시장에 진출할 수 있도록 지원하는 규제 솔루션입니다.
자주 묻는 질문
일본 시장에 진출하기 전에 가장 먼저 해야 할 일은 무엇인가요?
규제 경로가 크게 다르므로 제품이 화장품인지 의약외품인지 확인합니다.
일본에서는 누가 책임 주체가 될 수 있나요?
일본 후생노동성(MHLW)의 감독 하에 허가된 마케팅 허가 보유자를 설립해야 합니다.
일본에서 화장품은 신고가 필요한가요?
예. 판매 전에 제조업체 신고(PMDA를 통해)와 제품 신고(현지 당국에)를 모두 완료해야 합니다.
의약외품은 승인이 필요한가요?
예. 의약외품은 시판 전 승인을 받아야 하며, 여기에는 GMP 검사 및 기술 검토가 포함될 수 있습니다.
일반적인 규정 준수 위험은 무엇인가요?
주요 위험에는 잘못된 분류, 규정을 준수하지 않는 성분, 지원되지 않는 클레임, 라이선스 또는 GMP 준수 누락 등이 있습니다.