規制の背景
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.
通知／登録プロセス
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.
選ばれる理由
専門家のガイダンスと柔軟なコンプライアンス・ソリューションで、障壁の高い日本市場をナビゲートします。.
包括的なソリューション
貴社の化粧品が日本市場に適合し、準備万端であることを保証する規制ソリューション。.
よくある質問
日本市場に参入する前の最初のステップは何ですか？
規制経路が大きく異なるため、製品が化粧品か医薬部外品かを判断する。.
日本では誰が責任主体として行動できるのか？
厚生労働省（MHLW）の監督のもと、認可を受けた製造販売業者が設立されなければならない。.
日本では化粧品に届出が必要ですか？
はい。販売前に、製造業者への届出（PMDA経由）と製品への届出（地方自治体への）の両方が完了している必要があります。.
医薬部外品に承認は必要か？
はい。医薬部外品は製造販売承認を取得する必要があり、これにはGMP査察や技術審査が含まれる。.
一般的なコンプライアンス・リスクとは？
主なリスクには、誤った分類、非適合成分、裏付けのない主張、ライセンスやGMPコンプライアンスの欠如などがある。.