Quasi drug meaning in Japan and product approval explained
A quasi-drug is a distinct Japanese legal category with mild effects. Learn how classification, product approval and ingredient standards differ.
In Japan, a quasi-drug (医薬部外品) is a legally defined product category with mild effects on the human body. It is distinct from cosmetics and generally requires product-specific marketing approval, subject to exceptions under the PMD Act.
For a formulation or regulatory team, the distinction affects the product's approval route and the ingredient standards to check. An ingredient entry alone does not authorise a finished product or its claims. Compare the product approval provisions with the separate ingredient standards.
What counts as a quasi-drug in Japan?
Article 2(2) covers specified purposes and products designated by the Minister of Health, Labour and Welfare. The statutory purposes include preventing body odour, preventing hair loss, promoting hair growth and removing hair. Another group covers control of organisms such as mosquitoes and fleas for human or animal health. These groups have statutory limits, including exclusions for products also intended for specified pharmaceutical purposes. Read the Japanese legal definition.
The category extends beyond skincare. The Ministry of Health, Labour and Welfare (MHLW) lists category-specific approval standards or review guidance. Examples include hair colouring agents, medicated toothpastes, bath additives and sanitary napkins. That does not make every toothpaste or bath product a quasi-drug. Check the product against the relevant category standards and guidance.
An official English translation uses “quasi-pharmaceutical products.” That version reflects a 2015 amendment, so use it for terminology rather than as the operative Japanese text. The translation is a reading aid. The Japanese law controls.
Quasi-drugs versus cosmetics
“Mild” does not settle classification. Article 2(3) also describes cosmetics as having mild action. Their purposes include cleaning, beautifying, changing appearance or maintaining healthy skin or hair. The definition expressly excludes quasi-drugs. Calling an ingredient "active" does not settle the classification. Intended use and statutory designation matter. Both definitions appear in Article 2.
The approval distinction also needs care. Under Article 14(1), quasi-drugs generally require approval for each product. Exceptions exist for minister-designated products with established standards. The same provision requires approval for cosmetics containing certain minister-designated ingredients. Neither “all quasi-drugs need approval” nor “cosmetics never need approval” is a safe rule. Check Article 14 for the approval scope.
Cosmetics outside that approval scope follow the advance product-notification route in Article 14-9. Notification is not approval. It also does not remove the need to check business-licensing obligations. Confirm the applicable route before treating a Japanese launch as a notification-only product filing.
What the Japanese ingredient standards do
The Japanese Standards of Quasi-drug Ingredients 2021, 医薬部外品原料規格2021, are commonly called 外原規. The original notice is dated 25 March 2021. These are ingredient standards, distinct from ordinary cosmetics standards and from finished-product approvals. PMDA lists the standards and related notices.
The 2021 standards were partially amended in March 2025. The edition title alone therefore cannot tell you which text applies to an ingredient. MHLW provides an incorporated reference version but directs readers to the partial-amendment notifications for detailed changes. Consult the ingredient entry and applicable amendment notices, together with the relevant category guidance.
Do not treat a listed ingredient as permission for a formulation, concentration or claim. Article 14 separately addresses product quality, efficacy and safety, including ingredients, quantities, directions and claimed effects. Ingredient-specification compliance does not replace that finished-product assessment.
RegAffairs AI's answer on quasi-drugs in Japan covers the legal definition and ingredient standards. For a market-entry decision, confirm classification first, then the product route and applicable ingredient requirements against the official law and guidance.