Browse Quasi-Drug Products cosmetics OEM manufacturers in Japan. Find contract manufacturing partners. Filter by small lot options and sample availability. Free consultations available.
製造許可
医薬部外品製造業許可の取得は必須。製造販売業許可も併せて持っていると承認手続きがスムーズです
承認取得サポート
新規処方の医薬部外品承認取得をサポートしてくれるかどうかは、初めてのOEMでは特に重要です
有効成分
美白・育毛・制汗・殺菌など、目的に合った有効成分の取り扱い実績と処方開発力を確認しましょう
品質認証
GMP認証の取得、安定性試験・安全性試験の自社対応が可能かを確認しましょう
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Key regulations and requirements for importing Quasi-Drug Products from Japan
Japan's 'quasi-drug' (医薬部外品) category does not exist in US law. Products may be classified as either OTC drugs or cosmetics depending on their claims and active ingredients. Medicated shampoos, sunscreens, and anti-acne products typically fall under OTC drug regulation.
Determine whether the product will be marketed as an OTC drug or cosmetic in the US. Prepare appropriate documentation including product formulation, efficacy data, and safety data.
Ministry of Health, Labour and Welfare (MHLW)
If classified as an OTC drug, the product must comply with applicable FDA OTC monograph (e.g., sunscreen monograph, acne monograph). Active ingredients must be listed in the monograph at specified concentrations.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Food and Drug Administration (FDA)
OTC drug manufacturers must register with FDA as a drug establishment and list all products. This is separate from the cosmetics registration under MoCRA.
Food and Drug Administration (FDA)
OTC drugs require a 'Drug Facts' panel listing active ingredients, uses, warnings, directions, and inactive ingredients in a specific format.
Food and Drug Administration (FDA)
Japanese quasi-drugs that make medicinal claims (whitening, hair growth, anti-dandruff) will likely be classified as OTC drugs in the US, requiring monograph compliance or an NDA. Reformulation may be necessary if the active ingredients are not in FDA OTC monographs.
6-18 months (classification determination, monograph compliance, possible reformulation, FDA registration)
Japan's quasi-drugs with cosmetic functions (whitening, sunscreen, anti-hair loss) are classified as 'special cosmetics' (特殊化妆品) in China, requiring full NMPA registration — a significantly longer and more expensive process than general cosmetics filing.
CFS plus detailed product documentation including full formula, manufacturing process, and efficacy/safety data required for NMPA registration.
Ministry of Health, Labour and Welfare (MHLW)
Special cosmetics (whitening, sunscreen, hair dye, hair perm, anti-hair loss, breast care, body odor) require NMPA registration. This includes technical review, human safety and efficacy testing, and expert panel review.
National Medical Products Administration (NMPA)
Special cosmetics require more extensive testing than general cosmetics, including SPF/PA testing for sunscreens, human patch tests, and efficacy evaluation.
National Medical Products Administration (NMPA)
NMPA special cosmetics registration typically takes 12-24 months. The process includes: sample preparation and submission, lab testing (3-6 months), technical review (3-6 months), and administrative review. Budget $30,000-$80,000+ per product.
Some Japanese quasi-drugs can be reformulated or repositioned as 'general cosmetics' in China by removing medicinal claims or active ingredients. This avoids the lengthy special cosmetics registration. Consult with a Chinese regulatory specialist.
12-24 months for special cosmetics registration
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.