Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
May 15, 2025
Approximately 5 minutes
Standards for Marketing Approval of Athlete’s Foot and Ringworm Remedies in Japan
Standards for Marketing Approval of Athlete’s Foot and Ringworm Remedies (Japan)
The Standards for Marketing Approval of Athlete’s Foot and Ringworm Remedies were issued by the Pharmaceuticals and Medical Devices Agency of Japan under Notification PSB No.447 on May 15, 1998. These standards define the regulatory criteria for external medicines intended to relieve symptoms associated with athlete’s foot and ringworm. Preparations deviating from these standards are reviewed based on submitted efficacy and safety data, and reasons justifying ingredient combinations. (PMDA, 000272501.pdf).
Scope
These standards cover external anti-fungal medicines for treatment of athlete’s foot, jock itch and ringworm. Traditional Kampo formulas and crude drug remedies consisting only of crude drug are excluded. (PMDA, 000272501.pdf).
Active Ingredients
- Permissible active ingredients and their allowable combinations are listed in Table 1 of the standards.
- At least one active ingredient from Column I (excluding Groups 12 & 13) or Column II must be included.
- Ingredients in different columns may be combined, with limits on the number and grouping of ingredients from some columns (e.g., only one ingredient from Column V may be used when combined with others in the same column).
- Certain active ingredients are prohibited from being combined (e.g., combinations within Column VI or certain pairs in Column VII). (PMDA, 000272501.pdf).
Quantities of Active Ingredients
- Maximum concentration of each active ingredient is defined in Table 1.
- For Column I (except Groups 12 & 13) and Column II, the minimum concentration is 1/5th of the maximum; at least one ingredient must be present at at least half of the specified maximum concentration.
- For Group 12, Group 13 and Columns III–IX, the minimum concentration is 1/10th of the maximum, except where a specific value is provided (e.g., benzalkonium chloride). (PMDA, 000272501.pdf).
Dosage Form
Approved dosage forms include aerosols, ointments, external liquids and external powders intended for application to affected skin areas. (PMDA, 000272501.pdf).
Dosage and Administration
Treatments should be applied to the affected skin surface several times a day, and the method of application should be clearly indicated on labelling and instructions. (PMDA, 000272501.pdf).
Indications
Indications for approved products must fall within the scope of “athlete’s foot, jock itch and ringworm” and associated symptoms. (PMDA, 000272501.pdf).
Summary
These standards provide the regulatory framework for marketing approval of athlete’s foot and ringworm remedies in Japan, detailing acceptable ingredients, concentration limits, dosage forms, application methods, and associated indications to ensure safety and efficacy. (PMDA, 000272501.pdf).
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