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).