Standards for Marketing Approval of Antipruritic and Anti-inflammatory Drugs in Japan

Standards for Marketing Approval of Antipruritic and Anti-inflammatory Drugs (Japan)

The Standards for Marketing Approval of Antipruritic and Anti-inflammatory Drugs were issued as Notification PFSB No.1101-1 on November 1, 2011. These standards specify regulatory criteria for external dermal medicines primarily containing adrenocortical hormones or antihistamines intended to relieve itching and inflammation of the skin. Preparations not conforming to these standards require submission of supporting efficacy and safety data and justification for combinations. (PMDA, 000272502.pdf).

Scope

The standards apply to medicines mainly containing adrenocortical hormones or antihistamines for dermal application formulated as antipruritic and anti-inflammatory drugs. (PMDA, 000272502.pdf).

Types of Active Ingredients

• Permissible active ingredients and grouping rules are defined in the table within the standards.
• At least one active ingredient from Column I or Column II must be present.
• Preparations mainly containing Column I ingredients may include ingredients from Columns II, III, IV, V, VI, VII, VIII, IX, X or XII.
• Preparations mainly containing Column II ingredients may include those from Columns III, IV, V, VI, VII, VIII, IX, X, XI or XII.
• Only one active ingredient per column I, II, IV, V, VII, VIII or IX is permitted; some groups in Columns X and XII also limit the number of ingredients. (PMDA, 000272502.pdf).

Quantities of Active Ingredients

• Maximum concentration for each active ingredient is specified in the table.
• The minimum concentration for many ingredients (Columns II, III, V, VI, VIII, certain groups in X and XII, Column XI) is 1/5 of the maximum; for ingredients mainly in Group 1 of Column I or Group 2 of Column II the minimum must be at least half the maximum.
• For ingredients listed in Columns IV, VII, IX and certain groups in Columns X and XII, the minimum concentration is 1/10 of the maximum. (PMDA, 000272502.pdf).

Dosage Forms

Approved forms include liquids for external use, sprays, ointments, creams and gels. Preparations with Column I active ingredients are excluded from the spray category. (PMDA, 000272502.pdf).

Dosage and Administration

The preparation should be applied to the skin surface several times a day, and the method of application must be clearly indicated on labeling and instructions. (PMDA, 000272502.pdf).

Indications

Indications depend on the main active ingredient groups:

• Group 1 of Column I: eczema, dermatitis, miliaria, irritated skin, itching, chilblains, insect bites, urticaria.
• Group 2 of Column I: eczema, dermatitis, miliaria, irritated skin, itching, insect bites, urticaria.
• Column II: eczema, dermatitis, skin sore, miliaria, irritated skin, itching, chilblains, insect bites, urticaria. (PMDA, 000272502.pdf).

Summary

These standards establish the regulatory framework for marketing approval of antipruritic and anti-inflammatory dermal medicines in Japan, including permitted active ingredients, concentration limits, dosage forms, application methods, and indications to ensure safety and efficacy. (PMDA, 000272502.pdf).