Standards for Marketing Approval of Antivertigo Medicines in Japan

Standards for Marketing Approval of Antivertigo Medicines (Japan)

The Standards for Marketing Approval of Antivertigo Medicines were issued by the Pharmaceuticals and Medical Devices Agency of Japan as Notification PB No.381 on June 1, 1984. These standards specify regulatory criteria for oral medications intended to prevent or relieve symptoms associated with motion sickness, including dizziness, nausea, and headache. Preparations that do not conform to these criteria require submission of efficacy and safety data for review. (PMDA, 000272494.pdf).

Scope

The standards apply to oral antivertigo medicines for relief or prevention of motion sickness symptoms. Traditional Kampo medicine formulas are excluded. (PMDA, 000272494.pdf).

Active Ingredients

The types of permissible active ingredients and combination rules are outlined in Table 1. At least one ingredient from Column I or Group 1 of Column II must be included. Ingredients from different columns and groups may be combined following specified limits, and vitamins may be added where justified. (PMDA, 000272494.pdf).

Quantities of Active Ingredients

For each listed active ingredient, maximum single and daily doses are specified in Table 1. Minimum dose limits and combination dose limits are defined depending on the grouping of the ingredients; for example, when two Column I ingredients are combined, the sum of fractional doses must be between 0.5 and 1 of the maximum single dose. (PMDA, 000272494.pdf).

Dosage Forms

Approved dosage forms include capsules, granules, pills, fine granules, powders, tablets (including chewable tablets) and oral liquids. (PMDA, 000272494.pdf).

Dosage and Administration

• Dosage is by oral administration 1–3 times per day (except preparations with dimenhydrinate, which may be dosed 1–4 times per day).
• Administration times and intervals (at least 4 hours apart for more than one dose per day) must be clearly indicated.
• Children under 3 years are generally not approved for use; certain active ingredients have higher age limits (e.g., ethyl aminobenzoate is not approved under 6 years, promethazine compounds are not approved under 15 years).
• For pills and tablets larger than 6 mm, dosage is not approved for children under 5 years.
• Age‑based dose adjustment coefficients are provided in Table 2. (PMDA, 000272494.pdf).

Indications

Approved indications are prevention and relief of dizziness, nausea, and headache associated with motion sickness. (PMDA, 000272494.pdf).

Packaging Units

For oral liquid formulations, container volume should generally be the amount for a single dose and not exceed 30 mL. (PMDA, 000272494.pdf).

Summary

These standards define the regulatory framework for marketing approval of antivertigo medicines in Japan, ensuring safety and efficacy through criteria on active ingredients, dose limits, dosage forms, administration, indications, and packaging. (PMDA, 000272494.pdf).