Standards for Marketing Approval of Anthelmintics in Japan

Standards for Marketing Approval of Anthelmintics (Japan)

The Standards for Marketing Approval of Anthelmintics were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.300 on March 28, 1989 with a final revision on May 15, 1998. These standards provide regulatory criteria for oral medicines intended to eradicate parasitic infections. Preparations not conforming to the criteria require submission of efficacy and safety data and justification for ingredient combinations. (PMDA, 000272498.pdf).

Scope

Anthelmintics under these standards include oral preparations designed to eradicate parasites. Traditional Kampo (herbal) medicine formulations are not covered by this standard. (PMDA, 000272498.pdf).

Active Ingredients

Permissible active ingredients and their combinations are defined in Table 1. Key points include:

• At least one active ingredient from Column A must be included.
• Preparations with ingredients from groups within Column A can include selected ingredients from Columns B, C or D according to grouping rules.
• Only one active ingredient from certain columns or groups may be used in a single preparation. (PMDA, 000272498.pdf).

Quantities of Active Ingredients

• The maximum daily dose for each active ingredient is specified in Table 1.
• Lower daily dose limits depend on combinations of specific active ingredients from Columns A, B, C, or D.
• When multiple Column A ingredients are combined, the fractional sum of each based on their maximum dose must satisfy defined thresholds. (PMDA, 000272498.pdf).

Dosage Forms

Approved dosage forms for anthelmintics include capsules, granules, pills, powders, tablets, decoctions (for certain active ingredients), chocolate tablets, and oral liquids. (PMDA, 000272498.pdf).

Dosage and Administration

The standards specify dosing regimens based on the category of active ingredients:

• Preparations containing certain Column A ingredients may be taken once or twice a day on an empty stomach, or once before bed and once the next morning.
• Preparations with other Column A group ingredients have defined treatment durations (e.g., eradication of ascarids over 1–2 days, oxyurids over 1 week).
• Decoctions must include clear preparation instructions.
• Infants under 3 months are not approved; children under 5 years are restricted for larger dosage forms.
• Maximum daily doses for individuals under 15 years are adjusted by age coefficients in Table 2. (PMDA, 000272498.pdf).

Indications

• Preparations with specific Column A group ingredients are indicated for eradication of ascarids and oxyurids, or oxyurids alone.
• Other anthelmintic preparations may be indicated for eradication of ascarids. (PMDA, 000272498.pdf).

Summary

These standards establish the regulatory framework for marketing approval of anthelmintic medicines in Japan. Conformance with active ingredient requirements, dose limits, dosage forms, administration guidance, age restrictions, and indications is essential to obtain approval. (PMDA, 000272498.pdf).