Standards for Marketing Approval of Laxatives in Japan

Standards for Marketing Approval of Laxatives (Japan)

The Standards for Marketing Approval of Laxatives were issued under Notification PB No.463 on May 17, 1982 and finally revised on May 15, 1998. These standards define criteria for marketing approval of oral medicines intended to relieve symptoms of constipation or assist the elimination of intestinal contents in Japan, excluding preparations covered by gastrointestinal medicine standards and Kampo herbal formulas. (PMDA, 000272493.pdf).

Scope

These standards apply to oral laxative medicines for relief of constipation and related bowel evacuation, but exclude products covered by other standards such as gastrointestinal medicines and Kampo formulas. (PMDA, 000272493.pdf).

Active Ingredients

Permitted active ingredients are listed in Table 1 (Column A and Column B) and Table 2. Requirements include:

• At least one active ingredient from Table 1 must be included.
• Specific rules limit combinations across groups and columns.
• Certain combinations among Group IV ingredients are prohibited. (PMDA, 000272493.pdf).

Dosage Amounts

The standards specify:

• Maximum single and daily doses for all active ingredients.
• Limits on combined doses when more than one ingredient is used.
• Minimum doses for live bacteria used for intestinal regulation. (PMDA, 000272493.pdf).

Dosage Forms

Approved forms include capsules, granules, pills, fine granules, powders, lingual tablets (for certain ingredients), tablets, infusions, decoctions, chocolate preparations, syrups, and oral liquids where appropriate. (PMDA, 000272493.pdf).

Dosage and Administration

• Medicines are generally taken 1–3 times daily, with at least 4 hours between doses.
• Preparations with certain main ingredients are taken once daily as needed.
• Dosing guidance must include ranges for degrees of constipation.
• Children under three years old are generally not approved; specific dosing rules apply for infants and small children based on age. (PMDA, 000272493.pdf).

Indications

• Column I active ingredients are indicated primarily for constipation and associated symptoms such as dull headache, loss of appetite, abdominal fullness, abnormal intestinal fermentation and hemorrhoids.
• Column II ingredients are indicated for rapid excretion of intestinal contents (e.g., in food poisoning). (PMDA, 000272493.pdf).

Packaging Units

For syrup preparations, the maximum container volume is limited to a two‑day supply at the adult maximum daily dose. (PMDA, 000272493.pdf).

Summary

These standards provide the regulatory framework for OTC laxatives in Japan. Compliance with active ingredient lists, dose limits, dosage forms, administration guidance, indications, and packaging rules is essential for marketing approval. (PMDA, 000272493.pdf).