Standards for Marketing Approval of Gastrointestinal Medicines in Japan

Standards for Marketing Approval of Gastrointestinal Medicines (Japan)

The Standards for Marketing Approval of Gastrointestinal Medicines were issued as Notification PFSB No.520, with the final revision dated March 28, 1986. These standards specify regulatory criteria for oral medicines intended to relieve symptoms of gastrointestinal disease. Preparations not conforming to these standards must be supported by efficacy and safety data with justification. (PMDA, 000272492.pdf).

Scope

These standards cover all oral medicines formulated to relieve gastrointestinal symptoms. Preparations such as evacuants and Kampo medicines (traditional Japanese herbal formulas) are excluded from this scope. (PMDA, 000272492.pdf).

Active Ingredients

Permitted active ingredients and their classifications are listed in Table 1 of the standards, which are divided into multiple columns (I–VIII) with specific combination rules. Certain ingredients cannot be combined depending on their column groupings, ensuring safety and predictable effects. (PMDA, 000272492.pdf).

Quantities of Active Ingredients

The standards define the maximum daily doses for all listed active ingredients. The maximum single dose is generally one‑third of the maximum daily dose. When ingredients from the same group are combined, the sum of fractional doses must not exceed defined limits. Additional provisions cover acid–neutralizing capacity for antacid agents and minimum digestive activity for enzyme products. (PMDA, 000272492.pdf).

Dosage Forms

Approved dosage forms include capsules, granules, pills, fine granules, powders, electuaries, tablets, infusions, decoctions, or liquids for oral use (limited to preparations mainly containing selected ingredients with mild action). (PMDA, 000272492.pdf).

Dosage and Administration

In general, gastrointestinal medicines should be taken three times a day. Oral liquids or preparations containing certain ingredients may be dosed between 1 and 3 times a day, with at least 4 hours between doses. Infusion and decoction preparations must indicate preparation instructions. Use in infants under 3 months of age is not approved; restrictions apply by formulation size and age for children. (PMDA, 000272492.pdf).

Indications

Indications vary based on the main active ingredient column and are listed in Table 3. They include relief of hyperacidity, heartburn, nausea, indigestion, appetite loss, abdominal discomfort, diarrhea, constipation, spasms and related gastrointestinal symptoms. The use of certain ingredient combinations may limit allowable indications. (PMDA, 000272492.pdf).

Packaging Units

Age coefficients for children under 15 are provided in Table 2, specifying adjustments to maximum daily doses. These coefficients ensure dosing is scaled appropriately by age group. (PMDA, 000272492.pdf).

Summary

These standards form the regulatory framework for marketing approval of OTC gastrointestinal medicines in Japan. Conformance with active ingredient lists, dose limits, dosage forms, administration regimens, indications and age‑based dosing rules is essential to obtain approval. (PMDA, 000272492.pdf).