Standards for Marketing Approval of Antitussives and Expectorants in Japan

Standards for Marketing Approval of Antitussives and Expectorants (Japan)

The Standards for Marketing Approval of Antitussives and Expectorants were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.26 (with partial revision dated March 28, 2016). These standards set regulatory criteria for oral remedies intended to treat cough and sputum in Japan. Remedies not conforming to these standards require submission of supporting data for efficacy and safety. (PMDA, 000272490.pdf).

Scope

These standards apply to oral antitussives and expectorants, including tablets, capsules, pills, granules, powders, troches, drops, oral solutions and syrups. Remedies based on Kampo formulas or crude drugs alone are excluded. (PMDA, 000272490.pdf).

Active Ingredients

The standards include a Table 1 listing permitted active ingredients and their maximum single and daily doses. Combinations of active ingredients are allowed within defined limits, but some combinations are restricted or require justification. (PMDA, 000272490.pdf).

Quantities of Active Ingredients

Requirements specify:

• Maximum single and daily doses for each ingredient.
• Limits on combined doses when multiple ingredients are used.
• Lower limits for active ingredient amounts in combinations.
• Special provisions for ingredients in troches and drops. (PMDA, 000272490.pdf).

Dosage Forms

Approved dosage forms include tablets, capsules, pills, granules, powders, troches, drops, oral solutions and syrups; elixirs are excluded. (PMDA, 000272490.pdf).

Dosage and Administration

The general regimen is 3 to 4 times per day, with up to 5–6 doses per day for troches, drops, oral solutions and syrups under specified conditions. Age‑based restrictions apply: some formulations are not approved for young children or infants, and doses for children under 15 are adjusted by age coefficients. (PMDA, 000272490.pdf).

Indications

Indications include cough, cough associated with wheezing, and sputum. Additional symptom claims (e.g., sore throat or throat discomfort) may be allowed for troches and drops meeting specified ingredient criteria. Correspondence between active ingredients and allowable indications is defined in the standards. (PMDA, 000272490.pdf).

Packaging Units

The maximum container volume for oral solutions and syrups must provide no more than a four‑day supply at the adult maximum daily dose. (PMDA, 000272490.pdf).

Summary

These standards form the regulatory framework for antitussive and expectorant OTC drugs in Japan. Conformance with ingredient lists, dose limits, dosage forms, administration regimens, indications and packaging rules is essential for marketing approval. (PMDA, 000272490.pdf).