Standards for Marketing Approval of Cold Remedies in Japan

Standards for Marketing Approval of Cold Remedies in Japan

The Standards for Marketing Approval of Cold Remedies were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.28 on March 25, 2015. This provisional English translation is for reference; the Japanese original is authoritative. The standards specify criteria for the approval of over‑the‑counter (OTC) cold remedies in Japan. (PMDA, 000272504.pdf).

Overview

Cold remedies are regulated as OTC drugs and must conform to detailed criteria related to active ingredients, dosage forms, dosing and administration, indications and packaging to obtain marketing approval in Japan. (PMDA, 000272504.pdf).

Active Ingredients and Maximum Daily Doses

The standards include a comprehensive Table 1 listing active ingredients and their maximum daily doses across categories such as analgesics, antihistamines, cough suppressants and expectorants. For example, acetaminophen, ibuprofen and aspirin are assigned specific upper limits. When components are combined, total exposure is constrained by combination rules. (PMDA, 000272504.pdf).

Dosage Forms

Approved dosage forms include tablets, capsules, pills, granules, powders and syrups. Each form must meet the standards’ specifications. (PMDA, 000272504.pdf).

Dosage and Administration

Oral products, except syrups, are taken three times a day within 30 minutes after meals. Syrups are taken after meals and, when necessary, before going to bed or up to six times a day with at least four hours between doses. Age‑based restrictions apply, e.g., most oral forms are not approved for children under certain ages (e.g., under 3 or 5 years) depending on dosage form and ingredients. (PMDA, 000272504.pdf).

Indications

Cold remedies are indicated for symptomatic relief of common cold symptoms: runny nose, stuffy nose, sneezing, sore throat, cough, phlegm (sputum), chills, fever, headache, joint pain and muscle pain. Certain symptom claims depend on inclusion of relevant active ingredients listed in the standard’s tables. (PMDA, 000272504.pdf).

Packaging Units

For syrups, the maximum container volume is limited to a two‑day supply at the maximum daily dosage for children aged 6 years, ensuring appropriate pediatric supply and safety. (PMDA, 000272504.pdf).

Conclusion

These standards provide a clear regulatory framework for developers and manufacturers of OTC cold remedies in Japan. Conformance with the active ingredient limits, dosage forms, administration requirements, indication definitions and packaging rules is essential for marketing approval. (PMDA, 000272504.pdf).