Standards for Marketing Approval of Oral Remedies for Rhinitis in Japan

Standards for Marketing Approval of Oral Remedies for Rhinitis (Japan)

The Standards for Marketing Approval of Oral Remedies for Rhinitis were issued by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan under Notification PB No.23 on March 25, 2015, with partial revision on December 14, 2015. These standards define criteria for approval of oral medicines intended to relieve rhinitis symptoms, excluding cold remedies, anti‑allergic agents and Kampo‑based remedies. Remedies that do not conform to these standards require submission of efficacy and safety data and justification for combinations. (PMDA, 000272491.pdf).

Scope

The standards apply to oral medicines formulated to relieve symptoms of rhinitis; cold remedies, anti‑allergic agents and Kampo‑based formulas are excluded. (PMDA, 000272491.pdf).

Active Ingredients

Table 1 in the standards lists active ingredients permitted for use and categorizes them into Columns I to V, with specific rules on combinations: only one ingredient from certain columns may be used in combination, and some combinations are prohibited (e.g., dl‑methylephedrine hydrochloride with l‑methylephedrine hydrochloride). (PMDA, 000272491.pdf).

Quantities of Active Ingredients

The maximum daily dose for each active ingredient is specified in Table 1. The maximum single dose is one‑third of the maximum daily amount, except oral solutions and syrups where it is one‑sixth. When combining certain ingredients, the sum of dose fractions must not exceed specified limits. Lower limits for daily doses also apply based on ingredient column. (PMDA, 000272491.pdf).

Dosage Forms

Approved dosage forms include capsules, granules, pills, powders, tablets, oral solutions (excluding elixirs) and syrups. (PMDA, 000272491.pdf).

Dosage and Administration

The general regimen is oral dosing three times a day, with intervals of at least four hours. For oral solutions and syrups, dosing up to six times per day is acceptable if taken at approximately four‑hour intervals. Dosage for infants under 3 months is not approved. Age‑ and formulation‑based restrictions apply for children, with maximum daily doses adjusted by age coefficients. The maximum single dose for oral solutions and syrups is 10 mL. (PMDA, 000272491.pdf).

Indications

Indications must fall within relief of symptoms due to acute rhinitis, allergic rhinitis or sinusitis, including sneezing, runny nose (excessive nasal discharge), stuffy nose, watery eyes, sore throat and dull headache. (PMDA, 000272491.pdf).

Packaging Units

The maximum volume for containers of oral solutions and syrups is limited to a four‑day supply at the maximum daily dose. (PMDA, 000272491.pdf).

Summary

These standards form the regulatory framework for marketing approval of oral rhinitis remedies in Japan. Compliance with active ingredient lists, dosage limits, dosage forms, administration regimens, indications and packaging rules is essential to obtain approval. (PMDA, 000272491.pdf).