Standards for Marketing Approval of Nasal Drops for Rhinitis in Japan

Standards for Marketing Approval of Nasal Drops for Rhinitis (Japan)

The Standards for Marketing Approval of Nasal Drops for Rhinitis were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.109 on February 1, 1991, with final revision on January 19, 2012. These standards define criteria for intranasal preparations intended for the relief of symptoms due to rhinitis. Preparations that do not conform to these standards must be supported by efficacy and safety data and justification for combinations. (PMDA, 000272499.pdf).

Scope

These standards apply to intranasally‑applied liquid medicines formulated for alleviating symptoms of acute rhinitis, allergic rhinitis and sinusitis. (PMDA, 000272499.pdf).

Active Ingredients

• Permissible active ingredients are listed in Table 1, including vasoconstrictors and other agents.
• Preparations must include at least one active ingredient from Column I of Table 1.
• Active ingredients from different columns may be combined, but only one ingredient per column I–IV is permitted when used together. (PMDA, 000272499.pdf).

Quantities of Active Ingredients

• Maximum concentrations for each ingredient are specified in Table 1.
• Minimum concentrations for Column I ingredients are half of the respective maximum; for other columns, minimum concentrations are one‑fifth of the respective maximum. (PMDA, 000272499.pdf).

Dosage Form

The dosage form covered by these standards is intranasally‑applied liquid preparations intended for nasal use. (PMDA, 000272499.pdf).

Dosage and Administration

• Preparations are to be applied intranasally no more than six times a day.
• Application method and intervals must be clearly stated, with intervals of at least 3 hours between uses.
• Dosages for infants under 2 years of age are not approved.
• For children under 7 years, the maximum concentrations may be half of the standard maximum concentrations. (PMDA, 000272499.pdf).

Indications

Indications must fall within relief of symptoms due to acute rhinitis, allergic rhinitis or sinusitis: stuffy nose, runny nose (excess nasal discharge), sneezing and dull headache (heaviness in head). (PMDA, 000272499.pdf).

Packaging Units

The maximum volume of containers for intranasal liquids is limited to 30 mL. (PMDA, 000272499.pdf).

Summary

These standards provide the regulatory framework for approval of nasal drops for rhinitis in Japan, covering ingredient types, concentrations, dosage forms, dosing instructions, indications, and packaging limits to ensure safety and efficacy. (PMDA, 000272499.pdf).