Standards for Marketing Approval of Ophthalmic Medicines in Japan

Standards for Marketing Approval of Ophthalmic Medicines (Japan)

The Standards for Marketing Approval of Ophthalmic Medicines were issued as Notification PB No.623 on July 29, 1986. These standards define regulatory criteria for medicines intended to be applied to the mucous membrane of the eyes to treat eye disease symptoms, as well as products used when inserting contact lenses. Preparations that do not conform to these standards must be supported by efficacy and safety data and justification for combinations. (PMDA, 000272495.pdf).

Scope

Ophthalmic medicines covered under these standards include solutions for topical use in the eye, including ordinary eye drops, antibacterial eye drops, artificial tears, contact lens insertion preparations, and eyewashes. (PMDA, 000272495.pdf).

Active Ingredients

Table I lists active ingredients permitted in ophthalmic medicines. At least one active ingredient from specified columns and groups (e.g., Column A–D, Column F–H, certain groups in Column E and I, and Column J) must be included depending on the category of product (e.g., ordinary eye drops, antibacterial eye drops, artificial tears, etc.). Combinations of ingredients are allowed within defined limits per the table. (PMDA, 000272495.pdf).

Quantities of Active Ingredients

The standards specify maximum concentrations for active ingredients in ophthalmic products. For eyewashes, maximum concentrations are set at one‑tenth of the values listed in Table I. When combining ingredients from certain columns, the sum of fractional concentrations must not exceed specified limits. pH and osmotic pressure requirements are included for artificial tears. (PMDA, 000272495.pdf).

Dosage Forms

Approved dosage forms are ophthalmic solutions, which include both eye drops and eyewashes formulated for application to the eye. (PMDA, 000272495.pdf).

Dosage and Administration

• Ordinary eye drops, antibacterial eye drops, and artificial tears are to be administered 3 to 6 times a day.
• Contact lens insertion preparations must include detailed instructions for use.
• Eyewashes are used 3 to 6 times a day for washing the eyes. (PMDA, 000272495.pdf).

Indications

Indications are defined per category:

• Ordinary eye drops cover symptoms such as conjunctival redness, eyestrain, and irritation.
• Antibacterial eye drops target bacterial conjunctivitis and related infections.
• Artificial tears address dryness and foreign‑body sensation.
• Contact lens preparations facilitate lens insertion.
• Eyewashes are indicated for irrigation and prevention of eye troubles, such as removal of sweat or dust. (PMDA, 000272495.pdf).

Packaging Units

The standards provide maximum container volumes for ophthalmic products:

• Ordinary eye drops, antibacterial eye drops, and artificial tears: 20 mL
• Contact lens insertion preparations: 100 mL
• Eyewashes: 500 mL (PMDA, 000272495.pdf).

Summary

These standards establish the regulatory framework for the marketing approval of ophthalmic medicines in Japan, covering active ingredients, dose limits, dosage forms, administration, indications and packaging rules. Compliance with the specifications in Table I and related conditions is essential for obtaining approval. (PMDA, 000272495.pdf).