Standards for Marketing Approval of Enemas in Japan

Standards for Marketing Approval of Enemas (Japan)

The Standards for Marketing Approval of Enemas were issued by the Pharmaceuticals and Medical Devices Agency of Japan under Notification PB No.94 on February 1, 1988 and finally revised on May 15, 1998. These standards define the regulatory criteria for medicines for rectal application formulated to treat constipation. Preparations not conforming to these standards require submission of efficacy and safety data and justification for combinations. (PMDA, 000272497.pdf).

Scope

These standards apply to enemas intended for rectal administration to relieve constipation. (PMDA, 000272497.pdf).

Active Ingredients

• For liquid preparations, active ingredient types are listed in Table 1, and glycerin must be included from Column I. Column II ingredients (e.g., D‑sorbitol) may be combined with Column I.
• For suppositories, active ingredients are listed in Table 2, and must include ingredients from Column I or Column II, but ingredients from both columns cannot be used together in the same preparation. (PMDA, 000272497.pdf).

Quantities of Active Ingredients

• Maximum and minimum single doses for listed active ingredients are specified in Tables 1 and 2.
• For liquid enemas, glycerin concentration must be 42 % to 50 % if not diluted. (PMDA, 000272497.pdf).

Dosage Forms

Approved dosage forms are liquid enemas and suppositories. (PMDA, 000272497.pdf).

Dosage and Administration

• Liquid preparations: If dilution is required, add water to achieve glycerin concentration of 42 % to 50 %. If one administration does not work, repeat the same dose.
• Suppositories: If one suppository is ineffective, insert another. For suppositories containing Column II ingredients (e.g., bisacodyl), the daily total dose is limited to 0.02 g.
• Children under 3 years: not approved. For ages under 12, single doses are adjusted by age coefficients in Tables 3–5. (PMDA, 000272497.pdf).

Indications

The indication for approved enemas is limited to constipation. (PMDA, 000272497.pdf).

Summary

These standards provide the regulatory framework for approval of enemas in Japan, specifying ingredient inclusion, dose limits, dosage form restrictions, administration guidance, and indications to ensure safety and efficacy. (PMDA, 000272497.pdf).