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Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
May 15, 2025
Approximately 5 minutes
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).
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