Japan Designates Shitei Yakubutsu for Pharmaceutical and Medical Device Safety

Japan has designated Shitei Yakubutsu as critical substances ensuring quality, efficacy, and safety in pharmaceuticals and medical devices under its 1960 Act

Compliance Analysis: Designation of Shitei Yakubutsu (Designated Substances) under Japan’s Pharmaceutical and Medical Device Act

Direct Answer

Japan designates Shitei Yakubutsu ("designated substances") under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (1960, Law No. 145) to regulate substances with probable effects on the central nervous system, preventing abuse while permitting limited, authorized uses. The Ministry of Health, Labour and Welfare (MHLW) prohibits the manufacture, import, sale, possession, and use of these substances except for explicitly approved purposes^{1, 2, 3}.

Regulation Analysis

1. Legal Framework and Objectives

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter the Act) empowers the MHLW to designate Shitei Yakubutsu to:

• Prevent abuse of substances affecting the central nervous system^{1, 2, 3}.
• Clarify regulatory controls under the Act, ensuring public health and safety^{1, 2, 3}.
• Restrict unauthorized activities while permitting designated "proper uses" (e.g., medical or research applications)^{1, 2, 3}.

Designations are published in Japan’s Official Gazette (KAMPO) upon adoption^{2, 3}.

2. Regulatory Requirements for Shitei Yakubutsu

Prohibited Activities

The Act bans the following for Shitei Yakubutsu unless authorized for "proper uses":

• Manufacture
• Import
• Sale
• Possession (including "simple ownership")
• Use^{1, 2, 3}.

Designation Process

1. Proposal: The MHLW proposes additional substances for designation (e.g., 3 substances in², 4 in¹, 1 in³).
2. Notification: Proposals are circulated via the WTO Technical Barriers to Trade (TBT) Committee under Article 2.10.1 or 2.9.2^{1, 2, 3}.
3. Publication: Adopted designations and "proper uses" are published in the Official Gazette (KAMPO)^{2, 3}.
4. Enforcement: Restrictions take effect on the specified date (e.g., 31 January 2026², 14 March 2026¹, February 2026³).

Key Deadlines and Authorities

*MOFA = Ministry of Foreign Affairs (Japan Enquiry Point)

3. Compliance Obligations

For Businesses and Individuals

• Prohibition: Do not engage in restricted activities (manufacture, import, sale, possession, or use) without MHLW authorization^{1, 2, 3}.
• Due Diligence: Verify whether a substance is designated as Shitei Yakubutsu via the Official Gazette or MHLW notifications^{2, 3}.
• Record-Keeping: Maintain documentation for authorized "proper uses" (e.g., medical or research purposes)^{1, 2, 3}.

For Regulatory Authorities

• Monitoring: The MHLW oversees compliance and may update designations periodically^{1, 2, 3}.
• Enforcement: Violations may result in penalties under the Act (not specified in sources; refer to the Act for details).

4. Stakeholder Engagement

• Comments: Limited to specific notifications (e.g.,³ allows comments until 10 February 2026)³.
• Contact: Japan Enquiry Point (MOFA) for inquiries:
  • Fax: +81 3 5501 8343
  • Email: enquiry@mofa.go.jp^{1, 2, 3}.

Summary Answer

Japan’s Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (1960, Law No. 145) designates Shitei Yakubutsu to regulate substances with central nervous system effects, prohibiting their manufacture, import, sale, possession, and use except for MHLW-approved "proper uses"^{1, 2, 3}. The MHLW periodically proposes new designations (e.g., 3–4 substances per notification^{1, 2}), which are published in the Official Gazette upon adoption and enforced on specified dates (e.g., 31 January 2026², 14 March 2026¹). Compliance requires adherence to restricted activities and verification of substance status via official channels^{1, 2, 3}. Stakeholders may submit comments during designated periods (e.g., 60 days for³) and direct inquiries to the Japan Enquiry Point^{1, 2, 3}.

Sources

1. ↩ Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145) — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN26/JPN903.pdf&Open=True
2. ↩ Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145) — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN26/JPN897.pdf&Open=True
3. ↩ Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145) — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/JPN889.pdf&Open=True