On March 31, 2026, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued MHLW Notification No. 155, revising the standards and requirements for ruminant-derived raw materials under the Standards for Biological Raw Materials. The relevant amendments apply to pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medical products. The revisions became effective on the date of issuance.
Background
The Minister of Health, Labour and Welfare has established the Standards for Biological Raw Materials ("the Standards") pursuant to the Law on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, etc. The Standards prescribe necessary measures to be taken when using raw materials derived from humans and other living organisms (excluding plants) in the manufacturing of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medical products (hereinafter collectively referred to as "Pharmaceuticals, etc."), including materials used as additives, culture media, and other substances in the manufacturing process.
Under the Standards, specifically Section 4, Paragraph 1 (Standards for Ruminant-Derived Raw Materials), provisions specify prohibited anatomical parts and permissible countries of origin for raw materials derived from ruminant animals such as cattle. The use of raw materials that do not comply with these standards is principally prohibited in the manufacture and sale of Pharmaceuticals, etc.
In the "Pharmaceuticals and Medical Devices Regulatory Harmonization and Evaluation Research Project" conducted by relevant institutions during fiscal years 2022-2024, specific issues and solutions regarding the Standards were examined from the perspective of updating in accordance with new knowledge and technologies and enhancing international harmonization to a reasonable extent. Based on the results summarizing the risk assessment of using certain ruminant-derived parts as raw materials, the Standards are being revised accordingly.
Key Amendments
1. Relaxation of Restrictions on the Use of Backbones and Skulls
- For backbones and skulls derived from ruminant animals such as cattle, which are prohibited for use as raw materials in Pharmaceuticals, etc., use is permitted provided that: the country of origin is classified by the World Organization for Animal Health (WOAH, formerly OIE) as a "negligible BSE risk country" (a country where the risk of pathogen transmission of Bovine Spongiform Encephalopathy (BSE) is considered negligible);
- The materials are derived from cattle aged 30 months or younger.
2. Update of Countries of Origin
- Remove references to materials originating from Canada;
- Delete individual country listings that duplicate countries already recognized by the World Organisation for Animal Health (WOAH) as negligible BSE risk countries.
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