On 23 January 2026, the Ministry of Health, Labour and Welfare (MHLW) of Japan submitted notification G/TBT/N/JPN/898 to the World Trade Organization (WTO), proposing revisions to The Standards for Ruminant-Derived Raw Materials within the Standards for Biological Raw Materials. The proposed amendments apply to drugs, quasi-drugs, cosmetics, medical devices, and regenerative medical products. The proposed date of adoption and entry into force is March 2026.
The Standard for Biological Raw Materials
According to the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Standards for Biological Raw Materials (the notification No.210 of MHLW, 2003) has been notified in order to provide guidance for necessary measuresto be taken when biologicalrawmaterials are used in manufacturing drug, quasi-drug, cosmetic, medical device and regenerative medicine product (hereinafter referred as “drugs, etc.”).
The summary of the amendment
To exclude "backbone" and "skull" derived from cattle aged 30 months or younger from the list of parts prohibited for use as raw materials for drugs, etc.
To update the description regarding the country of origin based on the revision of countries in which the risk of BSE pathogen propagation is considered negligible by the World Organisation for Animal Health, including the removal of references of Canadian-origin materials.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- Cosmetics Notification & Quasi-drug Registration
- Formula and Label Review
- Dossier Preparation
- Testing Required for Notification
Further Information：
WTO
