Japan | Partial amendment to the Minimum Requirements for Biological Products (1 page(s), in English)

Title of documentPartial amendment to the Minimum Requirements for Biological Products (1 page(s), in English)

DescriptionAmendment of the provisions for Potency test in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Amendment of the provisions for Final bulk and final product in the “Polyethylene Glycol-treated Human Anti-HBs Immunoglobulin”, and for Test procedures in the “Test for Measuring the Potency of Human Anti-HBs Immunoglobulin”.

Notifying member: Japan

Notification: G/TBT/N/JPN/711

Objective tagOther

ObjectiveTo establish the standard for manufacturing process, properties, quality, storage and others of pharmaceuticals to which special attention must be paid for the attainment of public health and sanitation (Biological products)

Documents

• 21_6472_00_e.pdf

Agency responsibleMinistry of Health, Labour and Welfare

Timing:

• Submission: 07/10/2021
• Reception: 07/10/2021
• Distribution: 08/10/2021
• Final date for comments: 07/11/2021
• Proposed date of adoption: N/A