Japan | Partial amendment to the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices

Title of document
1) Partial amendment to the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and 2) Partial amendment to the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (1 page(s), in English)

Description
The Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement will be partially amended to reflect the World Health Organization (WHO) standard on Summary Lot Protocol (SLP).

Notifying member: Japan

Notification: G/TBT/N/JPN/696

Objective tag
Other

Objective
With regard to National Release Testing of biological pharmaceuticals such as vaccines and blood products by national regulatory authority, an international standard for assessment process of SLP has been provided by WHO. In Japan, the SLP dossiers to be submitted for application of National Release Testing are specified under Article 197, Paragraph 2 of the Regulation for Enforcement, for biological pharmaceuticals designated by the Minister of Health, Labour and Welfare. This partial amendment will extend the designated biological pharmaceuticals to any biological pharmaceuticals.

Documents

• 21_2467_00_e.pdf

Agency responsible
Ministry of Health, Labour and Welfare

Timing:

• Submission: 02/04/2021
• Reception: 06/04/2021
• Distribution: 06/04/2021
• Final date for comments: 05/06/2021
• Proposed date of adoption: N/A