TBT BSN | Notification

Notification Detail :: G/TBT/N/JPN/795

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Partial Amendment of the Act on the Safety of Regenerative Medicine

Objective

Protection of human health or safety (TBT)

Product Covered

Nucleic acid, etc. (HS:30)

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Human health

Specific Regions

Description

Under the current Act on the Safety of Regenerative Medicine, when entrusting the manufacturing of processed cells used in regenerative medicine to a business which manufactures them in a foreign country, it is limited to a business which has obtained accreditation by the Minister of Health, Labour and Welfare prescribed in the Act.Gene therapy, etc. which does not use processed cells (medical care which uses nucleic acid, etc.) will be added to the scope of the Act, due to the partial amendment of the Act. Therefore, when entrusting the manufacturing of nucleic acid, etc. used for such medical care to a business which manufactures them in a foreign country, it is limited to a business which has obtained accreditation by the Minister of Health, Labour and Welfare prescribed in the Act as well as processed cells used in regenerative medicine.

Notified Document

1:File here

Link to Notification

EN:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/JPN/795

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