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Notification Detail :: G/TBT/N/KOR/1230
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Proposed partial amendments to the ”Regulation on Approval and Review of Advanced Biological Products”
Objective
Protection of human health or safety (TBT)
Product Covered
Advanced Biological Products
Document Notification
Link to ePing
HSCODE
ICSCODE
11.120 - Pharmaceutics
Keywords
Human health
Specific Regions
Additional Data
Description
The proposed amendments to the ” Regulation on Approval and Review of Advanced Biological Products” are as follows:_x000D_ 1) Providing criteria for exemption from submission of certificate of pharmaceutical product_x000D_ 2) Acceptance of submission of non-clinical test data using alternative animal testing_x000D_ 3) Providing grounds for accelerated review of new drugs
Notified Document
1:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
Active
Inactive
Comment
No
#
Comment By
Title
Comment Date
File
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