TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/31

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Public Notification of Draft Amendment of "Pharmaceutical law enforcement regulation (35 pages, in Korean)

Objective

Product Covered

Pharmaceuticals etc.

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

Revision of articles related to clinical trials To strengthen the obligation of a clinical trial sponsor -	A clinical trial should begin within 1 year from the approval of clinical trial protocol ; -	A sponsor should provide the clinical trial investigator with a investigation brochure before trial and inform them when new data and information are obtained concerning safety and efficacy -	Completion should be reported within 20 days from the completion of clinical trial Korea Food and Drug Administration can cancel the approval of clinical trial protocol when; -	Trial subject may be exposed to serious disease or damage -	Drugs for clinical trials are distributed for other purpose (i.e. not for clinical trials) To prepared concrete procedures and standards for the bio-equivalence test.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/KOR/31

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