TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1231

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed amendments to the “Regulations on Fees for Pharmaceutical Approvals, etc.”

Objective

Other (TBT)

Product Covered

Pharmaceuticals

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

The Proposed amendments to the “Regulations on Fees for Pharmaceutical Approvals, etc.” are as follows:A. Increase in fees for application of new drug approval and preliminary review (Annex 1,3,5 and 26 of the Draft)- To expand the human resources with high quality and ability for approval review and facilitate rapid approval of new drug and give patients expeditious access to innovative health care by increasing fees for new drug approval and review.B. Fee reduction of new drug for SMEs (Newly established Article 2(4) of the Draft)_x000D_
- To support the domestic new drug development by discounting 50% of such fee for the drug developed and manufactured in Korea by small and medium-sized enterprises regardless of the increase in the fees for new drug approval and review.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/KOR/1231

Link to ePing

App Settings