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  • MFDS to review reference drug application every 2 months
  • by Lee, Hye-Kyung | translator Alice Kang | May 20, 2025 05:59am
Will accept applications and notify reference drug changes every 2 months¡¦will have a positive effect on the development of generic drugs
Domestic pharma industry expects the change to bring ease to generic drug development. in korea..expects a practical operation method
The change in the procedure for selecting reference drugs for pharmaceutical equivalence tests is being well received by the domestic pharmaceutical industry.

The Ministry of Food and Drug Safety recently announced a revision to the 'Guideline for Selecting Reference drugs for Pharmaceutical Equivalence Tests' and is seeking opinions on the change, deciding to proceed with the application and announcement of reference drugs every 2 months instead of every quarter.

With the revision of the guideline, reference drug applications will be accepted six times a year (September 16-November 15, November 16-January 15, January 16-March 15, March 16-May 15, May 16-July 15, and July 16-September 15) and reference drugs will b
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