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Utilizing RWD for Re-evaluation of Old Drugs

By Lee, Hye-Kyung | translator Choi HeeYoung

22.04.15 06:18:10

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Limits to maintaining validation permits without clinical data

Need to establish procedures


Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation.

The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1.

At the time of approval, Blistop was awarded to the eight major foreign drug formularies, allowing item approval without clinical data.

However, with the recent revision of the permit regulations, it is impossible to permit drug formalities alone, and efficacy evaluation standard of "old drugs" used in the field for decades without efficacy

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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