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
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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