원문정보
초록
영어
Nowadays, the consumption of botulinum toxin products has been steeply increased in both clinical objective and cosmetic objective. Also the indication of botulinum toxin has been expanded over cervical dystonia to prostatism , migrein and other nuerological disease such as Parkinson's disease. In Korea, four products of botulinum toxin are launched in market and several companies are trying to acquire the approval of their new botulinum products. To develop and provide safe and effective products, it is very important to control the quality of products at several stages such as initial researches, development, production, and lot release testing.
In this presentation, first the status and prospece of botulinum product will be introduced. Secondly, how to control the quality of botulinum products will be showed in the regulatory perspective of KFDA.