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  • MFDS cautious about strengthening regulations
  • by Lee, Jeong-Hwan | translator Kim, Jung-Ju | Jun 22, 2023 05:40am
on conditionally approved drugs that require Phase III trial after commercialization
¡°Need to sufficiently listen to opinions to secure receptivity in the industry¡±
The Korean Pharmacists Association for a Healthy Society agrees on the need to strengthen safety management... KRPIA opposes due to the potential increase in labor and time burden
The Ministry of Food and Drug Safety explained that although the MFDS with the purpose of the legislation to strengthen regulations on drugs that have been conditionally approved for expedited marketing authorizations before completing Phase III clinical trials from the current guideline level to the Pharmaceutical Affairs Act level, its application will require ample collection of opinions from stakeholders. In other words, the MFDS has a cautious stance regarding the reinforcement of related regulations.

However, there was also the opinion that mandating all matters related to conditional expedited approval drugs to be decided through the Central Pharmaceutical Affairs Committee could lead to delay and overload
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