The Korea Food and Drug Administration (KFDA) held a meeting to discuss regulatory improvements and gather feedback from industry representatives.
On June 19, the KFDA announced that it hosted a meeting at the LW Convention Center in Jung-gu, Seoul, focusing on innovations in the approval and review processes for new drugs and medical products. The meeting aimed to share development directions for the approval and review system with representatives from major companies in the fields of new drugs, biosimilars, and innovative medical devices, while also soliciting industry input.
The KFDA outlined several key initiatives for the innovation of medical product approval and review, including the development and provision of a checklist for proactive regulatory support during the preparation stage of approval documents, the introduction of pre-application meetings to enhance predictability and communication just before the application stage, and the implementation of concurrent and parallel reviews of evaluation items during the approval and review phase to allow for ongoing assessments and a supplementary system.
Industry representatives suggested that the KFDA strengthen the expertise of review personnel to enhance the credibility of the 240-day approval and review innovation plan. They also requested the expansion of mutual recognition agreements with global regulatory agencies to facilitate the international market entry of high-quality domestic medical products. Previously, the KFDA had hired 195 new personnel to bolster its review workforce.
Oh Yu-kyung, head of the KFDA, emphasized, "Through these innovative measures, we aim to enhance the global competitiveness of the domestic biohealth industry. We will ensure that the innovation of medical product approval and review is carried out without any setbacks, based on thorough verification of safety and efficacy."
* This article has been translated by AI.
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