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  • Item management of accelerated approval is strengthened
  • by Lee, Tak-Sun | translator Choi HeeYoung | Dec 31, 2020 06:20am
The MFDS prepares an amendment to the relevant guidelines to reflect the findings of the parliamentary inspection of the administration
The MFDS has established a policy that it will not approve the extension of the deadline if the clinical trial is unsatisfactory for phase III accelerated approval item.

Periodic reports should be submitted in the middle of Phase III, and surveys will be conducted if necessary for items with no results.

It was to supplement this by creating an internal management guideline for the MFDS in response to the fact that the management of items was insufficient during the last National Assembly audit.

According to industry sources on the 29th, the MFDS recently prepared an amendment to the 'Guidelines for approval and management of drugs with conditions related to clinical trials' and began to collect industry opini
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