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  • The re-evaluation of ¥á-GPC will be implemented next month
  • by Lee, Tak-Sun | translator Choi HeeYoung | Nov 11, 2020 08:48am
Expect a reasonable plan, no opinions have been received so far
It seems that it is possible to determine whether the indication is maintained after application
The MFDS stated that the clinical re-evaluation schedule of the brain function improving drug, Choline alfoscerate has not changed.

The clinical plan must be submitted by the 23rd of next month. If the deadline is not met, the sale will be suspended immediately.

Shin Seung-seung, an official of the Drug Safety Assessment Division of the MFDS, met with a reporter on the 10th and said this. She explained, "The companies must submit a reasonable plan to recruit enough subjects, it is about 90 days until the plan is reviewed, and it may be extended if supplementation comes out."

In principle, the MFDS is in the position that all indications for Choline alfoscerate should undergo clinical reevaluation. However, if
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