With your drug remdesivir receiving FDA approval for Covid-19 treatment, what is the process for getting approval for its usage in the GCC?
The US Food and Drug Administration approval for remdesivir was granted on October 22, 2020. In the GCC, we initiated discussions with national regulatory authorities in May 2020 to identify the most appropriate regulatory pathways for the registration of remdesivir. The current authorisations are at the federal level in each of the GCC countries, with approval already received in the UAE and emergency use authorisation in place in other GCC countries including Saudi Arabia, where the process for a full marketing authorisation approval by the Saudi Food and Drug Authority is in its final step.
While Covid-19 vaccines are receiving heightened attention, are there also several treatment options undergoing trials worldwide?
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