EMA Clarifies Fast-Track Mechanisms For COVID-19 Medicines & Vaccines
From speeding up PIP agreements to starting rolling reviews, the European Medicines Agency has explained how it is accelerating its regulatory procedures for COVID-19 treatments and vaccines.
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EMA advises caution on COVID-19 vaccine timelines, but says the outlook is more promising for new treatments.
Results from the US ACCT study have led both the EMA and the FDA to accelerate the review of Gilead’s remdesivir for use in coronavirus patients. The EMA says it will also take account of the results of a Chinese study that found the antiviral was “not associated with statistically significant clinical benefits.”
Recommendations from the European Medicines Agency explain the conditions under which early access to remdesivir could be given through compassionate use programs.