EMA Spells Out Fast-Track Review Timing for COVID-19 Products

The European Medicines Agency (EMA) said it will cut the review time for potential COVID-19 treatments and vaccines from 210 days to less than 150 days.

The agency also said it will review pediatric investigation plans related to COVID-19 products in 20 days, a significant reduction from the standard review time of 120 days.

In reviewing marketing authorizations for COVID-19 products, the EMA will use a rolling review process, used in emergency situations to evaluate early data for a drug. The agency is  using this process to evaluate Gilead’s remdesivir (DID, May 4).

The emergency processes will remain in place until the pandemic ends, the EMA said.