EMA issues overview of fast track procedures for COVID-19 treatments and vaccines

The EMA published (4 May, 2020) an overview of how it will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.

“Supporting the development and marketing authorisation of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency. Together with our scientific committees and working parties, we have adapted our procedures in order to significantly shorten our own regulatory timelines for the review of new medicines and vaccines against COVID-19,” said Executive Director Guido Rasi. “However, the rapid approval of therapeutics and vaccines will only be possible if applications are supported by robust and sound scientific evidence that allows EMA to conclude on a positive benefit-risk balance for these products.”

Read the full document here: EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines