COVID-19

Transparency: exceptional measures for COVID-19 medicines

During the COVID-19 pandemic, the European Medicines Agency (EMA) is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation.

EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.

Comparison with standard transparency

Regulatory procedureStandard practiceCOVID-19 medicines
Scientific adviceNo information publishedList of medicines that have received scientific advice or guidance from COVID-ETF published
Compassionate use opinionPublished in Compassionate use after CHMP opinionNews announcement published within 1 day of CHMP opinion
Start of rolling reviewNot applicable News announcement published within 1 day of start of review
Marketing authorisation applicationActive substance and therapeutic area listed in Medicines under evaluationNews announcement published within 1 day of application
Product informationPublished in all EU languages with EPARPublished (in English) within 1 day of positive CHMP opinion; published in other EU languages with EPAR
Publication of European public assessment report (EPAR)Published at least 2 weeks after marketing authorisationPublished within 3 days of marketing authorisation
Risk management plan (RMP)Summary of RMP published

Full body of the RMP (plus Annex 4*) published

*Annex 4 for Veklury will be published with the next upcoming update

Clinical trial dataPublication suspended until further noticePublished on Clinical data website after marketing authorisation
Application for extension of indicationNot announcedNews announcement published within 1 day of application

These measures aim to address the high interest for information and to support global research on COVID-19 medicines. They are in addition to the information EMA normally publishes on human medicines.

EMA may increase transparency of other regulatory procedures.

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