Transparency: exceptional measures for COVID-19 medicines
Table of contents
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.
|Regulatory procedure||Standard practice||COVID-19 medicines|
|Scientific advice||No information published||List of medicines that have received scientific advice or guidance from COVID-ETF published|
|Compassionate use opinion||Published in Compassionate use after CHMP opinion||News announcement published within 1 day of CHMP opinion|
|Start of rolling review||Not applicable||News announcement published within 1 day of start of review|
|Marketing authorisation application||Active substance and therapeutic area listed in Medicines under evaluation||News announcement published within 1 day of application|
|Product information||Published in all EU languages with EPAR||Published (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 authorisation||Published within 3 days of marketing authorisation|
|Risk management plan (RMP)||Summary of RMP published|
Full body of the RMP (plus Annex 4*) published
|Clinical trial data||Publication suspended until further notice||Published on Clinical data website after marketing authorisation|
|Application for extension of indication||Not announced||News 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.