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

 Standard practiceCOVID-19 medicines
No information published
List of medicines that have received scientific advice or guidance from COVID-ETF published
Published in Compassionate use after CHMP opinion
News announcement published within 1 day of CHMP opinion
Not applicable 
News announcement published within 1 day of start of review
Active substance and therapeutic area listed in Medicines under evaluation
News announcement published within 1 day of application
Published and updated in all EU languages with EPAR
Published (in English) within 1 day of positive CHMP opinion; published in other EU languages with EPAR.
Updates to be expedited for major post-authorisation changes
Publication of European public assessment report (EPAR)
Published at least 2 weeks after marketing authorisation and updated following changes to the authorisation.
Published as soon as possible and ideally within 7 days of marketing authorisation.* Updates to be expedited for major post-authorisation changes
 
*EPARs can only be published once all necessary steps are completed, which is not always possible within 7 days
Summary of RMP published
Full body of the RMP (plus Annex 4) published. Updated RMPs also published after major post-authorisation changes
Publication suspended until further notice
Trial data published on Clinical data website after marketing authorisation; additional trial data also published after major changes to authorisation
Application for extension of indication
Not announced
News announcement published within 1 day of application
Monthly safety updates for vaccines
No information published
Published monthly for approved COVID-19 vaccines and ad-hoc as needed.
Assessment of safety signals
Information published with PRAC meeting highlights as necessary
Information on start and finalisation of procedure published with PRAC meeting highlights routinely

Last updated 15 January 2021

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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