COVID-19
Transparency: exceptional measures for COVID-19 medicines
Throughout the COVID-19 pandemic, the European Medicines Agency (EMA) has implemented 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 achieves this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.
| Standard practice | COVID-19 medicines | |
|---|---|---|
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 |
Active substance and therapeutic area listed in Medicines under evaluation | Vaccine / treatment page updated; news announcements published on case-by-case basis | |
Published and updated in all EU languages with EPAR | ||
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 |
Risk management plan (RMP) | 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 | Vaccine / treatment page updated; news announcements published on case-by-case basis |
Monthly safety updates for vaccines | No information published | Published monthly for approved COVID-19 vaccines (and ad-hoc as needed) between January 2021 and December 2022.* * Periodic Safety Update Reports (PSURs) and their EMA assessments made available from August 2023. |
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 11 March 2022
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.