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 informationit does not normally publish for other medicines.
Comparison with standard transparency
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 | Vaccine / treatment page updated; news announcements published on case-by-case basis |
Product information | 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 |
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 thehigh interest for informationand 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.