Safety Observer

March 2022

Safety Observer 187

The EMA has revised its RMP guidance for COVID-19 vaccines with updated requirements for Summary Safety Reports.

Released 09-Mar-2022
Pages 29

Report 187 — Highlights

EU Standard for ePI

European Authorities have adopted a Common Standard for electronic Product Information (ePI), which will support the provision of harmonised and up-to-date information on medicines.


The EMA has initiated the establishment of DARWIN EU, which is intended to provide EU Authorities with valid and trustworthy real-world evidence through a network of real-world data sources.

RMP & COVID-19 Vaccines

The EMA has revised its guidance on Risk Management Plans (RMPs) for COVID-19 vaccines. The updates concern the requirements for summary safety reports, including their content and frequency.

CIOMS & Patient Involvement

CIOMS launched a public consultation on a new draft report, which provides “best practices” for the involvement of patients in various aspects of medicine development, regulation, and safety.

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