Safety Observer 187
The EMA has revised its RMP guidance for COVID-19 vaccines with updated requirements for Summary Safety Reports.
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.
DARWIN EU
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.
