Safety Observer 180
Top stories include: PSURs for COVID-19 Vaccines & New DSUR requirements in the UK and Canada.
Report 180 — Highlights
PSURs for COVID-19 Vaccines
The EMA has published new guidance to address specific considerations for PSURs, which specifies additional requirements for COVID-19 Vaccines.
MHRA, Health Canada and DSURs
The MHRA and Health Canada have jointly published a new guidance document that requires DSURs to describe how each signal was evaluated in the region-specific information section of the DSUR.
FDA Trial Safety Reporting
The FDA has published a new Draft Guidance on Safety Reporting Requirements for Clinical Trials, which incorporates the December 2015 Draft Guidance on Safety Assessment for IND Safety Reporting after consideration of the feedback received during earlier consultations.
EMA consults on ePI
The EMA has launched a new public consultation on the proposed Common EU Standard for electronic Product Information (ePI), which is intended to be used for medicines across the EU.
ANSM and PV in Compassionate Use
The schemes for Compassionate Use have been revised in France and the French Agency has published a series of Q&As to clarify Pharmacovigilance requirements associated to these programmes.
