Safety Observer

July 2021

Safety Observer 180

Top stories include: PSURs for COVID-19 Vaccines & New DSUR requirements in the UK and Canada.

Released 09-Jul-2021
Pages 22

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The FDA has published a new Draft Guidance on Safety Reporting Requirements for Clinical Trials, which incorporates the December 2015 Draft Guidance on Safety Assessment for IND Safety Reporting after consideration of the feedback received during earlier consultations.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.

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