Safety observer has shared the document that highlights impact on Safety Reporting procedures for both Clinical Trial and Post-Marketing Pharmacovigilance activities due to Covid-19.
Most of the authorities have published guidance documents during this pandemic that have been related to the conduct of Clinical Trials, and intended to protect subject safety and data validity and the impact for Pharmacovigilance groups.
There were communication from webinar that held by the European Commission on 15-May-2020 to provide an overview of the most important elements of its Guidance on the management of clinical trials during the COVID-19 pandemic and a few National Competent Authorities (e.g. France, the UK) have however published guidance to express their understanding that safety reporting timelines may not always be met, and that SUSARs submissions should have priority over periodic safety reports. Both the EMA and FDA have published guidance to help with the statistical analysis of trials impacted by COVID-19. EMA has published guidance that describes how companies can prioritise ICSR Reporting activities. The MHRA has defined regulatory flexibility for certain Pharmacovigilance requirements including PSUR Submission, Safety Variations, dissemination of educational materials and DHPCs. The MHRA has also defined an urgent review procedure for the Relaxation of Risk Minimisation Measures. The FDA and Health Canada have published guidance that provides a framework to delay the submission of some reports, including ICSRs for non-priority products. The FDA has issued an updated version of its guidance on 11-May-2020, which brought important changes for the prioritization of 15-day Alert reports that should be submitted to the FDA.
The FDA has also expressed their understanding that some REMS requirements may not be met during the Public Health Emergency.
You can download compiled updates from below link:
https://safetyobserver.blogspot.com/2020/04/covid-19-guidance-impact-for_9.html?m=1
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