UK Retiring eSUSAR Portal For Reporting Clinical Trial Safety Issues
Study sponsors still using the MHRA’s eSUSAR website for trial safety reporting are being urged to update their processes by 30 September.
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The UK Medicines and Healthcare products Regulatory Agency will as of 1 September 2010 accept only electronic submissions of reports of suspected unexpected serious adverse reactions (SUSARs) that occur during pharmaceutical clinical trials1.
Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.
A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.