MHRA Guidance on Submitting Clinical Trial Safety Reports

On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).

Company must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways:

  • using the eSUSAR website
  • using the ICSR Submissions
  • using the MHRA Gateway

If company intends to submit SUSARs using one of the new reporting routes, it must register first.

For trials ongoing in both the UK and in European member states, dual reporting is needed. Company will need to report each SUSAR to both the MHRA and to the EMA’s Eudravigilance Clinical Trial Module (EVCTM).

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