UK MHRA will accept SUSARs in e-format only from 1 Sept

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.

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.

The agency has set up a new eSUSAR reporting facility that can be used by all sponsors and institutions responsible for safety reporting in clinical trials and it is encouraging sponsors to submit all UK relevant SUSAR reports electronically “with immediate effect”

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