Electronic SUSAR Reporting
All UK relevant SUSAR reports should now be submitted to the MHRA electronically. A three month transition period will run, during which non-electronic reporting methods will continue to operate. On 1 September 2010, all non-electronic methods of SUSAR reporting will be turned off. Sponsors are encouraged to report electronically as soon as possible, as non-electronic routes do not conform to the ICH E2B standard.
For more information on electronic reporting, visit the MHRA ‘Safety reporting –SUSARs and ASRs’ page.
Published Date: 16 July 2010