CTA submission now only accepted via Common European Submission Platform (CESP)
From 1 February 2016 the MHRA will no longer accept submissions on physical media (CD/DVD/Letters); only submissions using the [URL="http://cesp.hma.eu/home/index"]Common European Submission Platform (CESP)[/URL] will be accepted. This is in relation to any new CTA submissions along with substantial amendments, and DSURs etc.
There was a consultation regarding physical media. For information, please see the link below relating to the ‘consultation’ outcome:
[URL="https://www.gov.uk/government/news/mhra-to-phase-out-regulatory-submissions-for-medicines-on-physical-media"]https://www.gov.uk/government/news/mhra-to-phase-out-regulatory-submissions-for-medicines-on-physical-media[/URL]
It is expected that in the long run CESP should be easier, quicker and more cost-effective for sponsors. Further information can be found on the MHRA CTU [URL="https://www.gov.uk/government/collections/clinical-trials-for-medicines"]website[/URL].
Any questions regarding CESP should be directed to the clinical trial helpline ([EMAIL="ctdhelpline@mhra.gsi.gov.uk"]ctdhelpline@mhra.gsi.gov.uk[/EMAIL]).