From 1 February 2016 the MHRA will no longer accept submissions on physical media (CD/DVD/Letters); only submissions using the Common European Submission Platform (CESP) 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:
https://www.gov.uk/government/news/m...physical-media

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 website.

Any questions regarding CESP should be directed to the clinical trial helpline (ctdhelpline@mhra.gsi.gov.uk).