8th Jan 2016, 09:30 AM
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 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:
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 (firstname.lastname@example.org).