Clinical trials application

Question 2

EU Clinical Trial Regulation (CTR)

Answer 2

not implemented before the end of the Brexit Transition period
* Not automatically translated into UK law
* UK no longer has access to CTIS or EudraCT database
○ UK will align with the parts of the EU’s CTR legislation that are within the UK’s control
○ Separate CTA application required in the UK
* Sponsor may be in UK or EU

Question 3

Combined Review Service for CT applications mandatory from 1 January 2022

Answer 3

• Allows sponsors to voluntarily apply to obtain a joint decision on the ethical and regulatory approval of their CTA
  
  • Initially part of UK preparation for implementation of EU CT Regulation 536/2014
    ○ Submissions to be made via the Integrated Research Application System (IRAS)
  • Combined Review Service in IRAS available from 31 August 2021

Question 4

UK CT application process from 01 Jan 2021

Answer 4

Get EudraCT number
Complete application form in IRAS
Download application form
Submit via MHRA submissions
MHRA validates application
MHRA communicates and RFI / decision directly to the applicant

Question 5

Brexit impacts on the CT application process

Answer 5

For IMPs moved from GB to EU:
CTA held by legal entity in EU
Need EU QP to certify the batches
UK will not have access to EudraCT and CTIS database
QP can be resident in EEA
Named on UK MIA(IMP)

For IMPs moving from EU to UK:
No need for UK QP to certify IMPs from EU - UK QP to confirm EU certification
Need separate GB CTA - UK IRAS portal
IMP only shipped to trial sites in GB CTA
UK will continue to recognise pre-2021 regulatory and ethics approvals
Safety reporting: SUSAR reports to be sent to MHRA