Under the EU Clinical Trials Directive 2001/20/EC and the Medicines
for Human Use (Clinical Trials) Regulations 2004, which transposed the
Directive into UK law, any CTIMP conducted in the UK requires both
clinical trial authorisation (CTA) from the Medicines and Healthcare
products Regulatory Agency (MHRA) and a favourable opinion from an
ethics committee.
The MHRA is responsible for advising on the Regulations and
requirements for CTA. Detailed guidance is available on the MHRA website. Section 2 of this guidance
links to an algorithm to help you decide whether or not your research is
a CTIMP. The page also contains contact details if you remain unsure
after checking the algorithm.
Applications to MHRA for CTA can be prepared using IRAS.
Alternatively, applicants may enter the data required for the
application using the EudraCT
website.
Applications for CTA may be made either in parallel or in sequence
with the application for ethical review. A EudraCT number must be obtained from the
EudraCT website and included with both applications.
