Clinical trials of investigational medicinal products (CTIMPs) conducted in the UK require 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.
The MHRA provides a notification scheme for certain lower-risk trials, defined as ‘Type A’ trials. These are trials involving medicinal products licensed in any EU Member State if:
- they relate to the licensed range of indications, dosage and form
- or, they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.
Preparation of application for CTA
Applications to MHRA for CTA can be prepared using IRAS. Alternatively, applicants may enter the data required for the application using the EudraCT website.
Submitting application for CTA
Applications should be sent on disk with files following a specific format and naming convention. Applications, other than the notification scheme, incur a fee. For more information and detailed guidance about submitting your application, please refer to the MHRA website.
Coordination of CTA application and NHS REC review
Applications for CTA may be made in parallel with the application for ethical review. A EudraCT number must be obtained from the EudraCT website and included with both applications.