In the UK, a Clinical Trial Authorisation (CTA) from Medicine and Healthcare Products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (CTIMP). For international trials in Europe, an application to the competent authority in each member state is required. Details are specified in Section 2 of EC Guidance CT-1 (PDF, 878 KB).
Prior to submission to the MHRA, each trial must be registered on the European Clinical Trials Database by obtaining a EudraCT number (see station). A fee is also payable to the MHRA (see fees section of the MHRA website).
Detailed information on how to submit the application is available on the MHRA Applying to Conduct a Clinical Trial webpages. The application may be completed via the Integrated Research Application System (IRAS) (also see IRAS station) or directly from the EudraCT Web Site. Applications can now be submitted using the Common European Submission Platform (CESP).
Note: For some first in human trials where certain risk factors are present, the MHRA will seek advice from an Expert Advisory Group before a CTA application can be made.
The Clinical Trial Notification Scheme:
The MHRA will process the application based on the type of the trial (Type A, B or C) as described in Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (PDF).
For certain Type A trials, the Clinical Trial Notification Scheme pages of the MHRA web site describe the process and timelines for the CTA application. Once the application is sent to the MHRA, it will be acknowledged with an accompanying note to say that the trial may go ahead after 14 days from receipt of notification if no objections have been raised. The acknowledgement letter will act as the authorisation.
For Type B and C trials, the notification scheme is not applicable and each application will be fully assessed by the MHRA. They will provide an initial response within 30 days of receipt of a valid application, with an average of 14 days for Phase 1 healthy volunteer studies. The MHRA CTA Page lists the documents required for a valid application.
Pilot to test a combined MHRA-REC approval process:
The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot. The pilot brings together the two organisations’ regulatory approvals, streamlining the process in a way that would fit with the EU’s new Clinical Trial Regulation.
The pilot process requires a single CTIMP application to be submitted for both the CTA and the REC opinion. Applicants then receive a combined communication to request any further information required and a single communication to confirm the final decision.
The CTA Application Flowchart (pdf, 11.82 KB) gives an overview of the application process.
For non-CTIMP research, a Clinical Trials Authorisation is not required.