Academic trials: General information

When is a clinical trial authorisation (CTA) required?
A clinical trial authorisation (CTA) is required for trials of medicinal products. This includes trials where the medicinal product is used in the comparator rather than in test arm and where the test product is a marketed product being used within the terms of its marketing authorisation.

Clinical studies involving only medical devices, food supplements or other non-medicinal therapies (such as surgical interventions) are not covered by the clinical trials legislation in The Medicines for Human Use (Clinical Trial) Regulations 2004 (external link).

Similarly, these regulations do not apply to non-interventional trials. In such trials, no additional diagnostic or monitoring procedure should be applied. Epidemiological methods should be used for the data analysis.

Further information on when a clinical trial authorisation is required can be found in the is a CTA required? section.

Who can apply?
The application must be made by the sponsor or by someone authorised to submit the request on his behalf. If the sponsor is not established in the European Community then he must have a legal representative who is so established.
 

What should I send?
Full details on what to send and how the data package should be submitted can be found in the following sections:

applying for a CTA: what to send section

applying for a CTA: additional Information

academic trials: additional Information

Does my application require expert advice?
For certain trials, we will seek advice from an Expert Advisory Group (EAG) (the Commission on Human Medicines) before approval for the trial can be given. The decision to refer applications for expert advice will be based on assessment of risk factors and the proposed mitigation strategy. Areas for consideration when determining risk factors include mode of action, nature of the target and the relevance of animal species and models.

Examples of trials where expert advice may be sought include first-in-human trials with novel compounds:

• where the mode of action involves a target that is connected to multiple signalling pathways (target with pleiotropic effects) eg leading to various physiological effects or targets that are ubiquitously expressed
• acting (directly or indirectly) via a cascade system where there may be an amplification effect which might not be sufficiently controlled by a physiological feedback mechanism
• acting (directly or indirectly) via the immune system with a target or mechanism of action which is novel or currently not well characterised
• where there is novelty in the structure of the active substance eg a new type of engineered structural format such as those with enhanced receptor interaction as compared with the parent compound
• where the level of expression and biological function of the target receptor may differ between healthy individuals and patients with the relevant disease
• where there is insufficient available knowledge of the structure, tissue distribution, cell specificity, disease specificity, regulation, level of expression and biological function of the human target, including down-stream effects
• acting via a possible or likely species specific mechanism or where animal data are unlikely to be predictive of activity in humans

Further information can be found in the expert advice section.

What are the fees and how do I pay them?
Information on the fees and how to pay them can be found in the fees section.

How is an application submitted?
Applicants are required to submit electronic documents on disk with one PDF file for each document. In exceptional cases where the use of PDF files is not feasible, (for example, in the case of small, non-commercial clinical trials) electronic documents using Word are acceptable and will be processed to the same target timescales. Disks should be submitted with no subdirectory structure. The portal is not available for clinical trial submissions at this time. Updates on portal availability will be provided in due course.

Each disk should be labelled in the following manner:

• EudraCT number
• Description of contents eg:
• • Initial Application
  • Response to Remarks from an Initial Application
• Company name
• Date sent

The disk may be printed or labelled with an adhesive paper label or a permanent marker pen.

All disks should be sent to the address below:

Information Processing Unit
Area 6
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
Victoria
SW1W 9SZ

What happens next?
When the MHRA receives an application for a clinical trial authorisation (CTA), it will be validated. If the application is not valid (eg incomplete information is supplied) then the person making the application will be contacted and told that there are deficiencies. If the deficiencies are minor, you may be asked to provide the missing information. Nothing will happen to the application until the missing components are provided, although once the application is complete it will be processed as normal.

If the deficiencies are major, you may be required to resubmit a complete application. If the application is valid (ie complete), then the assessment period will begin and an acknowledgement letter will be sent to the person submitting the application. This is the person named in section C1 of the clinical trial application form.

The assessment period starts from the date of receipt of a valid application. If you have not been told that your application is invalid or received an acknowledgement letter within 10 days of sending the application, please contact RIS.CT@mhra.gsi.gov.uk

What are the possible outcomes?
When the application has been assessed (within 30 days) the applicant will be sent a letter informing them of one of the following:

1. acceptance of the request for a clinical trial authorisation
2. acceptance of the request for a clinical trial authorisation subject to conditions
3. grounds for non-acceptance of the request for a clinical trial authorisation.

If you have not received a letter within 35 days of sending the application, please contact RIS.CT@mhra.gsi.gov.uk.