Clinical trial authorisations: Applying for authorisation to conduct a clinical trial - Initial application

1. 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.

2. Where to apply?
Applicants should submit electronic documents on disk, with one PDF file for each document. All disks should be sent to:

Information Processing Unit
Area 6
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

3. What to send?
A request for a clinical trial authorisation consists of:

• Covering letter
• The completed Clinical Trial Application Form
• Protocol
• IMPD or SmPC where relevant
• The specified particulars and documents (supporting data)
• The XML file of application form (complete data set)
• Applicable fee
  

The application form should be completed using the EudraCT database, EudraCT: European Clinical Trials Database (external link) and saved to your computer as an XML file. If you are submitting your application on disk, the signature page must be signed and scanned onto the disk. For full details on how to make a submission please refer to the Making clinical trial submissions section.

Information on the pharmaceutical data required in a CTA is available in the Commission ‘Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials’. (external link)

Further information regarding the requirements for a clinical trial authorisation can be found in Attachment 1 of Detailed Guidance for the request for authorisation of a clinical trial product for human use to the Competent Authorities, notification of substantial amendments and declaration of the end of the trial (external link).

Information on the labelling requirements for investigational medicinal products to be used in a clinical trial can be found in Annex 13 of Volume 4 of The Rules Governing Medicinal Products in the EU: Good Manufacturing Practices. Regulation 46 (external link) of The Medicines for Human Use (Clinical Trial) Regulations 2004 (external link) allows for a particular situation where specific trial labelling is not required. This applies to trials of marketed products being used in certain situations.

If you refer to previously authorised clinical trials in your application, please quote the EudraCT number, CTA number, protocol code and product name.

4. How many copies?
One copy of the application form and supporting data should be provided.
Separate PDF files should be provided for each separate document included

5. Where to get a EudraCT number?
A EudraCT number is a unique number used to identify the trial. One number is issued per protocol, irrespective of the number of trial sites or countries involved. The EudraCT number must be provided for all submissions to the MHRA.

Before submitting the application you have to get a EudraCT number. This is obtained from the EudraCT database (external link). The CTA application form can be completed at the same site and saved as an XML file. This should be sent as part of the application.

6. How do I pay the fees?
Information on the fees and how to pay them can be found on the Fees section.

7. Do I have to apply anywhere else?
All clinical trials also require a favourable opinion from an Ethics Committee. For information on Ethics Committees, please see the Central Office for Research Ethics Committees (COREC) website (external link). The Gene Therapy Advisory Committee (GTAC) (external link) is the Ethics Committee for gene therapy.

Depending of the type of product you may also need to make an application to other bodies. Examples are trials with genetically modified organisms (Contained use of genetically modified organisms (GMOs) (external link)  for contained use activities and Defra  (Department for Environment, Food and Rural Affairs) regulate deliberate release activities, radioactive substances (The Administration of Radioactive Substances Advisory Committee (ARSAC) (external link), or involving medical devices (please see our Clinical trials for medical devices section).

8. What happens next?
The CTA will be validated on receipt and an acknowledgement letter will be sent to the person submitting the application. This is the person named in Section C of the Clinical Trial Application Form. If the application is valid then the assessment period will begin. This starts from the date of receipt of a valid application. If the application is not valid then the person making the application will be told of the deficiencies. Nothing will happen to the application until the missing components are provided.

9. What is the timeframe?
The initial assessment will be performed within 30 days. For the purposes of this calculation, the day of receipt of the application by the Clinical Trials Unit is day 0. Applications for Phase 1 healthy volunteer studies will be assessed and processed within an average of 14 days or less. Further information on the timescales and possible outcomes of applications can be found in our Timescales and outcomes - initial applications section.

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

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

Further information on the timescales and possible outcomes of applications can be found in our Timescales and outcomes - initial applications section.

11. Contact for further information
All queries relating to submissions should be directed to: RIS.CT@mhra.gsi.gov.uk

For questions on the legislation, contact: clintrialhelpline@mhra.gsi.gov.uk