Clinical trials - Woman in lab

Medicinal products need to have a marketing authorisation granted before they can be sold or supplied to patients. Before this authorisation is granted, information about the product is assessed to ensure that it is safe and effective and also that the quality of the product is sufficient.

Clinical trials are undertaken to allow data on the safety and efficacy of new products to be collected. These trials can be conducted using healthy volunteers or patients, depending on the type of product and its stage of development. Information on the non-clinical safety will have been obtained before the clinical trial programme commences.

Clinical trials begin with small studies in a controlled population of healthy volunteers or patients and, as data are gathered, expand to large scale studies in patients. These large scale studies will often investigate the new product and the currently used treatment to see how these two compare. As information is obtained, larger numbers of patients are exposed to the new product and safety data can be collected showing the safety of the product in the intended patient population.

The Clinical Trials Unit is part of the Licensing Division of the Medicines branch of the MHRA. The role of the Unit is to assess applications from sponsors to conduct clinical trials with medicinal products. The types of trials assessed range from first-in-man studies for new compounds to studies with products which already have marketing authorisations.

The interactive flow diagram below provides a general overview of the process involved in obtaining a clinical trial authorisation (CTA):


         
    Is a Clinical Trial Authorisation (CTA) required?

Yes      No

I don't know
   
    arrow    
Yes left arrow Can I use the notification scheme?

I don't know
Right arrow No
arrow       arrow
Applicant submits a notification

Key documents include:

1. Covering letter
2. Application form [IRAS]
3. EudraCT XML file
4. Protocol
4. IMP dossier/SmPC*
5. Manufacturer's authorisations*
6. Examples of labeling

*As applicable
      Applicant submits a request for authorisation

Key documents include:

1. Covering letter
2. Application form [IRAS]
3. EudraCT XML file
4. Protocol

5. Investigator's Brochure (IB)
6. IMP dossier/SmPC*
7. Manufacturer's authorisations*
8. QP declaration*
9. Examples of labeling

*As applicable
         

Applicant receives acknowledgment letter providing approval of the trial unless an objection is raised by MHRA within 14 days

Right arrow
Objection raised to notification(request is treated as a standard request for authorisation)
  MHRA provides an initial response within 30 days of date of receipt of valid application
down arrow      
No objection to notification – authorisation becomes valid 4 days after receipt of valid application
      down arrow
     
         
         
    down arrow    
         
  down arrow   down arrow  
  CTA application approved   MHRA requests further information

(Grounds for non-acceptance)
 
  ver line   down arrow  
  Substantial amendments to CTA   Applicant submits amended application, usually within 14 days**

More info...
Right arrow
  ver line   down arrow down arrow
  Pharmacovigilance SUSARs and ASRs   Response acceptable        Response not acceptable or no response received
  down arrow   down arrow down arrow
  End of trial declaration   CTA application approved CTA application rejected
resubmit a new application
      ver line
      Substantial amendments to CTA  
    ver line  
      Pharmacovigilance SUSARs and ASRs  
    down arrow  
      End of trial declaration  
         
         

**Regulation 19 of Statutory Instrument 2004 No. 1031: The Medicines for Human Use (Clinical Trials) Regulations 2004 allows for an extended time frame for certain medicinal products (e.g. gene therapy and somatic cell therapy)


Page last modified: 07 November 2012