When the new legislation is enacted, no clinical trial of a medicinal product for human use may commence in the UK unless:
and
Currently, studies in healthy volunteers in the UK do not require regulatory approval and can commence after an ethics committee has given a favourable opinion. The Directive will require the submission to the Licensing Authority of an application for authorisation and a favourable ethics committee opinion before a healthy volunteer trial can commence. The information required, format and procedures involved for all such submissions are the subject of guidance, currently under consultation. MHRA has agreed to respond to a request for authorisation for a Phase I healthy volunteer study in an average of 14 days and no later than 21 days. 1
The application for authorisation will take the form of a Clinical Trial Authorisation (CTA) form which the sponsor will be required to submit to the MHRA before a study can commence. Richmond Pharmacology can provide this service if required, working with the sponsor company, as the legal representative, to complete and submit the CTA form on their behalf. For a list of information required to complete the CTA form see Appendix 1.
An Investigational Medicinal Product Dossier (IMPD) should be submitted with the CTA form as part of the application process. This would usually be handled by the regulatory division of the sponsor company however Richmond Pharmacology can manage this process with some input required from the sponsor.
Application for Clinical Trials Authorisation will also include the following documents amongst others:
To ensure a timely start to the study Richmond Pharmacology will co-ordinate the timing of the MHRA application and the Ethics Committee approval wherever possible.