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New UK Notification Scheme for Clinical Trials

Monday the 4th April 2011

The MHRA has launched its new Notification Scheme for clinical trials today (1 April 2011) for medicinal products.

The Notification Scheme is available for trials involving medicinal products authorised in any EU Member State if:

• they relate to the licensed range of indications, dosage and form
• or, they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.

The Notification Scheme will be open to trials meeting the above criteria and may include randomisation of subjects to different marketed products or repackaging and/or relabelling of the marketed product(s). Placebo controlled trials will not be open to the notification scheme, nor will trials in which the marketed product has been modified, for example by over-encapsulation.

Following receipt of a valid notification submission, sponsors will receive an acknowledgement letter to say that the trial may go ahead after 14 days from receipt of the notification, if the MHRA has not raised any objections. This means that the acknowledgement letter will act as the authorisation.

If the MHRA raises an objection to the notification, the submission is treated as a standard request for authorisation and an assessment is carried out in the usual way with a time line of 30 days from the receipt of the original notification.

A risk assessment based on the potential risks associated with the use of the investigational medicinal product (IMP) should be made by the sponsor. Background documentation on how to do this is provided on the web site in the new section on the Notification Scheme.

This is the first part of the Medical Research Council (MRC) / Department of Health (DH) / MHRA Joint Project on Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products.

The second part of the project will provide guidance on risk-proportionate approaches to the management and monitoring of clinical trials. This will be available following the completion of the currently on-going pilot phase.

Pete Gough, Partner, NSF-DBA Ltd.

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