MHRA-PET Expert Panel on Regulatory Affairs

The MHRA-PET expert panel on regulatory affairs has been established to help researchers deal with the UK regulatory framework for medicines, specifically as applied to PET research. The overall aim is to help UK researchers understand and navigate through these regulatory requirements and thereby facilitate increased PET research.

PET Regulations in the UK

Regulations for Positron Emission Tomography (PET) studies are complex. It is often difficult for a researcher to know whether a particular PET study will be designated as a clinical trial or a mechanistic study. Clinical trials require a higher degree of regulation, as they require a Clinical Trials Authorisation (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA).

There are several webpages that provide useful PET- and regulatory-specific information:

A list of FAQs can be found here.

MHRA MRC NCRI Workshop, London, 10th September 2010

On 10th September 2010, the Medical Research Council (MRC), MHRA and the NCRI PET Research Network organised a workshop to guide the PET research community on regulatory aspects. The objectives were to provide information, reach a common understanding of MHRA requirements and clarify the application process for different categories of PET research. The workshop outlined the basis and principles of regulation in the area of PET imaging in general, and GMP facilities in particular, highlighting hazy areas that exist around the language and intent of protocols (to view the notes from the workshop please click here).

A number of study scenarios were discussed at the meeting, to help researchers understand how different regulatory routes may apply in different circumstances, as well as a decision tree to help researchers understand what documentation will be required for a particular study. These documents will be finalised and links provided after the meeting.