Positron Emission Tomography (PET)
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:
- MHRA - How we regulate
- MHRA: PET trials - General information
- MHRA: PET trials - Additional information
- European Medicines Agency - What we do
- The Administration of Radioactive Substances Advisory Committee (ARSAC)
- UK Radiopharmacy Group
- MRC - Regulatory Support Centre
- European Pharmacopoeia Online
- European Directorate for the Quality of Medicines & Healthcare (EDQM)
- MHRA Orange Guide
A list of FAQs can be found here.
A number of study scenarios are available 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.
