Before a medicine can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient.
This section contains information on every aspect of the clinical trials process.
About clinical trials for medicines
Introduction to Clinical trials including an overview of the process involved in obtaining a clinical trial authorisation.
Is a clinical trial authorisation required?
Details of when a clinical trial authorisation (CTA) is required.
Risk adapted approaches to management of clinical trials
A risk proportionate approach to the initiation, management and monitoring of certain clinical trials is possible. This section provides further information, including details on how to submit via the clinical trial notification scheme.
Go to the section risk adapted approaches to management of clinical trials
Managing your clinical trial authorisation
Information about managing a clinical trial authorisation.
Special interest groups
Information for special interest groups conducting clinical trials, including academic and PET trials.
Legislation
Information on legislation relating to clinical trials in UK and Europe.
Contacting us
For general enquiries: clintrialhelpline@mhra.gsi.gov.uk or 020 3080 6456 (Monday - Friday 08:30-16:30)
News and hot topics
The latest news and information related to clinical trials.
Applying to conduct a clinical trial
Information for each stage of conducting a clinical trial.
Safety reporting - SUSARS and ASRS
How to report safety problems - suspected unexpected serious adverse reaction (SUSAR) and Annual safety reports (ASRs).
Assessment performance
Details of our performance assessing applications.
Good Clinical Practice
The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation.
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification.
