Clinical trials for medicines

Good Clinical Practice Guide banner


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

Woman in lab - Small
Introduction to Clinical trials including an overview of the process involved in obtaining a clinical trial authorisation.
The unwanted display of the text is removed here...dont delete this

Is a clinical trial authorisation required?

Clinical trials - nurse counting tablets small image
Details of when a clinical trial authorisation (CTA) is required.
The unwanted display of the text is removed here...dont delete this

Risk adapted approaches to management of clinical trials

CDs
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.
The unwanted display of the text is removed here...dont delete this

Managing your clinical trial authorisation

Clinical trials - Female scientist with molecule model splash
Information about managing a clinical trial authorisation.
The unwanted display of the text is removed here...dont delete this

Special interest groups

Academic conducting tests in a lab (small)
Information for special interest groups conducting clinical trials, including academic and PET trials.
The unwanted display of the text is removed here...dont delete this

Legislation

Law books
Information on legislation relating to clinical trials in UK and Europe.
The unwanted display of the text is removed here...dont delete this

MHRA Innovation Office

Scientist working with nanotechnology
The MHRA’s Innovation Office has been set up to help companies, SMEs, academics and individuals, who have developed a novel medicine or device, or a distinctly novel approach to the development or manufacture of a product, in their regulation.
The unwanted display of the text is removed here...dont delete this

Contacting us

Telephone

For general enquiries: clintrialhelpline@mhra.gsi.gov.uk or 020 3080 6456 (Monday - Friday 08:30-16:30).

For status and tracking enquiries: ris.ct@mhra.gsi.gov.uk or 020 3080 7400.

The unwanted display of the text is removed here...dont delete this

News and hot topics

Man reading a newspaper
The latest news and information related to clinical trials.

Applying to conduct a clinical trial

Applying for clinical trial authorisation - splash page
Information for each stage of conducting a clinical trial.

Safety reporting - SUSARS and ASRS

Nurse reporting a safety problem on a computer - home
How to report safety problems - suspected unexpected serious adverse reaction (SUSAR) and Annual safety reports (ASRs).

Assessment performance

Amendments - splash page
Details of our performance assessing applications.

FAQs

Raised hand
Frequently asked questions about clinical trials applications.

Good Clinical Practice

UK clinical trial authorisation assessment performance - splash page
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

Close up of petri dishes GMP - small
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.
Page last modified: 12 September 2013