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EU Clinical Trials

About

The Medicines for Human Use Trials (Clinical trials) Regulations 2004, came into force on 1 May 2004. In the UK, the regulatory agency for these regulations is called the MHRA: Medicines and Healthcare products Regulatory agency, which is an executive agency for the DoH with trading fund status. The MHRA is also referred to as the Competent Authority (CA). The MHRA is the only authority in the UK who can authorise clinical trials which fall under this EU directive. The EU clinical trials directive regulates the conduct of clinical trials involving medicines for human use. The aims of the directive are:

To protect the rights, safety and well being of trial participants

To simplify and harmonise the administrative provisions governing clinical trials

To establish a transparent procedure that will harmonise trial conduct in the EU and ensure the credibility of results.

Summary of procedures for interventional clinical trials for medicinal products in humans

Step 1: Does your trial fall under the regulations?

Step 2: Apply for CTA and ethics opinion as well as R&D approval

Does the trial fall under the EU Directive legislation?

Please refer to the Clinical Trials algorithm to establish whether your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP) which falls under the EU directive.

A significant amount of detailed information is also available on the Clinical Trials Toolkit website that will help you decide whether your clinical trial falls under the legislation:

If your trial will fall under the new legislation, you will need to apply for a clinical trial approval. If you are still not sure, contact Medicines and Healthcare products Regulatory Agency (MHRA)

or contact the Clinical Trials Manager:

If you establish that your research does fall under the EU Clinical Directive and you wish the Trust to be the sponsor (or joint sponsor with the University), you should arrange a meeting with the R&D Clinical Trials Manager bringing with you a draft protocol.

You will not be able to submit to the MHRA without the sponsoring organisations authorisation.