Frequently asked questions

What are the UK regulations?

The Medicines for Human Use (Clinical Trials) Regulations 2004, is the Statutory Instrument that transposed the EU Clinical trials Directive (PDF, 152 KB) into UK law in May 2004. Each member state will have their own regulations or administrative provisions transposing the Directive into national law.

Are all UK trials covered by the regulations?

The Directive (PDF, 152 KB) and the implementing UK Regulations; cover only investigations/studies which are undertaken to ascertain the efficacy or safety of a medicine in human subjects. Non-interventional trials are excluded from the Regulations. To classify a trial as non-interventional, it must meet all of the following criteria:

  • are studies involving products with a marketing authorisation that are prescribed in the usual manner and used in accordance with the authorisation;
  • when the patient is assigned to a therapeutic strategy within current practice and not according to a protocol;
  • the diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy;
  • and epidemiological methods are used to analyse the data.

(See the Regulations for a precise definition.)

If a study is not for the purpose of ascertaining the effects of or reactions to a product and the product is simply being used as an aid or tool in the study, it is not a clinical trial covered by the Regulations. For example, in the case of the study of blood flow involving the infusion of vasoactive substances, if the purpose of the study is to monitor the effects of a particular substance to see if it is effective in achieving a particular physiological effect, then it is not a clinical trial. If the infusion is for the purpose of modifying the rate of flow for a therapeutic indication such as claudication, it would be deemed a trial under the Directive as the purpose of the study is to establish the efficacy of a particular medicine.

The MHRA have released an algorithm (PDF, 25 KB) to help clarify which trials fall under the scope of the Regulations.

Do the regulations apply to all products?

Not all unlicensed chemical entities administered to patients or healthy volunteers are considered as investigational medicinal products. The Regulations apply only to those that are medicinal products and are to be tested or used as a reference in a clinical trial.

Are medicines used in trials monitored under the directive?

The Regulations require that medicines to be used in a trial be manufactured to standards of Good Manufacturing Practice (GMP) to prevent participants being exposed to unsafe medicines. During the trial the sponsor and investigator monitor participants’ safety and notify MHRA; and the ethics committee; of any unexpected serious adverse reactions to the medicines used in the trial so that the effects of unanticipated risks are minimised.

Are fees charged under the regulations?

The Directive (PDF, 152 KB) required the UK to subject all clinical trials to an authorisation procedure and did not distinguish between commercial or non-commercial trials. The MHRA charges fees to recover the administration costs of assessment, authorisation, issuing of manufacturers’ licences and inspection.

What are the transitional arrangements for a trial that began before the arrangements were introduced in 2004?

The MHRA agreed transitional arrangements for clinical trial authorisations. They also agreed transitional arrangements for manufacturers to apply for licences to manufacture IMPs. Nearly all currently authorised clinical trials were converted to “Clinical Trial Authorisations” without any further application. For a few trials, more information may be required if they are with unlicensed products on which there is insufficient data to meet the new requirements. The MHRA recruited additional staff to handle the increased number of applications.

I have heard that the rules might be changing - when will this happen?

The Clinical Trials Toolkit describes the requirements for Clinical Trials of Investigational Medicinal Products (CTIMPs) brought about by the introduction of the European Commission Directive 2001/20/EC.  A proposal to repeal Directive 2001/20/EC and replace it with a European Regulation was published in 2012.  The precise content and format of the new regulations is still being negotiated.   The Toolkit will publish news and provide information on developments as the situation emerges, and the routemap and content will be updated and amended to reflect the legal position in due course.