Clinical trials of investigational medicinal products (CTIMPs)
As defined in the European Clinical Trials Directive 2001/20/EC, CTIMPs have been governed by UK law since 1st May 2004 by virtue of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031, amended 2006).
CTIMPs are defined as any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any Adverse Reactions (ARs) to an investigational product(s), and/or study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.
The item investigated could be a drug or food product and is called the IMP - the Investigational Medicinal Product (IMP). It is defined as:
“A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorised indication, or when used to gain further information about the authorized form. EU Directive 2001/20/EC Article 2 (d) It follows that medicinal products with a marketing authorization are IMPs when they are to be used as the test substance, reference substance or comparator in a clinical trial, provided the requirement(s) in the definition above are met.”
Studies involving non-CE marked medical devices or medical devices used outside of their CE marking carried out in the UK may be regulated as clinical investigations under the Medical Devices Regulations 2002 and require approval from the UK Competent Authority.