Investigational Medicinal Product [IMP]

An investigational medicinal product is an active ingredient or placebo that has been pharmaceutically formulated (prepared) for human use which is being tested, or used as a comparator, in a clinical trial.

Typically IMPs have not yet received marketing authorisation, however in some circumstances they may be products that have been authorised:

- when they have been made using a different formulation than that which is authorised (e.g. different dose),

- when the authorised product is to be used as the test substance or comparator in a clinical trial,

Glossary: Contract research organisation [CRO]
Glossary: Investigational Medicinal Product Dossier [IMPD]
Investigator’s Brochure
The Investigator's Brochure is a compilation of non-clinical and clinical data relevant to the study of the medicine in humans – it is the single most comprehensive document summarising the information on an investigational medicinal product.
Phase I Trials
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest, with the medicine that has been thoroughly and extensively tested in laboratory and animal studies before.
Phase II Trials
In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine treats the intended disease or condition.

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