The definition of Investigational Medicinal Product (IMP) and the use of Auxiliary Medicinal Product (AMP) are the subject of a recent consultative document from the European Commission’s expert group on clinical trials for the implementation of regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.
The consultative document was published on the 1 June 2016 and seeks to clarify the definition of an IMP and provide guidance on the use of AMPs which were previously known as Non-Investigational Medicinal Products NIMPs. This is being done to align with the new clinical trials regulations and the latest (scientific) insights.
IMPAn IMP is defined by the Regulation (EU) No 536/2014 Article 2 (5) defines an IMP as “a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial”. It follows on from this definition that medicinal products already with a marketing authorisation are IMPs too when they are to be used as the test product, reference product or placebo in a clinical trial.
An AMP is defined as “a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product”. In other words an authorised medicinal product which is not an IMP. The document does have some useful examples and classes AMPs into, Rescue Medication (hazard recovery), Challenge Agents (designed to produce a physiological response), Products used to assess end-points in the clinical trial (e.g. radiopharmaceutical diagnostics) and background treatment (pain medication etc.). Very much the supporting movie to the main feature.
One way to visualise this is to consider the origin of the word from Latin “auxillia” which means helps. In the days of ancient Rome the Legions were assisted by the Auxiliaries, soldiers, recruited from non-Roman tribes. Their name means ‘helpers’, and they assisted the Roman legionary troops by providing extra manpower and specialised fighting techniques.