New Definition for Auxiliary Medicinal Products (AMPs)

The EU Commission has launched four public consultations on recommendations related to clinical trials:

  • Public consultation on "Risk proportionate approaches in clinical trials"
  • Public consultation on "Summary of Clinical Trial Results for Laypersons"
  • Public consultation on the revision of the "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))
  • Public consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors"

The public consultations are open from 1 June 2016 to 31 August 2016.

The eight page consultation document "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" intends to "clarify and provide additional guidance on the definition of IMPs and to provide recommendations about the use of auxiliary medicinal products (AMPs)".

It is outlined that medicinal products with a marketing authorisation are also considered to be IMPs, "when they are to be used as the test product, reference product or placebo in a clinical trial." But what are AMPs? So far, Regulation (EU) No 536/2014 Article 2 (8) defines an AMP as "a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product". These could be, for example:

  • Rescue medication
  • Challenge agents
  • Medicinal products used to assess end-points in the clinical trial
  • Medicinal products used for background treatment

This means that AMPs are medicinal products. But not all products used in clinical trials are medicinal products (for example certain challenge agents). As a consequence these products are not AMPs. A list of types of AMPs, with examples, is included in Annex 1 of the respective document.

Furthermore the document discusses the use of authorised AMPs and unauthorised AMPs and further requirements like documentation and adverse reactions.

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