Research with a medicinal product

The Medical Research Involving Human Subjects Act (WMO) offers the following definition of research with a medicinal product:

‘an investigation intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of any investigational medicinal product, and/or to identify adverse reactions to any investigational medicinal product and/or to study the absorption, distribution, metabolism and excretion of any investigational medicinal product with the object of ascertaining its safety and/or efficacy' (unofficial translation)

In short: if your research has the aim of studying the mechanism of the effect, safety or effectiveness of a medicinal product, then it is research with a medicinal product. Your research must then undergo the extra, marginal review by the competent authority.

A clear definition of the term research with a medicinal product is not always easy to make. Discussion is currently ongoing on this. A handy tool is the Algorithm on the last pages of the Q&A-form part of CT Directive 2001/20/EC.

An overview of all European legislation for research with a medicinal product (including the ICH guidelines for Good Clinical Practice) is available in Eudralex Volume 10.