Directive 2001/20/EC - "the Clinical Trials Directive" - was adopted in April 2001 with an implementation date of May 2004. In the two years since the implementation date there has been evident a divergence between EU member states on the interpretation of various elements of the Directive.
One of the areas of most concern to industry has been the apparent variation between member states of the definition of Investigational Medicinal Product.
In an effort to clarify the situation, DG Enterprise and Industry of the European Commission issued in July a consultation on a proposal for guidance on the "Definition of Investigational Medicinal Products (IMP) and Definition of Non Investigational Medicinal Product (NIMPs).
This is available at http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/07_2006/def_imp_2006_07_27.pdf
The Commission advises that this guidance is intended to reflect a common understanding between member states and DG Enterprise and Industry, with the view to facilitating the conduct of multi-centre trials.
The development of guidance is to be welcomed as the variety of interpretations of what is regarded as an IMP or as a NIMP is confusing and frustrating to industry as it seeks to facilitate in the most efficient and expeditious way multi-site clinical trials throughout the EU. However, it is essential that once the guidance has been finalised, the Commission ensures its uniform application throughout member states. Similar guidance in other areas where there is significant divergence would also be helpful.
The consultation period lasts until 1 October and ABPI is collating the views of members and preparing an Association response to the proposed guidance and this column will return to the issue as its implementation unfolds.