Eudralex Volume 10 has been amended with guidance documents containing the
common provisions on the conduct of Good Clinical Practice (GCP) inspections by
the competent authorities of the Member States. On the basis of input from the
GCP Inspectors Working Group and after consultation of the Member States, GCP
guidance is now published in Chapter IV of the Eudralex Volume 10.
Eudralex Volume 10 Clinical Trials - Notice to applicants (this is the official
title) is based on the corresponding Directives (2001/20/EC, 2005/28/EC,
2003/94/EC) and summarises existing GCP and GMP guidelines/guidances. Apart from
that, the document also includes recommendations in the form of recommendation
documents. Chapter IV "Recommendations on Inspections" is interesting, since it
reflects the EC's expectations of the inspectors in its member states. Although
mainly directed at GCP inspectorates, the document is also of interest to all
those who are looking for pointers and recommendations on how to train their
own, company-employed auditors.
It also includes the Guidance and other medicinal products used in clinical
trials. This document intends to clarify and provide additional guidance on the
definition of investigational medicinal products and to provide specific
guidance about the use of non-investigational medicinal products, in accordance
with the applicable EU legislation and lays down definitions agreed on by the
European Commission and the member states.
Eudralex Volume 10 Clinical Trials can be found on the following web page:
On behalf of the European Compliance Academy (ECA)