Eudralex Volume 10 Updated

GMP News
13 February 2008

Eudralex Volume 10 Updated

Eudralex Volume 10 has been amended by recommendations on various ethical aspects of clinical trials performed with children. These recommendations shall contribute to the protection of children who are the subject of clinical trials. Furthermore, the recommendations are intended to facilitate a harmonised application of rules on clinical trials across the EU and thereby facilitate the conduct of clinical trials in the EU. These recommendations are published in Chapter V: Additional Information.
A summary of the consultation response can be found here.
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. Here, Chapter 6 "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:

Hear essential aspects about the organisation and management of clinical trials, IMP distribution and things to consider during the study in the ECA Education Course

During this course, the important interfaces between GMP and GCP will be elaborated.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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