New Amendments to Eudralex Volume 10

GMP News
18 June 2008
 

New Amendments to Eudralex Volume 10

  
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:
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol10_en.htm#chap_iv

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

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