Eudralex Volume 10 Summarises Requirements on Clinical Trials

GMP News No. 823

GMP News
24 October 2006

Eudralex Volume 10 Summarises Requirements on Clinical Trials

On 27 July 2006, the European Commission (DG Enterprise and Industry) published the first edition of Eudralex Volume 10.

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.

Another recommendation refers to the content and archiving of the "Trial Master File" in accordance with Directive 2005/28/EC.

The table of contents reads as follows:

  • Chapter I: Application and Application Form
  • Chapter II: Monitoring/ Clinical Safety (Monitoring and Pharmacovigilance)
  • Chapter III: Information on the quality of the Investigational Medicinal Product
  • Chapter IV: Recommendation on inspections
  • Chapter V: Additional Information
  • Chapter VI: Legislation

Volume 10 is constantly updated. On 28 July, the consulted suggestion for a guidance was published under the title Definition of Investigational Medicinal Products (IMPs) and Definition of Non-Investigational Medicinal Products (NIMPs). After being passed, this guidance is meant to become part of Chapter V and lay down definitions agreed on by the European Commission and the member states.

On the same day, the "Draft guidance on specific modalities for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice" was published.

Further details and the contact persons for possible comments can be found on the following web page:

One important requirement for IMP development and manufacturing is the Product Specification File. Lean more on how to implement and use this document at our Webinar on 5 December 2006.

The practices of IMP distribution are getting more and more in the focus of the industry and the authorities. Especially if there is a need for a cold chain. Learn more about the management of the cold chain at our Webinar on 22 January 2007.

Wolfgang Schmitt
On behalf of ECA

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