20/21 November 2019
GMP News No. 823
24 October 2006
Eudralex Volume 10 Summarises Requirements on Clinical Trials
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:
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On the same day, the "Draft guidance on specific modalities for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for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
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.