New Guidance Published in Eudralex Volume 10 - Clinical Trials

GMP News
18 July 2007

New Guidance Published in Eudralex Volume 10 – Clinical Trials

The Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials has been added to Chapter V (Additional Information of EUDRALEX Volume 10 - Clinical Trials.

As the European Commission points out in the document's introduction, it "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.

The Guidance complements the "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial"1 and the "Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use".

Besides clarification on how an IMP is defined, the document also gives general guidance on other medicinal products used in clinical trials like for example concomitant or rescue/escape medication for preventive, diagnostic or therapeutic reasons and/or to ensure that adequate medical care is provided. Guidance is also given on medicinal products which are normally used in clinical trials as non-investigational medicinal products (NIMPs).

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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