EMA publishes Draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

In February the EMA published the draft of a guideline related to the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials. This draft is open for consultation until end of August 2010.

For clinical trials in the European Union, it is necessary to submit applications to conduct clinical trial to the competent authorities for approval. it has to be done separately in each number state in which the clinical trial will take place.

Together with available guidelines on the quality of biological / biotechnological medicinal products like the guideline for virus safety (EMEA/CHMP/BWP/398498/05) or the guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products (EMEA/CHMP/SWP/28367/07, current version), this guideline aims to ensure harmonised requirements for the documentation to be submitted throughout the European Community.

It stays abreast to the fact that there are clear differences between the requirements for a dossier for a clinical trial and a marketing authorisation dossier. Whilst the latter has to ensure a consistent, state-of-the-art quality of a product for widespread use in patients, information to be provided for an IMP should mainly focus on those quality attributes related to safety aspects.

This guideline addresses the documentation on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans. It includes the requirements for IMPs to be tested in phase I, phase II and phase III studies. The requirements defined in this guideline apply to recombinant proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates). These proteins and polypeptides can be highly purified and characterised using an appropriate set of analytical procedures. The principles that are outlined in the document may also apply to other biological products.

The whole document can be found here.

Please have attention to the ECA Education Course  "Virus and TSE Safety made simple" in Munich, Germany, from 22-23 September 2010. This course will give a deep insight in virus safety aspects of biological based medicinal products.

Axel Schroeder
On behalf of the European Compliance Academy (ECA)

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