ICH Topic E16 Genomic Biomarkers Related to Drug Response - Deadline for Comments in September 2009

The use of biomarkers during drug discovery and development will be one way to get safer and more effective medicines. Furthermore, the use in post approval has the potential to guide dose selection and to enhance the benefit-risk profile of approved medicines.

With the "NOTE FOR GUIDANCE ON GENOMIC BIOMARKERS RELATED TO DRUG RESPONSE: CONTEXT, STRUCTURE AND FORMAT OF QUALIFICATION SUBMISSIONS" which is open for comments till September 2009, the European Medicines Agency (EMEA) will create a harmonised structure for the qualification of genomic biomarkers that will foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. This guideline is based on previous experiences with submissions containing genomic biomarker data in the various regions. Such submissions have been either stand alone biomarker qualification applications or a component of the medicinal product-related regulatory process. It describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15.

It is one additional step in the interesting field of biomarkers, pharmacogenomics and personalized medicines which becomes more and more important.

More information about the Note for Guidance can be found here.

Like every year, the "ECA Bio Production Forum" in Schaffhausen, Switzerland, from 29 September - 1 October will concentrate on the ongoing topics from development to marketing authorisation of biopharmaceuticals.

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

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