CHMP adopts new Guideline on Good Pharmacogenomic Practice

The new guideline adopted by the CHMP will become effective on 1st September 2018

Genomic data have become important in the evaluation of efficacy and safety of medicinal products for regulatory approval. Genomic information in the product information (PI) influences patient treatment decisions. Therefore, use of genomic biomarkers in drug development, should, in order to be of value, follow certain principles which are outlined in this guideline.

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Some methodological issues with respect to genomic clinical study design highlighted in this guidance is complementary to the what is described in the Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection (see section 3).

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