Regulatory

Regulatory

The Center for Drug Evaluation and Research (CDER) of the US FDA has supported the use of pharmacogenomics for more than a decade by providing regulatory advice, renewing applications and developing policies and processes focused on genomics and individualized therapeutics.

In February 2020, the FDA published a list of 107 active drug constituents with “actional guidelines” recommending a pharmacogenomic test due to the frequent polymorphism in essential genes.

The European Medicines Agency supports the use of Personalized Medicine and requires pharmacogenomic data when new medicines are registered. However, their recommendations of pharmacogenomic testing related to drug treatment are reluctant.

For example, the prescription of fluorouracil for oncology patients is covered by an EMA recommendation: https://www.ema.europa.eu/en/medicines/human/referrals/fluorouracil-fluorouracil-related-substances-capecitabine-tegafur-flucytosine-containing-medicinal

In summary, the US and European authorities support the use of pharmacogenomic testing to some extent before prescribing particular medicines where genetic polymorphism plays an important role.

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