Since 2017, the main regulatory agencies —the FDA, EMA and AEMPS— have required that the Summary of Product Characteristics (SmPC) of medications include a dedicated Pharmacogenetics section, specifying the genes involved and recommending their assessment as part of Good Clinical Practice prior to prescribing.

In Spain, Order SND/606/2024 (BOE No. 147, 18 June) formalizes the incorporation of pharmacogenetic analysis into the Common Portfolio of Services of the National Health System. This framework establishes that pharmacogenetic testing must be carried out in patients who require certain medications, enabling clinicians to define the most appropriate therapeutic strategy, anticipate treatment response and minimize adverse effects.

The regulation also stipulates that healthcare centers must perform a pharmacogenetic study before prescribing 65 medications covered by the public pharmaceutical benefit system —a requirement that directly impacts clinical practice in both public and private healthcare settings.

Through internal and external training programs and personalized guidance, we are driving the development of a new generation of professionals capable of sequencing, interpreting, and integrating genetics into therapeutic decision-making.

Our comprehensive approach enables healthcare professionals to acquire the skills needed to identify genetic variations, interpret their clinical implications, and apply them effectively in real-world settings—enhancing safety, precision, and personalization in treatments.