🔔📢The European Medicines Agency has published for public consultation: a Concept paper on the guideline revision on good pharmacogenomic practice.
Since its initial publication in 2018, the guideline on good pharmacogenomic practice has played a crucial role in shaping best practices, ensuring consistency, and providing a clear framework for regulators and stakeholders. As anticipated at the time of its implementation, the field of genomics has continued to evolve, driven by scientific advancements, technological innovations, and emerging regulatory considerations. To reflect these developments, it is essential to revise the guideline on good pharmacogenomic practice, incorporating new evidence, methodologies, and best practices.
In addition to incorporating new scientific knowledge, this revision aims to provide greater clarity on topics already covered, facilitating more precise and actionable guidance for regulators and stakeholders. The guideline revision seeks to provide regulators and stakeholders with an improved framework that supports the highest standards of practice while fostering innovation and progress.
This guideline revision will take into account feedback from experts, recent scientific discoveries, and lessons learnt from the application of the initial guideline. The revised document will aim to maintain its core objectives while integrating improvements that align with the latest advancements in the field.
Comments should be provided by 31 March 2026 using this EU survey.