EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices

The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices.

Regulators say the rapid advances in pharmacogenomics over the past decade have made the existing guidance outdated, prompting the update.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency announced that the government has adopted a set of recommendations on the use of artificial intelligence in medical devices, developed by an independent group of NHS doctors.

The MHRA also said it is launching the third phase of its AI Airlock, a regulatory sandbox designed to test and evaluate new AI-based products.