Europe – EMA Subgroup Questions Use of NBs to Assess Companion Diagnostics

While discussing the use of genomics data in regulatory processes, a subgroup of the European Medicines Agency (EMA) also called for a reconsideration of the current system of using notified bodies (NBs) to assess companion diagnostic tests, according to a 69-page report released Wednesday.

The report on genomics data, including epigenetics and transcriptomics data, features recommendations from experts in Netherlands, Germany and Belgium on “how to optimise the future use of genomics (big) data in regulatory processes.”…