Europe – EU agencies adopt workplan on AI in medicines regulation

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a workplan to facilitate the “responsible and beneficial” use of artificial intelligence (AI) in medicines regulation, while managing the technology’s risks. The workplan was developed by the agencies’ Big Data Steering Group and is set to govern AI activities through 2028.

“Artificial Intelligence (AI) systems are gradually becoming a dominant tool supporting intellectual work and powering automation across all walks of life,” states the workplan. “The European medicines regulatory network’s (EMRN) vision on AI is for a regulatory system harnessing the capabilities of AI for personal productivity, process automation and systems efficiency, increased insights into data and strengthened decision-support for the benefit of public and animal health.” The workplan approved by EMA’s Management Board at its December meeting…