AI Regulation: EU Network Announces Four-Year Action Plan

Multiple guidance documents, a regulatory sandbox, and the creation of an “observatory” to monitor the emergence of new technologies are some of the actions being considered by the European medicines regulatory network under its AI regulatory system workplan.

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The European medicines regulatory network – the group comprising the European Medicines Agency, the European Commission, and member states’ national competent authorities – has revealed a multi-annual workplan that will run until 2028 and, it hopes, lead to the creation of a regulatory system equipped to deal with the challenges and risks of artificial intelligence.

“There is a vision from the European medicines regulatory network,” said Luis Pinheiro, a senior epidemiology expert at the EMA,...

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