EU Advances AI Integration for Enhanced Medical Product Regulation Through Joint HMA-EMA BDSG

The European Union (EU) has been actively exploring ways to leverage Artificial Intelligence (AI) to enhance regulatory processes, improve efficiency, and ensure the safety and efficacy of medical products. The AI workplan has been prepared under the joint HMA-EMA Big Data Steering Group (BDSG). The EMA and other regulatory bodies within the EU have been involved in initiatives and discussions related to the integration of AI in the regulatory landscape.