Since 2021, the Swedish Medical Products Agency has been building AI competence and capacity to meet regulatory needs and enable in-house intelligent automation. In this session we present both in house development projects and regularory activities within the EMA network.

To support harmonization of medicinal product information, we have used NLP models for sentence-level semantic clustering of the complete corpus of product information for centrally approved drugs in the EU.

To facilitate assessment of adverse event reports (AER) related to medicinal products, which have increased greatly in number during the covid pandemic, we have developed PhaVAI – a natural language processing model ensemble for AER severity classification.

 A core data science unit including a PhD candidate in applied AI is now a part of the Agency strategic planning for the future.