Automatic extraction of SmPC document for IDMP data model construction using foundation LLM and RAG: a preliminary experiment for pharmaceutical regulatory affairs

Our findings demonstrate that the proposed LLM-RAG approach enables accurate and scalable extraction of structured data from SmPCs. This supports the digital transformation of regulatory processes by promoting standardization, interoperability, and harmonization. If implemented effectively, the method could help pharmaceutical companies improve regulatory compliance, streamline submissions, and improve data consistency.