Dr. Peter Gough delivers a comprehensive regulatory update focused on two global priorities: artificial intelligence (AI) and drug shortages. Regarding AI regulation, the EU is the only region to have enacted AI legislation to date—Regulation 2024/1689—with multi-phase implementation stretching to 2027. Complementary EMA/HMA principles for large language models reinforce safe data input, critical evaluation, and ongoing monitoring. The EMA’s updated Reflection Paper emphasises a human-centric approach. Dr. Gough anticipates revisions to Annex 11 and Chapter 4 driven by data integrity and AI/ML technologies. US FDA discussion papers address AI in manufacturing, drug development, and cross-centre coordination, focusing on governance, bias prevention, data quality, and performance monitoring. On drug shortages, Dr. Gough traces more than a decade of US regulatory attention sparked by the Ben Venue crisis, leading to strengthened FDA visibility and manufacturer expectations for shortage prevention plans, though shortages have risen again, particularly in biologics. In the EU, Regulation 2022/123 expanded the EMA’s role, culminating in the European Shortages Monitoring Platform (operational February 2025), a list of 300 critical medicines, new reporting obligations for MAHs, and HERA’s Critical Medicines Alliance. For the UK, the MHRA is taking a watch-and-learn approach, encouraging risk-based supply chain oversight and early communication.