Dr. Peter Gough delivers a comprehensive regulatory update focused on two global priorities shaping today’s pharmaceutical landscape: artificial intelligence (AI) and drug shortages. Both areas are evolving rapidly, and Dr. Gough provides much-needed clarity on where regulations currently stand across the EU, USA, and UK—and where they are headed next.
AI regulation: Potential, risk and the push for control
Dr. Gough begins by outlining the extraordinary promise of AI and machine learning, while acknowledging the concerns raised even by pioneers like Professor Geoffrey Hinton. The message is clear: without robust oversight, the technology’s risks could outpace its benefits.
He highlights the EU’s leadership, noting it is the only region to have enacted AI legislation to date—Regulation 2024/1689. With a multi-year, multi-phase implementation stretching to 2027, organisations must understand which rules apply and when. Complementary EMA/HMA principles for the use of large language models in regulatory submissions reinforce the need for safe data input, critical evaluation of outputs, and ongoing monitoring.
Dr. Gough reviews the EMA’s updated Reflection Paper on AI, which emphasises a human-centric approach and provides early considerations for AI across the product lifecycle. He also anticipates long-awaited revisions to Annex 11 and Chapter 4, driven by data integrity concerns and the rise of AI/ML technologies.
From the US perspective, he summarises multiple FDA discussion papers addressing AI in manufacturing, drug development, and cross-centre coordination. Key themes include governance, bias prevention, data quality, performance monitoring, and the need for industry leadership in defining appropriate controls.
His message: AI is here, it is accelerating, and industry must take the lead in shaping its safe and effective use.
Drug shortages: A global challenge with expanding regulatory expectations
Turning to drug shortages, Dr. Gough examines one of the most pressing patient-impacting issues worldwide—from HRT and EpiPen shortages to disruptions in oncology medicines.
He traces more than a decade of US regulatory attention sparked by the Ben Venue crisis, which led to multiple legislative actions, strengthened FDA visibility, and expectations for manufacturers to maintain shortage prevention and mitigation plans. Despite progress, shortages have begun to rise again, particularly in biologics.
In the EU, Dr. Gough explains how new legislation and Regulation 2022/123 have expanded the EMA’s role, culminating in the European Shortages Monitoring Platform (operational February 2025). He outlines the EU’s list of 300 critical medicines, new reporting obligations for MAHs, and HERA’s Critical Medicines Alliance, which is conducting deep dives into root causes and supply-chain vulnerabilities.
For the UK, the MHRA is taking a watch-and-learn approach—encouraging risk-based supply chain oversight, early communication, and dossier maintenance while monitoring EU outcomes before imposing formal requirements.
A shared responsibility
Dr. Gough concludes by reaffirming that neither AI governance nor shortage prevention can be solved by regulators alone. Industry must collaborate, lead with transparency and innovation, and keep patient protection at the forefront as these regulatory frameworks mature.
NSF block
Companies all over the world rely on NSF’s expert team of pharma biotech, medical device, IVD, and combination product experts to guide them through the maze of regulations and industry challenges. Our experts can tailor a solution to meet the specific needs of your company. Since 1944, NSF has helped companies deliver life-saving and life-changing medical products to their patients
