Drug regulation: recent advancements (2026)

Interviewer: With us today is Dr. Assem El Baghdady, Senior Lecturer in Pharmaceutical Medicine at the Center for Pharmaceutical Medicine Research at King's College London. He's a fellow of the faculty of pharmaceutical medicine with over 20 years of experience in drug development, both in industry and academia. Dr. El Baghdady joins us to provide an overview of recent developments in drug regulation. Dr. Assem El Baghdady, thank you so much for joining us today. Dr. El Baghdady: It's my pleasure. Interviewer: We're seeing multiple drivers of regulatory changes, from the integration of real-world evidence and digital data to keeping pace with rapid scientific advances using AI and machine learning. Looking back at the past year or so, what would you consider to be the most important developments in drug regulation? Dr. El Baghdady: This is a difficult question, but I will try to choose the most important developments in drug regulation. One of the most important developments, for example, has been the shift towards more flexible and more adaptive regulation. Regulators are increasingly using tools and initiatives, for example, accelerated approvals, conditional approvals, reliance on real-world data, especially for serious diseases like cancer, of course, rare conditions, and let us not forget the unmet medical needs. Perhaps, another key development is the stronger emphasis on patient-centered regulation. Patient-reported outcome, quality of life measures, and patient input earlier in development, of course,