66 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 REGULATORY Few forces influence the pharmaceutical industry as powerfully or as quietly as regulation. What was long treated as a supporting framework is now a key consideration, redefining how pharma innovates and competes on the global stage. Regionally, priorities are diverging with Europe testing the boundaries of AI in drug development and Washington firming its grip on digital health. Further afield, Beijing and New Delhi are negotiating the delicate balance between speed and scrutiny. Despite these efforts, global agreement through the International Council for Harmonisation (ICH) remains unsettled with new quality standards adopted across the US, EU and Asia. For multinationals, the regulatory frontier is where strategic choices are made, whether to double down on AI explainability, shift production closer to patients, or price in the ESG footprint of their medicines. Europe - EMA on AI, biologics, and sustainability The European Medicines Agency (EMA) has moved decisively to define its position on AI, framing its guidance using a “human-centric approach [that] should guide all development and deployment of AI and machine learning (ML),” in a recent reflection paper.1 That position carries operational weight in that companies must now demonstrate model provenance, risk management and performance from discovery through post-authorisation. EMA’s 2024 annual report notes that the Agency has been “utilising artificial intelligence for the benefit of patients and public health” among its priorities. The same report describes EMA’s internal use of AI (e.g. for knowledge mining) as part of efforts to modernise processes. 2 Brussels is also quietly rewriting the rulebook on biologics. As recently as April 2025 the EMA said it was “exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards.” The shift in tone suggests a greater reliance on advanced analytics and human pharmacokinetics in certain cases, reflecting a decade of accumulated data, and could in some cases reduce the need for comparative efficacy trials. For industry, particularly originators and biosimilar sponsors, there must be a rethink as to where to allocate capital; extensive head-to-head studies, streamlined evidence packages or market-timing strategies across jurisdictions. At the same time, Europe is embedding environmental sustainability into its pharmaceutical framework with reform looking to “make medicines more
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