67 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 REGULATORY environmentally sustainable,” 3 without compromising supply resilience. EMA guidelines already require disclosure of environmental risks, but the debate is moving beyond transparency. Policymakers are pressing companies to tackle wastewater, solvent recovery and take-back schemes. The ramifications for industry now class ESG as no longer an optional parallel track. It is becoming a regulatory expectation, with environmental performance influencing both approval and access. As Brussels sharpens its rulebook, compliance is shifting from a late-stage hurdle to an organising principle of drug development. Sponsors are being asked to weave explainability and governance into AI models from the outset, to revisit biosimilar portfolios under an analytical-first approach, and to place environmental performance at the centre of their regulatory story. The reforms endorsed by the European Parliament in 2024 underscore that innovation will be measured not only by scientific output but also by its contribution to secure supply and sustainable practice. United States - FDA on AI and manufacturing In Washington the FDA is making headway on setting AI parameters for drug development and modernising expectations for manufacturing quality. The Agency set out its intentions in January 2025 with draft guidance, which established a “risk-based credibility assessment framework” to help sponsors demonstrate that models are reliable in specific contexts. 4 The document makes clear that transparency, bias mitigation, data lineage and human oversight are no longer optional features but regulatory expectations. The FDA’s stance was reinforced by developments within the Center for Drug Evaluation and Research (CDER), which noted “a significant increase in the number of drug application submissions using AI components over the past few years.” 5 In response, the centre established an AI Council charged with coordinating external guidance and internal deployment signalling a future, where regulators probe not only AI model performance but also processes used to retrain and monitor them over time. On the manufacturing side, the agency is equally decisive with its former Commissioner Scott Gottlieb, framing continuous manufacturing (CM) as a strategic lever for domestic industry. “Continuous manufacturing utilizes technologies that offer clear benefits … more nimble monitoring and control … help reduce the likelihood of manufacturing failures,” 6 he stated. “Advanced manufacturing can improve products and processes, advance drug quality, address shortages of medicines, and speed time-to-market,” 7 echoed Janet Woodcock at the FDA’s Pharmaceutical Quality Symposium. The FDA has backed its rhetoric with resources, using its 21st Century Cures authority to fund research on continuous manufacturing and to publish guidance that eases the transition from batch to continuous processes. Viewed in combination with the agency’s work on AI, these initiatives reveal a regulator increasingly focused on the credibility of models and manufacturing systems rather than on scientific novelty alone. China speeds access as India tightens quality Beijing is continuing to wield regulation as an instrument of industrial policy, seeking to accelerate innovation while anchoring production at home. The NMPA’s June 2025 device-priority announcement was explicit in its focus on localising advanced technologies, but the same logic is visible in pharmaceuticals, where innovative medicines are gaining priority review, expanded accelerated pathways and proposals for regulatory data exclusivity. The trajectory points toward faster approvals for strategic categories, balanced by tougher obligations on post-market quality and surveillance. Meanwhile, India is moving in the opposite direction, leaning on enforcement to restore credibility after a series of high-profile incidents. The Central Drugs Standard Control Organisation (CDSCO) disclosed in mid-2024 that over 36% of the plants it inspected had been forced to shut for noncompliance, and it has since introduced monthly NSQ alerts that expose batch failures to regulators and customers abroad. 8 The practical effect is a tightening of GMP expectations across the board. For API producers and exporters this amounts to a higher GMP
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