68 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 REGULATORY baseline, closer scrutiny of data integrity and far greater pressure to remediate. Western partners are already demanding evidence of solvent recovery, impurity controls and supplier oversight before signing supply agreements. This evolving landscape across Asia is marked by an emphasis on acceleration and accountability, with regulators offering expedited approval for strategic products while insisting on stronger oversight of manufacturing practices and data integrity. Multinationals adjusting to this balance must weigh the attraction of local incentives against the operational risks of weak compliance, recognising that reputational capital increasingly depends on demonstrable quality. ICH - Progress with persistent gaps At the multilateral level the International Council for Harmonisation (ICH) is steadily extending the global quality framework. ICH Q13 on continuous manufacturing has now reached Step 5 adoption in Europe, with the Council emphasising that the new analytical guidelines Q2(R2) and Q14 “are intended to complement ICH Q8 to Q12 Guidelines, as well as ICH Q13 for Continuous Manufacturing.” 9 In May 2025 the Assembly confirmed a further expansion of its agenda, stating that it had “adopted four new topics for harmonisation,” 10 perhaps an indication of the workload ahead. Companies that structure their submissions to reflect ICH guidance are already finding that dossiers move more easily across jurisdictions and face fewer surprises in review. Real-time monitoring principles in Q13, analytical packages shaped by Q2(R2) and Q14, and quality systems designed with Q10 at their core are easing frictions that once slowed approvals. But divergence is far from eliminated. European regulators emphasise the need for AI transparency, their US counterparts lean on risk-based evaluation, and Asian agencies vary widely in the intensity of oversight. As the ICH Assembly itself conceded, harmonisation “remains a work in progress,” and national interpretation will continue to determine outcomes. Strategy - What it means for pharma The next phase of compliance will reward companies that treat regulation as strategy as much as science itself. Frost & Sullivan projects the pharmaceutical sector to expand at around 7% annually through 2030 yet stresses that sustaining this trajectory depends on operational innovation rather than pipeline volume.11 The firm also notes that ESG has climbed into the top tier of life-sciences CEOs’ strategic priorities, highlighting how regulation and reputation are converging. 12 Artificial intelligence illustrates the shift most clearly. The FDA has reported “a significant increase in the number of drug application submissions using AI components,”5 while the EMA insists on a “human-centric approach.” IQVIA expects AI to play an expanding role in pharmacovigilance and lifecycle management this year, putting compliance systems under pressure to match innovation. 13 Quality frameworks and sustainability complete the picture. ICH Q13 on continuous manufacturing establishes new global expectations for real-time control and lifecycle management, 14 while Europe’s pharmaceutical reform aims to “make medicines more environmentally sustainable.” 15 Companies that anticipate these priorities by embedding explainable AI, designing for continuous manufacturing, and exceeding minimum environmental standards, will find themselves better positioned to convert compliance into competitive advantage.
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