69 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 REGULATORY CPhI - Where the debate accelerates Regulation has always framed the pharmaceutical industry, but it has rarely been so central to its future. Artificial intelligence, continuous manufacturing, and environmental standards are not technical details on the margins but the architecture around which business models must now be built. The companies that thrive will be those that can turn compliance into differentiation, proving that their data are transparent, their systems resilient and their supply chains credible. At CPhI the conversation is shifting, from molecules and markets to governance and credibility. The winners of the next decade will be the firms that treat oversight not as a hurdle but as the playing field itself. References 1. https://www.ema.europa.eu/en/news/reflectionpaper-use-artificial-intelligence-lifecycle-medicines 2. https://www.ema.europa.eu/en/news/2024-annualreport-published 3. https://health.ec.europa.eu/medicinal-products/ legal-framework-governing-medicinal-productshuman-use-eu/reform-eu-pharmaceuticallegislation_en 4. https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/considerationsuse-artificial-intelligence-support-regulatorydecision-making-drug-and-biological 5. https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/artificial-intelligencedrug-development 6. https://www.fda.gov/news-events/fda-brief/ fda-brief-fda-supports-critical-research-spurinnovation-continuous-manufacturing-technologysupport 7. https://www.fda.gov/news-events/remarks-actingcommissioner-janet-woodcock-fda-pharmaceuticalquality-symposium-2021-innovations 8. https://www.reuters.com/business/healthcarepharmaceuticals/indian-regulator-says36-inspected-drug-making-units-had-beshut-2024-06-27/ 9. https://www.ich.org/page/quality-guidelines 10. https://ich.org/pressrelease/press-release-ichassembly-meeting-madrid-spain-may-2025 11. https://store.frost.com/global-pharmaceuticalindustry-outlook-2025.html 12. https://www.frost.com/growth-opportunity-news/ healthcare/precision-health/top-10-strategicimperatives-transforming-the-life-sciencesindustry-in-2025-tjstory-cim-sg/ 13. https://www.iqvia.com/blogs/2025/01/ai-trendsin-pharma-enhancing-drug-safety-and-regulatorycompliance-for-2025 14. https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/q13-continuousmanufacturing-drug-substances-and-drugproducts 15. https://health.ec.europa.eu/medicinal-products/ legal-framework-governing-medicinal-productshuman-use-eu/reform-eu-pharmaceuticallegislation_en WILL CHU Editorial team CHEMICALS KNOWLEDGE HUB
RkJQdWJsaXNoZXIy MjY2OTA4MA==