ARTIFICIAL INTELLIGANCE DRIVEN TRANSFORMATION IN REGULATORY AFFAIRS AS PER CDSCO in (India) IN COMPARISION WITH HEALTH CANADA (Canada)

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1. [1]AI is a broad field of computer science focused on creating systems that can perform tasks that normally require human intelligence and Examples: Speech recognition (e.g., Siri), image recognition, decision-making, language translation, autonomous vehicles. Drug discovery & non-clinical development- Target identification, in-silico ADMET prediction, candidate selection. Regulatory questions: validation of in-silico models, reproducibility, transparency of inputs. Clinical development and trial design- AI for patient selection, synthetic control arms, adaptive trial designs, predictive biomarkers, and decentralized trials. Automatically screen and validate regulatory submissions. Detect incomplete application data. Overall, Health Canada’s approach highlights the importance of responsible AI adoption, providing valuable guidance for strengthening regulatory efficiency, transparency, and public trust13. Lastly, we are grateful to all those people who have been instrumental in the completion of this article. Central Drugs Standard Control Organisation (CDSCO). Overview of CDSCO's regulatory framework [Internet]. Available from: https://cdsco.gov.in [cited 2026 Sep 17]. Health Canada. Overview of Health Canada regulatory framework [Internet]. [cited 2026 Aug 19]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/precision-regulating-authorities-under-food-drugs-act.html AI clinical applications in Health Canada (CADTH) [Internet]. [cited 2026 Aug 22]. Available from: https://www.cda-amc.ca/overview-clinical-applications-artificial-intelligence Health Canada presentation on regulatory challenges of AI products [Internet]. 2023 Sep 27. Available from: https://www.cadth.ca/sites/default/files/symp-2019/presentations/april15-2019/A3-presentation-tdumouchel.pdf Canadian Foundation for Healthcare Improvement. Artificial intelligence (AI) in healthcare [Internet]. [cited 2026 Aug 22]. Available from: https://www.cfhi-fcass.ca/opportunities/webinars/artificial-intelligence-in-healthcare 7 ways AI is impacting regulatory bodies across the globe [Internet]. Freyr Solutions; [cited 2026 Sep 17]. Available from: https://www.freyrsolutions.com/blog/7-ways-ai-is-impacting-regulatory-bodies-across-the-globe Health Canada organization structure [Internet]. [cited 2026 Aug 19]. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1754-7121.1975.tb01937.x Central Drugs Standard Control Organisation. Regulatory workflow of CDSCO [Internet]. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf [cited 2026 Sep 18].

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