Health Canada

ABSTRACT: Artificial Intelligence (AI) is emerging as a transformative technology in pharmaceutical regulatory affairs, enhancing efficiency, accuracy, and regulatory decision-making throughout the product lifecycle. Recent studies have demonstrated the application of AI and Machine Learning (ML) in regulatory intelligence, dossier preparation, document management, pharmacovigilance, signal detection, and compliance monitoring. Regulatory agencies worldwide are increasingly exploring AI-driven approaches to streamline regulatory submissions and improve review processes while maintaining safety, efficacy, and quality standards. This review aims to evaluate the role of AI in transforming regulatory affairs and to compare the adoption and implementation of AI-enabled regulatory practices by the Central Drugs Standard Control Organization (CDSCO), India, and Health Canada. The study examines current applications of AI in regulatory operations, including automated document review, adverse event monitoring, data analytics, and decision-support systems. Furthermore, it assesses the opportunities, challenges, and regulatory considerations associated with AI integration, such as data governance, transparency, validation, ethical concerns, and workforce readiness. The study concludes that AI has the potential to reshape the future of regulatory science by improving operational efficiency and regulatory effectiveness. Strategic adoption of AI technologies by regulatory authorities can contribute to faster access to safe and effective medicines while maintaining high regulatory standards4.

Cancer remains a major global health challenge, necessitating continuous innovation in oncology therapeutics. While randomized controlled trials (RCTs) are the traditional gold standard for evidence generation, they often lack applicability to diverse real-world populations. This has fuelled growing interest in incorporating Real-World Evidence (RWE), derived from Real-World Data (RWD), into regulatory decision-making processes, especially in oncology. This study aims to compare how RWE is integrated into oncology drug regulation by two key regulatory bodies, Health Canada and India’s Central Drugs Standard Control Organization (CDSCO), in order to identify lessons and opportunities that can support India's evolving regulatory framework. A qualitative comparative analysis was conducted using regulatory documents, guidance frameworks, and real-world case examples. Canada’s CanREValue initiative was explored in depth, alongside an assessment of India’s emerging digital health infrastructure and policy efforts. Health Canada has established a mature RWE framework supported by multi-stakeholder collaborations and pilot projects, facilitating dynamic regulatory decisions in oncology. In contrast, CDSCO is in the early stages of RWE adoption, with limited formal guidance. However, initiatives like the Ayushman Bharat Digital Mission (ABDM) and national health registries offer promising pathways. Canada’s regulatory progress offers valuable insights for India. Strengthening digital infrastructure, developing national RWE frameworks, and fostering collaboration could transform India’s oncology regulatory ecosystem. This study highlights the potential of RWE to improve evidence-driven decision-making and enhance access to cancer therapies.