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Scientific innovation is rapidly changing how medicines are discovered, developed, and evaluated, generating increasingly complex data. Regulatory systems must adapt to these advances to ensure new medicines reach patients efficiently. Artificial intelligence (AI) presents significant opportunities to enhance regulatory capacity and streamline processes.
Artificial intelligence offers robust opportunities to enhance regulatory capacity, manage complex data, and improve the efficiency of regulatory processes. It is crucial for the innovative pharmaceutical industry that regulatory frameworks for these technologies evolve responsibly and ethically, maintaining trust and confidence in decision-making.
To prevent regulatory fragmentation and encourage shared learning and capacity building, greater alignment in principles, terminology, and strategies is essential as national regulatory authorities increasingly adopt AI-enabled approaches. This harmonization will support more efficient global development and regulatory pathways for medicinal products.
Regulatory authorities are exploring the use of AI in various areas, including internal operations, regulatory documentation, medicinal product review and scientific assessment, inspections, and other regulatory procedures. These applications have the potential to significantly support and inform regulatory decisions across the pharmaceutical lifecycle.
This paper provides insights from the innovative pharmaceutical industry on how regulatory authorities can utilize AI in activities related to medicinal products. It highlights key considerations, opportunities, and challenges for implementation, aiming to foster constructive dialogue among regulators, industry, and other relevant stakeholders.