The Role Of Digitalization And Artificial Intelligence In Streamlining Pharmaceutical Regulatory Affairs: Opportunities And Challenges

Abstract

Artificial intelligence (AI) is revolutionizing the pharmaceutical and healthcare industries, including the critical areas of regulatory affairs. AI technologies such as machine learning (ML), deep learning (DL), and natural language processing (NLP) are being increasingly employed to streamline regulatory processes, enhance decision-making, and improve operational efficiency. In regulatory affairs (RA), AI reduces the time required for marketing authorization applications, facilitates faster regulatory approvals, and helps pharmaceutical products reach the market more efficiently. This paper examines the integration of AI in pharmaceutical regulatory affairs, highlighting its potential to automate routine tasks, minimize human error, and accelerate the approval process. While AI-driven platforms offer considerable promise, challenges such as bias in AI models, data security, and the need for clear regulatory guidelines persist. By addressing these issues, AI can support the global harmonization of regulatory standards, shorten the drug development lifecycle, and ultimately provide patients with faster access to innovative therapies. This study also explores how AI can reshape clinical trials, enhancing recruitment, retention, and patient monitoring, while reducing trial timelines and costs. These advancements make AI a transformative tool for the pharmaceutical industry’s regulatory landscape, though careful consideration of ethical and operational challenges remains crucial.