Drug regulation is undoubtedly a crucial aspect of healthcare, especially as Artificial Intelligence (AI) continues to reshape the industry. With AI revolutionizing various facets of medicine, its role in regulatory processes is becoming increasingly significant.

This paper explores how AI-driven technologies are transforming drug approval systems, pharmacovigilance, and compliance monitoring. By leveraging machine learning, natural language processing, and big data analytics, AI empowers regulatory agencies to process vast amounts of information more efficiently, detect potential risks earlier, and enhance overall public health outcomes.

However, alongside its benefits, the paper also addresses key concerns such as data privacy, algorithmic transparency, and ethical considerations in AI-driven decision-making. It underscores the need for adaptive regulatory frameworks that can keep pace with the rapid advancements in AI technology.

Ultimately, the paper presents a compelling argument for AI’s role in modernizing drug regulation while also highlighting critical challenges in governance and accountability. While AI has the potential to accelerate and optimize regulatory processes, ensuring transparency and ethical oversight remains paramount. A collaborative effort among AI developers, regulatory agencies, and healthcare professionals will be essential in building a regulatory system that is both efficient and trustworthy.