Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation

News and resources | Publications Position paper 4 March 2026 Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation Downloads Position paper Share Topics Regulatory convergence and reliance Artificial Intelligence (AI) and Machine Learning (ML) are rapidly transforming various sectors, and the pharmaceutical manufacturing industry is no exception. This paper explores how the pharmaceutical industry may use individual applications of AI in pharmaceutical manufacturing and control. It describes the evolving regulatory landscape and provides key considerations for national regulatory authorities (NRA) when reviewing regulatory submissions or inspecting manufacturing sites that use or describe AI technologies in their processes.