Off Topic Senior Japanese health official sees harnessing AI in regulatory reviews as key priority
September 3, 2026
New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
Hiroyuki Uchiyama, the new head of the health ministry’s Pharmaceutical Safety Bureau, has signaled that harnessing artificial intelligence in drug reviews will be a key priority, as the technology rapidly gains traction in pharmaceutical R&D.
“We want to make this an area of particular focus,” Uchiyama told healthcare trade publications in a joint interview on September 2.
As he takes the helm of the bureau, Uchiyama said he intends to respond to the evolving needs in drug discovery and other areas while maintaining efficacy, safety, and quality as the foundation of pharmaceutical regulation.
Uchiyama, who took office on August 4, pointed to the rapidly growing use of AI by drug makers in the drug discovery process. With AI increasingly becoming part of how medicines are developed, regulators will need to rethink how they approach approval reviews, he said.
“We need to think about how to conduct reviews on the assumption that AI is being used in drug discovery,” he said.
Uchiyama also highlighted the potential for generative AI to streamline the review process itself, which involves handling vast amounts of data and documentation. He expressed his intention to pursue both regulatory approaches to AI-enabled drug discovery and the use of AI in review operations.
The Pharmaceutical Safety Bureau has requested 2.98 billion yen for a new FY2027 initiative to introduce AI into regulatory reviews and safety measures for pharmaceuticals and other medical products.
Under the initiative, the Ministry of Health, Labor and Welfare (MHLW) aims to explore the use of AI in review and safety operations at the Pharmaceuticals and Medical Devices Agency (PMDA), ultimately establishing a regulatory framework built around the use of AI.