Breaking Down International Regulators’ Thoughts on AI and Real-World Evidence

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A newly published paper in Regulatory Toxicology and Pharmacology explores insights shared by an international group of regulators at the 2021 Global Summit on Regulatory Science. The group consisted of regulators from the US, the UK, India, Japan, Italy, Germany, Canada, Singapore, Brazil, and Switzerland. During the talks, speakers discussed ways to use artificial intelligence (AI) and real-world evidence (RWE) in safety assessments for food and drugs.

According to Jeff Craven, “The regulators noted that they see the potential for AI and RWD in food safety, pattern recognition, and foodborne outbreaks, which “primarily relies on a manual analysis of images, spectrometric data, genomic data, chemical compositions, and identification of contaminants,” the authors said. AI and machine learning (ML) have the potential to reduce review times and human variations in manual processes. In many ways, AI and RWD are already here, with agencies like the FDA and Canadian Food Inspection Agency incorporating AI and RWD methodologies into existing programs.”

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(Source: RAPS, April 18^th, 2023)