The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly established ten guiding principles for the use of artificial intelligence (AI) in the entire medicine lifecycle. These principles apply from early drug research through clinical trials, manufacturing, and safety monitoring.
The principles aim to ensure that AI tools are managed expertly to mitigate risks. They provide a foundation for future regulatory guidance and support international collaboration among regulators and medicine developers. These principles are part of ongoing efforts by both agencies to promote the safe, effective, and responsible use of AI in developing medicines.
Source | https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
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