EMA to drug developers on AI: Carry out thorough risk assessments

The EMA is urg­ing drug de­vel­op­ers to ap­pro­pri­ate­ly as­sess the risk of us­ing ar­ti­fi­cial in­tel­li­gence or ma­chine learn­ing in the drug de­vel­op­ment process and to seek reg­u­la­to­ry in­ter­ac­tions ear­ly on, in a new re­flec­tion pa­per ad­dress­ing the grow­ing use of AI/ML in drug de­vel­op­ment.

In a 17-page pa­per pub­lished Ju­ly 10, EMA lays out the role of AI and ML through­out the life­cy­cle of med­i­c­i­nal prod­ucts. Fur­ther reg­u­la­to­ry guid­ance on risk man­age­ment in drug de­vel­op­ment will be forth­com­ing, the agency says.

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