Pharma Industry Weighs In On EMA’s AI Regulation Proposals
Consistency and coherence with other relevant regulations should be a main priority for the European Medicines Agency when developing guidance on the use of artificial intelligence in the drug lifecycle, pharmaceutical industry representatives have said.
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The UK government says that its non-legislative approach to AI regulation will promote innovation and allow it to react quickly to changes in the ecosystem. But a life sciences lawyer warns that creating an uncertain regulatory environment could be problematic.
Companies that use AI technologies will be responsible for demonstrating that regulatory standards are met and that the data they provide “has not been synthetically generated or completely made up,” an EU workshop heard this week.
A two-day workshop saw EU policymakers and regulators meet with dozens of representatives from the pharmaceutical, health and medtech industries to discuss the future of regulating AI in medicine and its uses in the medicinal product lifecycle.