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The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.
The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.