EMA Finalizes AI In Medicines Paper After Reviewing 1,342 Comments

Many of the comments were very helpful in improving the document in relation to both form and content, the European Medicines Agency said of its newly published reflection paper on the use of artificial intelligence during the drug development, marketing authorization and post-authorization phases.

The EMA's paper on AI considers the fast-changing technical and regulatory landscape • Source: Shutterstock

The European Medicines Agency has finalized its reflection paper on the use of artificial intelligence (AI) during the lifecycle of medicinal products, after reviewing more than 1,300 comments from the stakeholders who gave their feedback on the draft version of the paper.

Key Takeaways

The EMA published the final version of its reflection paper on the use of artificial intelligence during the lifecycle of medicinal products on 30 September.

The final paper includes a number of updates compared with its draft version, such as providing further clarification regarding...