EMA Releases a Reflection Paper on the Role of AI in Drug Development

EMA Releases a Reflection Paper on the Role of AI in Drug Development

The European Medicines Agency (EMA) has released a reflection paper outlining its thoughts on integrating artificial intelligence (AI) in supporting the progression, oversight, and utilization of human and veterinary medicines. This document covers AI’s application from drug discovery to post-authorization.

Part of the HMA-EMA Big Data Steering Group’s efforts, this paper is a collaborative endeavor involving EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP).

EMA acknowledges the rapid growth of AI in pharmaceuticals and aims to address regulatory complexities. The agency invites developers, scholars, and regulators to engage in discussions to harness AI’s potential for patient and animal well-being.

AI tools can significantly aid data collection, transformation, and analysis throughout medicinal product lifecycles. They can eventually replace animal models, enhance clinical trial design, and expedite patient recruitment.

AI algorithms are already being employed in identifying suitable clinical trial candidates and monitoring patients in real time through wearable devices and other digital means. AI has a potential to streamline data collection, management, and regulatory submissions, minimizing errors.

AI can support marketing authorization by aiding data compilation, translation, and review. In the post-authorization phase, it assists pharmacovigilance and adverse event management.

The paper emphasizes a human-centric approach to AI integration, adhering to legal, ethical, and fundamental rights considerations.

Stakeholders are encouraged to offer feedback on the paper until December 31, 2023. A collaborative HMA/EMA workshop in November 2023 will further discuss AI’s role in medicine, shaping the final reflection document and future guidance.

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