EMRN Unveils Pioneering Workplan to Integrate AI into European Medicines Regulation

by | Dec 20, 2023

The European Medicines Regulatory Network (EMRN) has revealed a new plan that outlines its strategy for utilizing Artificial Intelligence (AI) in medicines regulation. This move comes as the pharmaceutical industry increasingly relies on AI tools for drug development and monitoring. By integrating AI, the EMRN aims to improve efficiency, enhance data analysis, and drive innovation in regulation.

The plan, adopted by the EMA’s Management Board, shows the network’s commitment to incorporating AI into medicines regulation. Spanning from the present year until 2028, it provides a roadmap for leveraging AI in four areas: guidance, policy, and product support; AI tools and technology; collaboration and training; and experimentation.

One of the main goals of the plan is to automate processes and systems to increase productivity. AI can streamline administrative tasks, allowing professionals to focus on more critical work. Automation can also improve accuracy and reduce human error, leading to safer evaluations of medicines.

The plan emphasizes the importance of collaboration and training. The EMRN seeks partnerships and knowledge-sharing to navigate the challenges and opportunities of AI effectively.

To promote transparency, the EMRN has started a public consultation on the AI reflection paper. This allows experts and the public to contribute insights and shape the future of AI in medicines regulation.

The plan aligns with the forthcoming EU AI Act to harmonize practices and build trust in AI-powered tools. National authorities also recognize the potential of AI and are developing and utilizing AI tools to navigate complex datasets and make informed decisions.

With this workplan, the EMRN takes a significant step towards integrating AI into medicines regulation. By embracing AI, the network aims to enhance productivity, automate processes, gain deeper data insights, and support decision-making. Collaboration, transparency, and training ensure regulators are prepared to harness AI’s full potential.

Regulatory bodies must adapt and use emerging technologies effectively. The EMRN’s AI workplan demonstrates a proactive approach in embracing AI and ensuring the safety, efficacy, and accessibility of medicines. Through implementation and improvement, the EMRN leads in harnessing AI for public and animal health.