EMA: European Medicines Agency prepare for AI in regulation

A joint initiative of HMA and European Medicines Agency (EMA), the AI workplan has been adopted by EMA's Management Board in its December meeting

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Artificial intelligence Brain
Picture: Pixabay

Last Updated on December 28, 2023 by The Health Master

European Medicines Agency

In the rapidly evolving landscape of healthcare, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMAs) have taken a significant stride by unveiling a comprehensive plan.

This plan, designed in collaboration, aims to harness the full potential of artificial intelligence (AI) in the regulation of medicines.

The roadmap, extending until 2028, charts a course for the European medicines regulatory network (EMRN) to leverage AI for enhanced productivity, automated processes, data insights, and robust decision-making.

The AI Workplan: A Closer Look

Originating from the Big Data Steering Group (BDSG), a joint initiative of HMA and European Medicines Agency (EMA), the AI workplan has been adopted by EMA’s Management Board in its December meeting.

This strategic initiative is positioned to keep the EMRN at the forefront of AI’s benefits in medicines regulation.

Let’s delve into the four key dimensions of this groundbreaking AI workplan.

Dimensions of the AI Workplan

Guidance, Policy, and Product Support

  • Continuous support for products in development
  • Development and evaluation of guidance for AI in medicine lifecycle
  • Ongoing public consultation on the AI reflection paper
  • Preparations for EU AI Act implementation in 2024

AI Tools and Technology

  • Identifying and providing frameworks for AI tools
  • Ensuring compliance with data protection legislation
  • Enhancing efficiency and decision-making through AI

Collaboration and Training

  • Initiatives to develop the capacity of the network and stakeholders
  • Keeping ahead of the evolving field of AI
  • Continuous development of skills and capabilities

Experimentation

  • Acknowledging the role of experimentation in AI development
  • Structured approach to experimentation across the network
  • Actions proposed for accelerated learning and insights

Fast Evolution of AI Technology

As AI technology evolves rapidly, including ethical and policy aspects, the BDSG is committed to regularly updating the workplan.

This proactive approach ensures that the EMRN stays abreast of the latest developments, maintaining a balance between innovation and ethical considerations.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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