The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to guide the use of AI in medicines regulation until 2028.
Recently adopted this month by the EMA’s Management Board, the workplan aims to set out a collaborative and coordinated approach to maximise the benefits of AI to stakeholders while managing the risks.
At present, pharmaceutical companies are increasingly using AI-powered tools in research, development and to monitor medicines.
Most recently, Merck & Co – known as MSD outside the US and Canada – announced it had entered into a collaboration with French-American biotechnology company, Owkin, to develop and commercialise AI-powered diagnostics for cancer.
Prepared under the joint HMA-EMA Big Data Steering Group (BDSG), the Multi-annual AI workplan 2023-2028 will help the European Medicines Regulatory Network (EMRN) to utilise AI for personal productivity, automate processes and systems, increase insights into data and support more robust decision-making to benefit public and animal health.
Additionally, the workplan will ensure that the EMRN will continue to benefit from AI in medicines regulation.
“The application of AI requires a collaborative, coordinated strategy to maximise the benefits from AI while ensuring that uncertainty is adequately explored and risks are mitigated,” the document states.
Focusing on four key dimensions: guidance, policy and product support; AI tools and technology; collaboration and training; and experimentation, the work plan addresses the new opportunities and challenges of starting to use and develop AI tools.
It highlights the aims of identifying and providing frameworks across networks to use AI tools, plans to continuously develop the capacity and capability of the network, partners and stakeholders in relation to the growing field of AI and implementing several actions to ensure a structured approach to experimentation across the network.
Currently, work has already started for the ongoing public consultation on the AI reflection paper, which is open until the end of December 2023 and preparations to implement the EU AI Act will begin in 2024.
The BDSG will continue to regularly update the AI workplan and regulators, medicine developers, academics, patient organisations, and other parties will be updated throughout the implementation of the plan.