Leveraging data, digitalisation, and artificial intelligence: A new era for medicines regulation

In an era marked by rapid technological advancements and evolving healthcare needs, the European Medicines Agencies Network Strategy 2028 stands as a key document. It outlines a comprehensive plan to navigate the complexities of modern medicine, ensuring that regulatory processes are robust, adaptive, and forward-thinking. This strategy is crucial for safeguarding public health, fostering innovation, and enhancing the accessibility and availability of medicines across the European Union.

By leveraging data, digitalisation, and artificial intelligence (AI), the network aims to transform its operations, making them more efficient and responsive to the challenges and opportunities of the future. In the rapidly evolving landscape of healthcare, the integration of data, digitalization, and AI is not just an opportunity, but a necessity. This article delves into one of the key themes of the strategy, highlighting how – as we navigate through the complexities of modern medicine – these technological advancements can offer unprecedented potential to transform regulatory processes, enhance decision-making, and ultimately improve patient outcomes.

The power of data

Data is the lifeblood of modern healthcare. Over the past few years, the European Medicines Agencies Network has been processing an increasing amount of data to monitor the safety and efficacy of medicines, generate real-world evidence, and contribute to EU-wide health policies. This explosion of data presents both opportunities and challenges. The key lies in harnessing this data effectively to support decision-making while ensuring its integrity, security, and interoperability.

The network's strategy emphasises the importance of data governance and interoperability. By implementing and harmonising master data and related standards, we can ensure that data from one partner in the network can be seamlessly used by others. This interoperability is crucial for delivering stakeholder benefits and supporting the network's processes.

Digital transformation

Digital transformation is at the heart of the network's strategy. By leveraging digital technology, we can increase efficiency and automate many regulatory processes. This transformation involves continuous experimentation and the adoption of emerging technologies, with AI being a prime example.

AI has the potential to revolutionise the way we evaluate and monitor medicines. From enhancing the accuracy of clinical trials to predicting adverse drug reactions, AI can provide insights that were previously unimaginable. The network aims to harness the full potential of AI across all its themes, ensuring that it becomes an integral part of the regulatory landscape.

Real-world evidence and the European Health Data Space

One of the most promising aspects of leveraging data is the ability to generate real-world evidence. The network plans to embed the routine use of EU healthcare data, including data from the Data Analysis and Real World Interrogation Network (DARWIN EU) and individual patient data from clinical trials. This approach will provide a more comprehensive understanding of how medicines perform in real-world settings, leading to better-informed regulatory decisions.

The European Health Data Space (EHDS) will further reinforce the framework for generating evidence for EU decision-making. By ensuring that data use complies with the EU Data Protection Regulation and all applicable data protection, privacy, and cybersecurity requirements, the network can maintain the highest standards of data integrity and security.

Goals and objectives

The network's goals for leveraging data, digitalisation, and AI are ambitious yet achievable. These include maximising the generation, interoperability, use, and exchange of data to support EU decision-making, reinforcing the network's digital infrastructure, and fostering a culture of continuous experimentation and innovation.

By embedding the use of EU healthcare data in the network's processes, ensuring high levels of data interoperability, and leveraging AI to support digital business transformation, the network aims to create a future-proof regulatory environment. This will not only enhance the efficiency of regulatory processes, but also ensure that the network remains at the forefront of scientific and technological advancements.

Looking towards the future

As we look towards the future, the integration of data, digitalisation, and AI will be pivotal in shaping the regulatory landscape. By embracing these technologies, the European Medicines Agencies Network can enhance its ability to protect public health, foster innovation, and ensure that patients have access to safe and effective medicines. The journey towards this digital transformation is ongoing, but the potential benefits are immense, promising a brighter future for healthcare in the EU and beyond.

About the author

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Roberto Ascione is a digital health pioneer and recognised thought leader, serial entrepreneur, and global manager. He founded Healthware Group in 1997, which joined EVERSANA in 2023, where he serves as President of Health Innovation, continuing to drive global health innovation for a more accessible, sustainable, and ultimately human healthcare. He is Chairman of the Frontiers Health Global Conference and author of “Il Futuro della Salute” (Hoepli) and “The Future of Health” (Wiley). Ascione is a founding advisor to the Digital Therapeutics Alliance (DTA), President of Future Health Ventures (formerly Healthware Ventures), and a regular keynote speaker at global events. Trained as a medical doctor and in marketing communications, his passion for medicine, computer science, and human-technology interactions have led to his lifelong commitment and dedication to the advancement of digital healthcare.