The European Medicines Regulatory Network is a unique model globally serving more than 500 million people in Europe and with access to thousands of experts. The network is made up of national competent authorities, the Heads of Medicines Agencies (HMA), who work together with the European Medicines Agency (EMA). Future focus will be on the acceleration of licensing processes – including making use of artificial intelligence.
The network of the heads of the regulatory authorities responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area (abbreviated as HMA), was founded in 1995. The HMA concerns itself with important strategic questions, provides consistency within the EU, and discusses tried-andtested processes. The work is shaped by a common vision: quick access to secure and effective medicines for the people of the EU.
The HMA works in and with the European Medicines Agency (EMA) and is able to access resources and expertise from all over Europe. This expertise is introduced into the EMA committees, which concerns itself with the evaluation of new drugs or the monitoring thereof. This ensures that the regulation of medicines meets the highest scientific standards.
“Our mode of operation and the regulatory environment has changed a lot over the years. We are experiencing a dynamism in the network which we have previously never experienced,” says Prof. Dr. Karl Broich. He is President of the Federal Institute for Drugs and Medical Devices (BfArM), member of the HMA and chair of its management group (HMA-MG) since 2019. “Digitalisation has become much more important, for example because of the coronavirus pandemic. We experienced how in Europe it‘s so important to work together and also be able to access common data and networks.” Society continues to develop, and this also applies to the HMA, says Broich: “In mutual lessons-learned workshops, we looked in depth at the question of how the network should be set up and changed in order to be future-proof. The necessary competences and resources need to be built up to meet the ever more complex products and technologies.” It‘s also clear that the regulatory processes should be accelerated and simplified wherever possible without compromising the quality.
Artificial intelligence will change a large part of the environment in which we work, and it will also change healthcare and the development of new treatments.
PhD Björn Eriksson, Director General of the Swedish Medical Products Agency
This is also where artificial intelligence (AI) comes into play. PhD Björn Eriksson, Director General of the Swedish Medical Products Agency (MPA), is certain: “Artificial intelligence will change a large part of the environment in which we work and it will also change healthcare and the development of new treatments.” Eriksson has been in the position of Vice Chair of the HMA-MG since 2023.
He advocates for the European regulatory networks playing a strong role in the application of AI: “Europe will be measured against other regulatory authorities around the globe with regard to agility and speed. We need to offer incentives and position ourselves appropriately to present the EU as an attractive region for medical innovations.”
The Swedish MPA already started working with AI in 2020. At the same time, the application of AI in medical technology is advancing, for example, in diagnostic disciplines such as radiology. “The development is happening very rapidly, and we need complex systems and qualified personnel to understand the opportunities and risks of AI,” Eriksson stresses. “This requires expertise across sectors, so not just pure AI expertise. It is also about training our own people accordingly.”
Expanding our pool of experts is a matter which the HMA is actively pushing ahead with. The HMA and EMA therefore started a pilot project in May 2023, which is aimed at oncologists. They are provided with regulatory fundamentals in an inhouse created program so that they are able to incorporate their knowledge in a very targeted way into the evaluation of medicines. A project which, in a similar form, is conceivable as an AI application.
“In many areas of our work, the chasm between developers and users is a major challenge,” explains Eriksson. “As the HMA, we want to contribute to the network in order to overcome this divide. Especially when it comes to innovative treatments that should be made available quickly.” The potential for the application of artificial intelligence in medicines regulation is major and the time is right: “AI has moved forward in public discussion and people are starting to see concrete examples of its application in everyday life.”
In the evaluation of AI, particular focus is placed on the analysis of large quantities of data. Development has gained significant dynamism, particularly in data analysis. The fundamentals of such analyses are the standardisation of data. It is the prerequisite for ensuring that these can also be used uniformly and intelligently across the EU. In collaboration with the EMA, the HMA therefore set up the database “Data Analytics and Real World Interrogation Network” (DARWIN EU), which collects “real-world data” (RWD). This does not stem from clinical studies, but from everyday medical care and is gathered, for example, by health insurers or care givers. This data is therefore becoming increasingly important for regulatory decision-making. The evidence generated from this can be relevant for evaluating the efficacy of a drug as well as for the phases before and after licensing. DARWIN EU generates an entire network consisting of healthcare data sources. The aim is to be able to carry out scientific analyses of regulatory questions securely and in line with data protection.
The application of new technologies and the findings gained from Big Data will be a benefit for public health, by accelerating the development of drugs and enabling earlier access to new treatments.
Prof. Dr. Karl Broich, Co-Chair of the DARWIN EU Advisory Board
“The research network also initiates studies to collect findings using RWD. We will use this to further improve data analysis in the evaluation of drugs,” explains Prof. Broich, who is also Co-Chair of the DARWIN EU Advisory Board. “The application of new technologies and the findings gained from Big Data will be a benefit for public health, by accelerating the development of drugs and enabling earlier access to new treatments.”
The HMA network is aware of the need to change – furthermore, it is committed to changing itself so that it can better meet its mission: to create added value for all of our interest groups, in particular patients in Europe.
