Second strategic field of the EMA’s network strategy

The use of digital technologies is already reality and is applied to support regulatory decision-making in the different member states and to generate "real-world evidence". Hence, the authorities consider it very important to start with the implementation of policy regulations at EMA level immediately.

In connection therewith, the EMA refers to the "European Health Data Space" (EHDS), which is intended to promote the networking of data collected across the EU and therefore should contribute to improved regulatory decisions in the healthcare and pharmaceutical sector. This digital interconnectedness is expressed through four objectives, which are to be achieved in the context of data analysis and digital transformation.

1. Guaranteed access and analysis of routine and individual patient data from clinical trials as well as promotion of target data standardisation.
2. Development of sustainable capabilities and capacities in the areas of statistics, epidemiology, "real-world evidence" and advanced analytics.
3. Promotion of dynamic regulations and policy development within the framework of the current legislation.
4. Incorporation of data security and ethical considerations into the network's policies.

The challenges emphasised in the EMA's network strategy are mainly related to big data and to the lack of regulatory standards as well as to insufficient technical skills and capacities. Another significant issue is the poorly adapted, very static regulatory process.

Overall, this second field of the network strategy regulates the functional background of new technology usage and it also outlines the areas of application. The generation of "real-world evidence" is described as complementary to clinical trials, especially in cases where it is difficult to conduct a clinical trial with sufficiently large patient numbers, like with rare diseases. By building up new competencies at EMA level, the significance of this already very relevant authority will continue to grow.

The EMA and the HMA have identified the digital challenges which national authorities will face in the upcoming years or that are already acute in some cases. Likewise, it has been recognised that these challenges need to be regulated not only centrally, but rather in line with the national authorities. Further developments, especially regarding Big Data and uniform regulatory data standards, are to be expected from the legislative side. SKC continuously monitors new impulses on this topic very closely, in order to offer the best possible solutions to clients in a rapidly changing environment