Better use of data and new technology

Data and AI play an increasingly significant role in the life sciences sector, which is experiencing rapid development. With this comes a wide range of opportunities, but also increasingly demanding requirements placed on us in our capacity as the responsible authority in this domain. To keep up with this development, the DKMA must ensure a strong data and AI foundation that both supports our external actors and strengthens our own processes and core tasks.

Over the recent years, we have focused our efforts on better use of data and the development of new AI methods. This work will continue in 2025, as there is still a need to build the right competencies and knowledge, leverage Denmark’s unique health registries for advanced data analysis and integrate data and AI into our regulatory work. When we use data and AI to develop and improve our processes, we will be able to make more effective, data-driven decisions, generate knowledge and maintain our position as a strong player in relation to our surroundings, thus promoting ourselves nationally and internationally.

At the same time, the green transition has increasingly spread to the life sciences industry and the healthcare sector in general. It raises the need for us to engage with a development that requires us to have the knowledge and competencies needed to enter into dialogue on framework conditions for the green transition and concrete environmental sustainability initiatives.

The implementation of the EU’s Corporate Sustainability Reporting Directive (CSRD) along with the new requirements for ESG reporting (environmental, social and governance) for businesses, which is to be phased in gradually, with applicability for the fiscal year 2024 for the biggest corporations. It is expected to have a considerable impact on how European life sciences businesses focus on sustainability and promote innovation in sustainable solutions and technologies as a competitive advantage, both nationally and internationally.

From an authority perspective, we wish to support and promote the sector’s green transition. By working with the Danish life sciences industry, Nordic alliances and European collaborations, we wish to get actively involved in steering the EU legislation in a direction that promotes sound framework conditions for sustainable solutions and reduces the environmental impact of the life sciences sector. Not only does this support national and international climate goals, it also promotes innovation and competitiveness in the sector.

We will let this benchmark guide us towards fulfilling the following two focus areas in 2025:

• We use data and new technologies to develop our core business
• We support innovation in the life sciences ecosystem

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