New data analysis centre to open at the Danish Medicines Agency

The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

Improved patient safety and tangible benefits for the life science industry. This is the expected outcome of the data analysis centre which the government today announced as part of its just launched plan to ease the burdens for the business sector. "Less bureaucracy, more growth. Proposal to ease constricting rules and administrative burdens for businesses".

The new centre for analysis of data on medicines and medical devices will be placed in the Danish Medicines Agency and is expected to ease the burdens for businesses by up to some DKK 150 million annually.

According to the plan, there is particular potential for easing burdens within the areas of clinical trials, medicines licensing and safety monitoring of medicines. In regard to clinical trials, it is hoped that the advice provided by the centre will mean that the pharmaceutical companies can plan their trials more accurately and targeted at certain patient groups and diseases. This will lead to savings in the form of fewer trial subjects, shorter trial periods, and fewer trials having to be altered or discontinued.

World-class data analysis

According to Thomas Senderovitz, Director General of the Danish Medicines Agency, the new data centre will put Denmark at the cutting edge of data analysis:

"With the new possibilities of data analysis, Denmark will reach world-class excellence when it comes to the use of data for the benefit of people and businesses. The initiative is a very important step for medicines safety and establishes the foundation for a completely new way of licensing and monitoring medicines. Today, the healthcare sector and new healthcare technologies generate more data than ever before, and it is crucial that we, as an authority, know how to analyse all these data in a way that will benefit society. With the new data analysis centre, we will be able to assess data from numerous sources for both medicines and medical devices in ways never seen before. We will also be much better positioned to be at the forefront of data security and data ethics".

In addition to strengthening the Danish Medicines Agency's analytical skills, the analysis centre is expected to enable the agency to deliver a more qualified and faster authorisation of applications for marketing of medicinal products – thus increasing the companies' possibilities of quicker earnings. Finally, the data analysis centre will be able to help the companies with digital systematisation of the many thousands of yearly safety signals of medicines (and medical devices) and with cross-cutting analyses of adverse reaction data and data on errors, failure or other incidents with medical devices.

The centre is expected to be established in 2019.

The analysis centre will work closely with the universities and other relevant stakeholders.

Read the entire plan in Danish here: Mindre bureaukrati mere vækst.