Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.

26 April 2021

The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.

The just published annual report for 2020 shows that the year 2020 was marked by the COVID-19 pandemic and its ensuing consequences. But the year also saw the launch of the Danish Medicines Agency's new national register of medicinal products (LEOPARD) and the official opening of the Danish Medicines Agency’s new Data Analytics Centre, a centre that helps Denmark maintain its strong position in the European collaboration.

COVID-19 handling

The COVID-19 pandemic had a profound impact on the work of the Danish Medicines Agency, and a crisis management team was formed as early as February 2020. The agency has since contributed to many areas of work, including having:

  • participated in national and international efforts to mitigate supply problems and ensure ongoing monitoring of the supply levels of critical medicines
  • activated the drug preparedness for medicines and medical devices to meet changing requirements within consumption, supply and distribution following from COVID-19 
  • helped to generate a reserve of critical medicines through activation of the drug prepared-ness as well as established an action group and task force to ensure the supply of medicines
  • established a national overview of the supply of personal protective equipment and diagnostic tests as well as developed the Minerva system, an IT system that monitors the stocks of protective equipment and medicines
  • contributed to the work of the European Medicines Agency, EMA, by assessing the scientific data of marketing authorisation applications submitted by COVID-19 vaccine manufacturers
  • approved applications for clinical trials of medicines for COVID-19
  • built up a pharmacovigilance response system for COVID-19 vaccines

Assessment times for clinical trial approval

The Danish Medicines Agency was not bound by a performance contract in 2020, as the section on target fulfilment was suspended due to COVID-19. Reference is also made to the regularly updated assessment times on the links below:

Processing times for authorisation of medicinal products

Assessment times for notifications of clinical trial applications 2020

Opening of the Data Analytics Centre and strengthening of our European position
In 2020, the Danish Medicines Agency implemented two major systems on a new standard platform – a new national register of medicinal products and a new price reference system.

On the international scene, the Danish Medicines Agency retained its no. 4 ranking on the list of rapporteurships allocated to EU countries. In other words, the EMA delegated the responsibility of assessing and authorising new medicines to Denmark. In addition, the Danish Medicines Agency was also represented in the Competent Authorities for Medical Devices (CAMD) through the election of head of unit Thomas Wejs Møller as chair of the CAMD Executive Group for the next two years. Likewise, the Danish Medicines Agency was elected to fill the chair of the Working Group of Communication Professionals (WGC) under the Heads of Medicines Agencies (HMA) in November 2020, also for a two-year term.  

The Danish Medicines Agency is actively engaged in work on the board of the International Horizon Scanning Initiative (IHSI), which is a transnational collaboration between eight countries that aims to build a database intended to provide insights into medicines in the pipeline for authorisation and thus marketing in Europe. 

With a vision to promote the availability of effective and safe medicines and safe medical devices through better use of raw data, real-world data and advanced data analytics methods, the Danish Medicines Agency opened the Data Analytics Centre, DAC, in November 2020. An event commended by the EMA's new Executive Director with the words “Denmark delivers”. The development of the Data Analytics Centre will continue in the coming years.