Activities in the EU and the rest of the world

16 April 2019, Updated 24 April 2019

The Danish Medicines Agency’s vision is to become one of Europe’s best in class, and we work to develop the area of medicines and medical devices both in the EU and the rest of the world. We do this to ensure that effective medicines and medical devices, by means of the latest knowledge and technology, are made accessible to those who need them.

The medicines and medical devices areas are based in particular on European legislation and close and effective collaboration in the EU where the EU countries pool their competencies in relation to, for example, medicines licensing as well as share knowledge and acknowledge each other’s inspections and laboratory controls, etc.

The Danish Medicines Agency thus participates in numerous European and international networks and forums to influence the development within the politically adopted frameworks. The European and international collaboration strengthens and expands our own expertise within different disciplines, which is vital for our national regulatory work.

Strong positioning in the international collaboration between authorities

Especially in EU matters, we play an active role in terms of supporting and taking part in joint European work that involves medicines and medical devices.

On the international stage, the Danish Medicines Agency has entered into strategic sector cooperation agreements with China and Brazil.

We have also established cooperation agreements with the drug regulatory authorities in the USA and Japan – particularly with the intention of acquiring knowledge in areas where these players hold strong positions. These cooperation agreements support our ambition of reaching European and international excellence.

EU

Especially four European entities work with the regulation of medicines and medical devices in the EU. They are:

  • The European Commission
  • The European Medicines Agency (EMA)
  • The Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA
  • The Competent Authorities for Medical Devices (CAMD) – a network for the national drug regulatory authorities in the EU/EEA that are responsible for activities related to medical devices

All of these entities cooperate closely so they can allocate resources from across the EU to the regulatory processes. In this setup, the EU has access to thousands of experts from the national authorities, helping to ensure that the regulation of medicines and medical devices meets high standards at all times.

The Danish Medicines Agency is an active player in this work.

In the following, you can read more about the four key players and how the Danish Medicines Agency actively engages with them.

The European Commission

The Directorate-General for Health and Food Safety (DG SANTÉ) develops and implements the European Commission’s food and public health policies, including medicine policies. In parallel, DG SANTÉ works to strengthen the internal market by promoting innovation and competition. The responsibility for medical devices lies with the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).

One of the EU’s core principles is that a medicine can only be placed on the market if a marketing authorisation has been granted by an authority.

On the European level, it is the European Commission which is responsible for granting the so-called centralised authorisations for new medicines, whereas the national medicines agencies authorise the medicines that are not in this category via the so-called decentralised procedure. A central authorisation implies that the medicine can be marketed across the EU at once.

The European Medicines Agency

The European Medicines Agency (EMA) coordinates the review of medicines to be authorised under the centralised procedure and thereby also the contributions made by the national drug regulatory authorities in this process. In other words, the EMA is the focal point for the approximately 40 national drug regulatory authorities in the EU, and this ensures a continuous exchange of information on the scientific assessment of new medicines in the EU.

The Danish Medicines Agency prioritises working closely with the EMA, and we are very active in EMA working parties and also represented in the EMA Management Board.

Read more about the EMA here:The EMA website.

Read more about the authorisation procedure on the website of the Danish Medicines Agency: Licensing of medicines.

Heads of Medicines Agencies (HMA)

The HMA is a collaboration between the national medicines agencies in the EU/EEA consisting of the managing directors of the more than 40 drug regulatory authorities responsible for the regulation of human and veterinary medicines.

The HMA discusses strategic key challenges (with the EMA and the European Commission) such as IT development and knowledge sharing. The focus is on development, coordination and harmonisation of the work with medicines, and the HMA is instrumental in ensuring the most efficient use of resources in the network, e.g. through worksharing and coordination of procedures for the decentralised authorisation of medicines and for the mutual recognition of medicines.

The Heads of Medicines Agencies meats four times a year. At these meetings, working groups and task forces are established to cover relevant topics – sometimes in collaboration with the EMA.

At these meetings, a Management Group (HMA MG) is elected. The HMA MG is responsible for coordinating and facilitating the work of the HMA. The HMA MG is facilitated by a Permanent Secretariat (HMA PS) which improves, coordinates and follows up on the work of the HMA.

The Danish Medicines Agency chairs the HMA MG and therefore plays a central role in the HMA collaboration. The Danish Medicines Agency is also represented in the HMA PS and in many of the working groups.

Read more about the HMA here: The HMA website.

Read more about the authorisation procedure on the website of the Danish Medicines Agency: Licensing of medicines.

Competent Authorities for Medical Devices (CAMD)

The CAMD is an umbrella organisation for the national authorities in the EU responsible for tasks related to medical devices. Its main purpose is to strengthen the area’s regulatory work in the EU. The Danish Medicines Agency is represented in the CAMD Executive Group, a subgroup of the CAMD which together with the European Commission is responsible for strengthening the strategic planning and the division of work in the organisation.

The CAMD has three objectives:

  • Enhancing the collaboration across frontiers
  • Improving market surveillance
  • Delivering better communication

To fulfil these objectives, the CAMD regularly launches projects to support the member states’ efforts and ensure an appropriate division of tasks between the stakeholders involved.

Read more about CAMD here:The CAMD website.

 


Collaboration with countries outside the EU

Below, you can read more about the cooperation agreements the Danish Medicines Agency has concluded with countries outside the EU.

China

Since 2009, a cooperation agreement has been in place between the Danish Medicines Agency and the Chinese drug regulatory authorities. Through this agreement, we have inspired China’s work with developing procedures for medicines licensing and more.

This agreement was strengthened further with the establishment in 2017 of the China-Denmark Food and Drug Regulatory Cooperation Centre. The cooperation is entering a new phase with the strategic sector cooperation on health in China, in which the Danish Medicines Agency is heading a sub-project on medicines and medical devices. From 2019-2021, the Danish Medicines Agency will be involved in about 25 activities which will include the control of radiopharmaceuticals, the training of assessors and inspectors, and the exchange of information on new technologies in medical devices. 

The collaboration with the Chinese drug regulatory authorities contributes to the protection of public health in China. It is about capacity building, inspiration on how to optimise processes in the regulation of pharmaceutical companies, harmonisation of the regulatory work, and mutual experience sharing.

Brazil

Since 2016, the Danish Medicines Agency has had a cooperation agreement with the Brazilian Health Regulatory Agency (ANVISA) in a number of defined areas. The aim is to offer inspiration and share experience for continued development of the areas covered by the agreement. The cooperation is entering the next phase with a further three-year period which will especially focus on the areas of clinical trials, pharmacovigilance and medical devices.

USA

Acknowledging that the execution of tasks in a highly-specialised drug regulatory authority is data-driven, the Danish Medicines Agency entered into an agreement with the American Food and Drug Administration (FDA) in January 2018 to acquire knowledge about how the USA approaches the use of data in connection with post market surveillance of medicines and how it handles complex clinical trials.

Japan

Since January 2017, the Danish Medicines Agency has had a cooperation agreement with the Japanese drug regulatory authorities. It focuses on the analysis of different types of health data that can be used to assess the efficacy and safety of medicines. It is an area where the Japanese drug regulatory authorities successfully apply effective tools that could serve as an inspiration for how we could to do things in Denmark.

WHO

In spring 2019, the Danish Medicines Agency entered into an agreement with WHO on assistance to help build drug regulatory authorities in low- and middle-income countries. As one of the first countries in the world, Denmark will contribute specifically to capacity building in the drug regulatory authorities of selected countries – including Africa – to enable these countries to better fulfil the tasks related to, for example, the licensing of new medicines and the monitoring of side effects of the medicines used by the country's population.

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