Pharmacovigilance and the EU cooperation

Updated 19 March 2021

What is pharmacovigilance?

Pharmacovigilance refers to the monitoring of the safety of medicines. There are many different activities involved in this monitoring, for example:

Gathering and evaluating information on the safety of medicine use
Identifying and analysing possible signals regarding new or changed side effects of medicines during their use
Preparing plans on how to minimise risks in connection with the use of medicines

Medicines save lives, help cure diseases and reduce symptoms, but all medicines will have some kind of side effects. It is therefore important that we do what is in our power to ensure that medicines are safe by continuously monitoring possible side effect of medicines – and that we do this nationally and internationally (both within the EU and through collaborations with significant players outside the EU).

The monitoring of the safety of medicines involves patients, doctors, the pharmaceutical industry and authorities in and outside Denmark. A variety of pharmacovigilance tools are used. We describe these here.

Why is it that some side effects are not discovered before after marketing?

When a new medicine is to be authorised in the EU, it first has to pass thorough and comprehensive testing in clinical trials. During these trials, the medicine's efficacy is thoroughly assessed. At the same time, any side effects occurring during the use of the medicine are meticulously recorded. All medicines may cause side effects, and a medicine is only authorised if it can be established that the medicine’s beneficial effect outweighs the risk of the side effects observed for the medicine.

Despite the requirement for extensive documentation, it is not always possible to uncover all potential side effects of a medicine before it is taken into use. One of the reasons is that the patients who participate in clinical trials are specifically selected based on their age for example, and the trials are often conducted over a shorter period of time. Usually, the participants in a trial do not take any other medication as they have no other diseases than the one the medicine being tested is targeting. On top of that, the trial participants are followed carefully throughout the course of the trial to ensure they take the medicine correctly and to monitor how they are feeling. Once the medicine is rolled out to the general public, it is a different matter. This is why it may happen that new side effects emerge and that new precautions needs to be taken after a medicine has been put on the market. It is therefore important to have continuous monitoring in place via national and international pharmacovigilance systems designed to pick up any problems.

The EU cooperation and tools for monitoring medicines safety

The EU has a comprehensive cross-cutting collaboration system in place through which the safety of medicines authorised in Europe is continuously assessed. These cross-cutting European collaboration activities are coordinated by the European Medicines Agency (EMA) located in Amsterdam in the Netherlands.

At the Danish Medicines Agency in Denmark, we regularly assess the safety of selected products on behalf of the EU as do the other EU member states. In this way, it is ensured that the safety for all medicinal product on the market is monitored.
The Danish Medicines Agency and the rest of the EU have a wide range of pharmacovigilance tools at their disposal for the continuous monitoring of the safety of medicines. The monitoring tools used in the European cooperation are primarily these:

Periodic safety update reports (PSURs)
Signal detection and signal assessment based on European reports of side effects
Evaluation of the so-called post-authorisation safety studies (PASS) – studies carried out by pharmaceutical companies after marketing authorisation
Evaluation of the pharmaceutical companies’ risk management plans (RMPs)
Evaluation of data in connection with a so-called “referral”, an extraordinary procedure in which the Pharmacovigilance Risk Assessment Committee (PRAC) assesses all available data to resolve a particular issue regarding the safety and use of a medicine
The dispatch of notifications on the safety of medicines to doctors and other healthcare professionals, via the so-called direct healthcare professional communication (DHPC)

The EU Pharmacovigilance Risk Assessment Committee (PRAC)

The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of medicines for human use. The PRAC is a committee under the EMA and is made up of members from every EU member state. The PRAC issues recommendations on the safety of medicines based on the assessments contributed by each EU member state on behalf of the EU, which stem from their continuous monitoring of the safety of medicines with the tools described above. The PRAC meets once a month.

The main topics discussed and conclusions drawn at the PRAC meetings are posted on the EMA website after every meeting.