Our Involvement in the PRAC

The Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) is responsible for monitoring and evaluating the safety of medicines for human use.

The PRAC is composed of the following:

• the Chair (elected by the PRAC members)
• one expert plus an alternate of the medicines agency from each of the EU member states as well as the EEA member states Iceland and Norway. The German member and alternate are sent by the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI).
• six independent scientific experts nominated by the European Commission
• one member and an alternate from patients organisations nominated by the European Commission.

The Paul-Ehrlich-Institut (PEI) is currently represented on the PRAC by a pharmacovigilance expert and specialist in neurology from the Safety of Biomedicines and Diagnostics Division.

This page provides important safety information on vaccines and biomedicines from the PRAC meetings. Information on medicines for human use outside the area of responsibility of the Paul-Ehrlich-Institut can be found on the website of the Federal Institute for Drugs and Medical Devices (BfArM).

On this page you will find important information on the safety of vaccines and biomedicines from PRAC meetings. Information on medicinal products for human use outside the area of responsibility of the Paul-Ehrlich-Institut can be found on the website of the Federal Institute for Drugs and Medical Devices (BfArM).

PRAC Recommendations within EU Referral Procedures

An EU referral procedure is a risk assessment procedure carried out by an EMA committee. Referrals may be carried out for a variety of reasons, including an investigation into safety concerns.

The PRAC provides monthly information on recommendations as well as any EU referral assessments that have been initiated or are ongoing. The table below contains PRAC notices regarding centrally und nationally authorised vaccines and biomedicines.

PRAC Recommendations on Safety Signals

Safety signals contain new information concerning the safety of an authorised medicinal product, such as previously unknown adverse events following the administration of a medicinal product or new aspects of already known events requiring further investigation. Safety signals are generated from various sources, such as the analysis of spontaneously reported suspected side effects, clinical trials, or scientific literature. The PRAC examines information on new safety signals and decides if any additional assessments should be carried out by the marketing authorisation holder, when the results must be presented to the PRAC, and whether risk-minimising measures need to be taken.

The detection of safety signals and risk management are important instruments of pharmacovigilance that allow for the early detection of previously unknown medicinal product risks or an unexplained sudden increase in medicinal product risks and to minimise them. Not every new piece of information in the field of pharmacovigilance automatically represents a new safety signal and not every safety signal represents a new medicinal product risk.

Every month, the EMA publishes an overview of all safety signals discussed at the last PRAC meeting, as well as any recommendations on signal management that may have been adopted. The table below contains PRAC recommendations for centrally and nationally authorised vaccines and biomedicines.

2024

2023