The Pharmacovigilance Risk Assessment Committee

Strengthening surveillance of medicines throughout the EU

Article date: July 2013

The EU Pharmacovigilance Risk Assessment Committee (PRAC) (PRAC) is a scientific committee at the European Medicines Agency that is responsible for the assessment and monitoring of the safety of medicines. This includes the detection, analysis, risk minimisation and communication of adverse reactions. PRAC is a fairly new committee, established as part of new EU pharmacovigilance laws that came into effect in July 2012 to help strengthen the safety monitoring of medicines across Europe.

For any medicine on the EU market, it is essential that the expected benefits outweigh the risks in the treated population. The work of PRAC always aims to ensure that the benefits of a medicine are optimised in use while the risks are kept to a minimum. Much of the vital information that you read in Drug Safety Update is the output of this ongoing monitoring, and our aim is to continually bring you the latest advice in a timely way once PRAC has concluded a particular review of a medicine.

For example, the committee’s work will commonly include updates to product information (both in the summary of product characteristics and patient information leaflet) or restriction of the indication for a medicine. Drug Safety Update will bring you news of such risk minimisation: for example, this month we are informing you that codeine now has restricted use in children.

Rarely, a medicine will be withdrawn from the market if the risks associated with a medicine are found to outweigh its benefits (see for example, PRAC’s recommended suspension of use of hydroxyethyl starch products in June 2013 due to safety concerns).

PRAC also has oversight of the EU-wide additional monitoring scheme for medicines of particular interest (which carry a black triangle ▼—see Drug Safety Update, May 2013,

PRAC meets every month, and agendas and highlights of the meetings are published on the website of the European Medicines Agency. The committee has representation from drug regulatory authorities of European Member States (including UK). Importantly, advice from our UK independent Commission on Human Medicines and its expert advisory groups is fed in to these European discussions to help safeguard public health in the UK and wider.

PRAC also consists of the following members nominated by the European Commission: independent scientific experts; representatives of healthcare professionals; and representatives of patients’ organisations. In due course, when considered necessary by PRAC, members of the public will be able to attend or participate (in person on online) in public hearings on specific issues of drug safety.

Article citation: Drug Safety Update vol 6 issue 12: July 2013: O1.

Published 11 December 2014