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European Medicines Agency begins to publish recommendations based on safety signals


The European Medicines Agency (EMA) has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC). The document covers all safety signals discussed during the September 2013 PRAC meeting and the recommendations given for each of them. It includes PRAC recommendations for centrally and nationally authorised medicines.

The evaluation of safety signals by the PRAC has been implemented with the new pharmacovigilance legislation. A cumulative list of all signals discussed at the PRAC since September 2012 available on the EMA web pages or here.

The evaluation of safety signals is part of routine pharmacovigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine’s benefits and risks. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. One of the most important sources is also EudraVigilance, the central European database.

The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient. The evaluation of safety signals is required to establish whether or not there is a causal relationship between the medicine and the reported adverse event.

The PRAC carries out an analysis, classification according to the importance and the evaluation of the signal within the procedure of signal management in the EU, after which it provides recommendations that may be associated to any medicine authorised in the EU

In cases where a causal relationship is confirmed or considered likely, PRAC may ask for additional information from the marketing authorisation holder for medicinal products with the signal concerned. Prac recommendation may include regulatory actions such an an update of the summary of product characteristics (SmPC) and the package leaflet. Where this concerns a centrally authorised medicine, the recommendation from the PRAC is submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement of the EMA’s final opinion. PRAC recommendations for regulatory action concerning nationally authorised medicines are submitted to the Coordination Group for Decentralised and Mutual Recognition Procedures - Human (CMDh).

After this, marketing-authorisation holders are expected to take action according to the recommendations. Marketing-authorisation holders should monitor the information in the overviews regularly to keep informed about the PRAC recommendations concerning their products.

EMA will publish future PRAC overviews following each month's CHMP and CMDh meetings.

Detailed information about the signal management and obligations of marketing authorisation holders are available in the following documents