Safety signals: recommendations now available in all EU languages

18/02/2015

Translations will facilitate consistent implementation of product-information changes across the EU and reduce administrative burden for stakeholders

The European Medicines Agency (EMA) has started to translate its recommended changes to product information based on the assessment of safety signals into all official languages of the European Union (EU). The translations should be used by pharmaceutical companies to update the product information of their medicines.

This initiative is expected to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.

The EMA service will reduce the administrative burden and costs for the pharmaceutical companies, which, until now, have had to conduct translations individually with duplication of effort. It will also support the work of national medicines regulatory authorities in the EU, which are responsible for assessing the product informationproposed by pharmaceutical companies for nationally authorised products. The administrative and assessment burden should be minimised since companies’ proposals will be based on agreed translations.

A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that requires further investigation. The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing validated safety signals reported for any medicine authorised in the EU. When a causal relationship between the medicine and the reported adverse event is confirmed, the PRAC can, for example, recommend that the product information of the medicine be changed to protect public health.

PRAC recommendations are submitted to the Committee for Medicinal Products for Human Use (CHMP), for endorsement, if the signal concerns a centrally authorised medicine, or communicated to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) if the signal concerns a nationally authorised medicine.

Translations in all official EU languages, as well as Norwegian and Icelandic, will now be made available three weeks after publication in English, following a review of the translations' quality by the national medicines regulatory authorities of the EU Member States.

Translations of the January PRAC recommendations on safety signals have been published today: see PRAC recommendations on safety signals.