EU Pharmacovigilance
The European Medicines Agency (EMA) has recently started translating safety signals into all 24 official EU languages, plus Icelandic and Norwegian. This means translating the recommendations that the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) issues on changes made to product information based on safety assessment into all of these languages.
New EMA Translation Measures Based On Safety Signals Assessments
New EMA translation measures to provide recommendations in all official EU languages are underway. These recommendations are made after assessments of safety signals by the PRAC. A safety signal is defined as information on a new or incompletely documented adverse event potentially caused by a medicine that must be further investigated. The EMA’s PRAC is responsible for assessing safety signals regarding any medicine approved for use in the EU. When a direct relationship between a medicine and a reported adverse event is confirmed, the PRAC will recommend that the product information be changed to ensure public safety – which often includes some form of life sciences translation services. The EMA’s new measures have the potential to improve patient safety by streamlining the translation process for updating product information.
Safety Signals | New Initiative Advantages
The new EMA translation measures are expected to accelerate the process of implementing changes to product information, providing greater consistency throughout EU member countries. In turn, this will allow patients to gain better access to information regarding the safety of their medications. It will also reduce the administrative burden and associated pharma translation costs that, until now, were the responsibility of the pharmaceutical companies. Since all translations will be coordinated by the EMA, duplication of effort will be eliminated.
Translation into EU Languages
Initially, the EMA will publish monthly recommendations on their website in English. Companies are expected to keep their product information in line with these recommendations. Therefore, if they are updated companies may have to undergo further pharmaceutical translation to update their products accordingly. Translations into EU languages of the EMA recommendations will be available three weeks after publication of the English online version, following a review of the translation services quality by the EMA, the EU’s national medicines regulatory authorities. A critical step in ensuring patient safety, translations must meet accepted standards for translating pharmacovigilance documents.
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