EMA to Translate Safety Signal Recommendations

Regulatory NewsRegulatory News | 18 February 2015 |  By 

In an effort to improve the timeliness and consistency of product information changes, the European Medicines Agency (EMA) is now translating recommendations in all official EU languages, plus Icelandic and Norwegian.


In the EU, pharmaceutical companies are required to provide translations of product information to EMA after a product is authorized. The translations must be made in all official EU languages, including Icelandic and Norwegian.

From time to time, product information must be updated to reflect recommendations made by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The recommendations are made following PRAC’s monthly assessment of safety signals, which EMA defines as “information on a new or known adverse event that is potentially caused by a medicine.” PRAC recommendations usually involve making changes to the summary of product characteristics (SmPC) and package leaflet. These changes must be translated for product information in all official EU languages.

Speeding Product Information Updates

Beginning with the January 2015 PRAC recommendations, EMA says it will translate PRAC recommendations into all 24 official EU languages, plus Icelandic and Norwegian within three weeks. The translations will be validated by the individual regulatory agencies for accuracy before being published to the PRAC recommendation page. Translations for the January 2015 meeting are already available in 25 languages (Irish appears to be missing from the list).

EMA says by providing translations of PRAC recommendations, companies will have an easier time applying the recommended changes to their product information in a timely manner. Additionally, the agency says this will cut costs for pharmaceutical companies while increasing the consistency and reliability of product information for patients.

The European Union places great importance on the availability of translated documents for EU citizens. EMA’s new measures have the potential to improve patient safety by streamlining the translation of product information updates.


EMA Press Release


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