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Swedish translation available in MedDRA - a standardised medical terminology

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MedDRA (Medical Dictionary for Regulatory Activities) is a standardised medical terminology used to facilitate the sharing of regulatory information and among other things may be used as terminology in safety monitoring of medicinal products.

MedDRA could be described as a hierarchical structure of approximately 80 000 medical terms. A formal Swedish translation has not been available until now which have resulted in different terms for the same definition of a term, (such as hypertonia/high blood pressure) in product information of medicinal products.  

The translation has been performed by the MedDRA organisation and quality assured by the Swedish Medical Products Agency. The translation is available in the MedDRA Web-Based Browser.  

MedDRA is already available in the following EU languages: English, Czech, Dutch, French, German, Hungarian, Italian, Portuguese, and Spanish.

To be translated into all EU languages

According to EMA (the European Medicines Agency), the Swedish initiative has been an inspiration for EMA to coordinate translation of MedDRA into the rest of the EU languages within four years.

A formal translation into all EU languages will facilitate the work with electronically structured product information. A harmonised translation will also facilitate the work with adverse events reports. 

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The Swedish Medical Products Agency is the national authority responsible for regulation and surveillance of the development, manufacturing and sale of pharmaceuticals and other medicinal products.

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