Translating For EMA Approval

Script:

• Companies exporting or testing biotech products from a non-EU member country must not only keep up with specific European Medicines Agency (EMA) requirements. they must also be prepared to tackle the issue of language.
• The importance of translation
• When it comes to clinical testing and gaining approval from different regulatory authorities, the translation quality of submitted documents is of great importance.
• Accuracy, clarity, and consistency, along with formatting and proper labeling, can dramatically affect the time frame for regulatory approval, especially in the European Union (EU) where multiple languages are involved.
• Linguistic review for EU approval
• Foreign biotech companies must be aware of specific European Medicine Agency’s (EMA) requirements to obtain EU marketing approval.
• EMA requires that translation of product information undergo linguistic review in all EU languages before being sold in the region.
• EMA approval and choosing a linguistic partner
• When searching for a translation services agency to handle this type of project, it is critical to identify firms that have prior life sciences translation experience and can guarantee that they will meet the stringent regulatory requirements.
• The documentation required includes but is not limited to the following:
• Summary of product characteristics (SmPC), patient information leaflets (PIL), labeling and packaging, dossiers, expert reports, validation protocols, and more…

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