Pharmaceutical Translation Services
for the European Union’s Fast Track
Approval Process for
US Pharmaceuticals

Multilingual Pharma Translation Services for the Foreign Made Pharmaceuticals

Recently the European Union issued a new, fast-track review process for approving foreign made pharmaceuticals to be sold in the European Union. Since the European Union operates under numerous languages, it is important that any application for pharmaceutical approval under the EMEA fast-track system be submitted with the proper pharmaceutical foreign language translations. This becomes particularly important when trying to demonstrate the unmet need or improvement requirement under the Accelerated Assessment Procedure.

 

The Accelerated Assessment Procedure is administered by the European Medicines Agency (EMEA). In summary, a US drug maker can apply for accelerated assessment, if they can show that their product responds to an unmet medical need or constitutes a significant improvement over the available methods of prevention, diagnosis or treatment of a disease. If this standard is proved, under the fast-track process approval can be granted in as little as five months.

Although English is acceptable, it is common practice to also include, at the very least, an English into French translation of the application. Further, it should be noted that not all European countries are under the auspices of the EU or EMEA. Notable exceptions include Norway, Switzerland and many Eastern European countries.

Contact our patent translation firm to obtain pharmaceutical translation services.

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