Translating for EMA Approval

EMA Approval. What exactly is that? Companies exporting or testing a biotech products from a non-EU member country must not only keep up-to-date with specific European Medicines Agency (EMA) requirements, they must also be prepared to tackle the issue of language.

EMA Approval | Why Expert Translation?

Although biotech and life sciences companies are primarily focused on the product development process, clinical testing and gaining approval from regulatory authorities, the translation quality of regulatory documents is of equal importance. Accuracy, clarity and consistency, along with formatting and proper labeling, can dramatically affect the time frame for regulatory approval, including in the European Union (EU) where there is the additional issue of multiple languages.

Linguistic Review for EU Approval

The exportation of biotech products into the EU is a multi-step and time consuming process. Foreign biotech companies must be aware of specific European Medicine Agency’s (EMA) requirements to obtain EU marketing approval. Moreover, these regulations change over time. A look in the 2015 regulatory guidelines emphasizes the new requirement for a pre-opinion linguistic review, a process that impacts only new Marketing Authorization Applications since May of 2015:

“A linguistic review of product information in all EU languages is performed after the adoption of CHMP [Committee for Medicinal Products for Human Use] Opinions to ensure high quality and consistent product information of Centrally Authorized Products (CAPs) in all Member States. Such post-opinion product information linguistic review is part of the Commission Decision-Making Process (DMP).”

The requirement that translation of product information undergo linguistic review in all EU languages emphasizes the role of translation in the commercialization of a biotech product in the EU. Beyond the number of official EU languages, there are specific time frames associated with these applications.

List of EU Languages:

EMA Approval | Choosing A Linguistic Partner

When searching out a translation services agency to handle this type of project, it is critical to identify firms that have prior life sciences translation experience who can guarantee that they will meet the stringent regulatory requirements and often challenging deadlines associated with these projects. It is common for companies to partner with a language service provider that has a history of success in the region.

In order to receive approval for the commercialization of your product in the EU, you need to present your product documentation in all official EU languages to the EMA for review after an opinion is reached. The documentation required includes but is not limited to the following:

• Summary of Product Characteristics (SmPC)
• Patient Information Leaflets (PIL)
• Labeling and Packaging
• Marketing Authorization Dossiers
• Expert Reports
• Validation Protocols

About Language Connections:

Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.

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