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What Is Regulatory Translation?

By A. Leverkuhn
Updated May 23, 2024
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Regulatory translation is the translation of documents for the purposes of complying with the requests of regulatory agencies in particular countries or parts of the world. This kind of language translation usually aims to effectively allow regulators in a foreign country to review presentations on products, so that they can be approved for market uses. This high-level type of translation requires specific skills, since the medical field is a highly technical part of most national economies, and the requirements for international medical commerce can be relatively complex.

Those who are involved in regulatory translation need to understand the sophisticated subject matter involved in medical product reviews or similar processes. Some of this requires knowing about international standards for medicine or science in general. In other cases, translators need to understand how to make one region’s language on medical standards fit the standards of another nation or region, where medical terminology or conventions may be substantially different.

Some specific tools can help regulatory translators to pursue more effective international presentations for their employers. Knowledge of central languages of origin, such as Latin, can be helpful, especially since so much of modern medical language refers back to this classic tongue. Knowledge of international medical coding can also be beneficial. It is often critical for translators to have intimate knowledge of the regulatory agencies that they are preparing to address with translated text.

There are also challenges in regulatory translation related to the complexity of documents around regulatory approval. These documents can be in many different forms, where spreadsheet documents, advanced charts, and other types of visuals can complement simple text documents. Common kinds of regulatory translation documents include risk assessments, technical writing on drugs or medical devices, and general “dossiers” on a product or device.

Some experts describe a dedicated process for regulatory translation. This starts with collecting the appropriate data from the source or sources, then editing to achieve the desired tone. The text may then go through various levels of publishing before being presented in the native language of regulators. Within this process, there will often be a dedicated fact-checking process, or even a process of oversight or review where one person may check another person’s work. This is not just to ensure accurate translation, but also to pursue clarity in the top-level goals of the documentation, that is, to appeal to the interests of regulators, and provide the best chance for a positive outcome.

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