Regulatory translation is the translation of documents for regulatory agencies in foreign countries. It requires specific skills and knowledge of international medical standards, coding, and regulatory agencies. The process involves gathering data, modifying it, fact-checking, and review to ensure accuracy and clarity for successful outcomes.
Regulatory translation is the translation of documents for the purpose of meeting the requests of regulatory agencies in particular countries or parts of the world. This type of language translation usually aims to effectively allow the regulatory authorities of a foreign country to review product presentations, so that they can be approved for market uses. This type of high-level translation requires specific skills, as the medical field is a highly technical part of most national economies and the requirements for the international medical trade can be relatively complex.
Those involved in regulatory translation must understand the sophisticated subject matter involved in medical product reviews or similar processes. Some of these require knowledge of international standards for medicine or science in general. In other cases, translators need to understand how to adapt the language of one region to medical standards to the standards of another country or region, where terminology or medical conventions may be substantially different.
Some specific tools can help regulatory translators pursue more effective international presentations for their employers. Knowledge of central source languages, such as Latin, can be helpful, especially since much of modern medical language refers to this classical language. Knowledge of international medical coding can also be helpful. It is often crucial for translators to have a thorough understanding of the regulatory agencies they are preparing to deal with the translated text.
There are also challenges in regulatory translation related to the complexity of regulatory approval documents. These documents can come in many different forms, where spreadsheet documents, advanced graphics, and other types of visuals can complement simple text documents. Common types of regulatory translation documents include risk assessments, technical writings on drugs or medical devices, and general “dossiers” about a product or device.
Some experts describe a dedicated process for regulatory translation. This begins with gathering the appropriate data from the source or sources, then modifying it to achieve the desired pitch. The text can then go through various levels of publication before being presented in the native language of the regulators. Within this process, there will often be a dedicated fact-checking process, or even a supervisory or review process where one person can check another person’s work. This is not only to ensure an accurate translation, but also to pursue clarity in the higher level objectives of the documentation, which is to appeal to the interests of regulators and provide the best chance for a successful outcome.
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