Home » What is Regulatory Translation and How Does it Work?

What is Regulatory Translation and How Does it Work?

by Nathan Zachary

Regulatory translation in the medical industry is about the content which may include legal documents and files. Every country has its regulatory authority which allows foreign medical companies to practice in their countries after agreeing to certain factors and rules and regulations. It is a complex field of translation and has its own complexities and technicalities. Therefore, it requires translators with proven experience and subject matter expertise.

What is regulatory translation?

It is a translation that deals with the documentation that requires approval and compliance of medical devices, pharmaceuticals, and medical purposes in the products. Almost every second country now requires the approval of dossiers submitted in the local language from foreign pharmaceutical companies including Japan and the United States. Regulatory bodies of the relevant countries look for this approval form which entails the content in the local and official language of the country. As they have to analyze a lot of factors before finally allowing medical predictions in their country for practice and purchase. Similarly, it is also important that any changes in the approved product, its follow-ups, and any additional issues must be reported in the local language for further consideration and approval.

Basic requirements for the translation                                

Besides linguistics skills, the field of regulatory translation services requires particular training, experience, and subject matter knowledge for the individuals and translators involved in the process of translation. As the regulator content is more about the legal language and jargon which is not easily apprehensible to one and all. To make it understandable for the layman, the translators and team of translation should be vigilant, and experienced and should be understanding the terms exactly. This is important to be vigilant of the fact that regulatory content is technical, sensitive, and contains the regulated nature of medical texts. It also requires adhering to terminology that some countries offer and expect. The companies should conduct relevant and precise research to ensure they understand the regulatory practices of their target audience and are ready to initiate the process.

Formats and patterns required for regulatory content

The translation of regulatory text also asks for particular knowledge of documents, their pattern, and format including being well-versed with the terminology and different patterns of putting up the approval medical dossiers too. As there are different types of documents types within one document of the dossiers. These include CAD drawings, spreadsheets, patients’ signatures in scan form as well as processed expository sections. This process of translation could be challenging and way difficult as compared to other types that medical translation offers.

Examples of regulatory texts

The regulatory texts and medical regulatory documents translation services may include the following documents.

  • Design specification
  • Risk assessments
  • CMC documentation
  • Biocompatibility reports
  • Regulatory approval dossiers
  • Clinical trial documentation
  • Manufacturing procedures for medical devices and drugs
  • Drugs and medical devices usage instructions

Process of translating regulatory content

Translating regulatory data is not a single-step process and neither it can be rushed. It is multi-step and can better be carried out by a translation agency that has proven expertise in the field of overseeing project management and have a good and competent linguistic team.

The steps of the translation for regulatory content may go like

  • Emitting text from the original or source format
  • Translation includes the conversion of the source language text to the target language.
  • Editing – is a very important process of translating regulatory content as minor negligence or mistakes can cause serious and irreversible consequences. Also, it requires proper style and voice.
  • Publishing – in this process translation is sent back into the original format it could be either a word document, web page, or other formats as per the requirement of the clients and companies.
  • Proofreading – like all other domains of translation including medical and veterinary translation, proofreading is also a significant part of regulatory content and translation. It is carried out to ensure that the translation is done in the provided format and it displays correct content in a final arranged document without any ambiguous or corrupted text. It needs proper punctuation and lines and also page numbering is expected to be correct.
  • Final and in-country review – The final step asks for a final review by the native speaker who not only understands the language, and nuances but the industry jargon and is well aware of the terminology as well. As it is extremely important to take care of the laws and regulations when it comes to regulatory content, and medical and veterinary translation services. Any change in text or terms can change the whole meaning and stance of the matter putting the people in court trouble which is not only financially draining but can also endanger overseas business expansion.

Final words

Translation of the regulatory content is not everyone’s cup of tea. It requires a professional translation agency with a competent team of translators, who are well aware of this field of translation and the responsibilities and sensitivities it comes with. It requires translators who are specialized in the field and have relevant subject matter expertise.

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