How to overcome the challenges of regulatory translation

Any kind of translation can be challenging. But among the most challenging is medical translation. After all, even a small mistake could put patients’ lives at risk. One of the most difficult aspects of medical and pharma translation is regulatory translation, which combines an ever-present awareness of this risk and a complex amount of guidelines and requirements to fulfill.

What is regulatory translation?

Countries, regions, and even, in some cases, individual organizations have rules regarding medical and pharma translation. It’s not enough to verify the accuracy of a translation; depending on the target audience, a translation must be formatted in a certain way and follow strict rules of terminology.

This not only applies to text, but also to materials that may be included (or are even required to be included), such as charts and drawings.

What type of documents have to follow regulatory translation rules?

Most documents in the medical and pharma fields have to meet specific regulations when they’re translated for different markets. These documents include:

● drug and medical device instructions

● documentation of manufacturing procedures

● clinical trial forms and documentation

● risk assessments

Add to this the requirements of certain regions, like the European Union, where these texts often have to be translated into multiple languages, yet at the same time, as this article points out, translators and their clients must know which country’s laws are the specific ones to follow when it comes to compliance.

What happens if a translation doesn’t comply with regulations?

As with medical and pharma translation in general, incorrect regulatory translations risk harming patients - or even putting their lives in danger.

The author of this article, for instance, gives an example of how a translation mistake for a knee prosthetic resulted in patients experiencing pain and having to have the devices removed and replaced. The company that manufactured the knee replacements suffered in a different way, having to pay compensation to the patients.

In some cases, when translated medical texts are being reviewed by a governing body, even the slightest error will result in the product being blocked or removed from the local market. This is understandable, since it’s a way to protect patients, but still a major setback for pharma companies.

Recently, for instance, the FDA demanded that China-based Guangdong Zhanjiang Jimin Pharmaceutical recall an anti-itch cream from the US market due to a mistranslation of its active ingredient and other compliance issues.

How to ensure that a medical or pharma translation is compliant

Fortunately, translators have some strategies and tools to help them navigate the perilous waters of regulatory translation. These include:

● training. There are a number of courses and certifications available for translators who are working with regulatory translation for the medical field.

● knowledge of markets and compliance guidelines for each target audience. A qualified translator will be familiar with the requirements for compliance for all of the target audiences they’re translating for.

● CAT tools. CAT (Computer-Assisted Translation) tools are where machines and translators meet in the best way possible. Common CAT tools include a translation memory - that is, a sort of glossary of specific terms, which in this case would include any official guidelines and lists of terms set out by authorities in target markets.

● proofreading. Certified translation companies usually rely on the proofreading of translations by a local regulation expert to ensure that they’re compliant.

● experience. The translation team working on regulatory translations should include members who are experienced with regulatory requirements in the target market. aiaTranslations, for instance, is proud of our three decades of experience with medical and pharma translations and our team of highly qualified translators.

Regulatory translation is one of the most difficult aspects of pharma and medical translation. But the right translation provider will combine its team’s training, experience, and knowledge to ensure compliance in any target market.

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Contact Our Writer – Alysa Salzberg