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5 Important Don’ts of Regulatory Translation

by Steven Brown
Regulatory Translation

Medical content and translation include a lot of complex and tough content. Even a single bottle of prescription contains various information types on it including dosage and frequency for use, storage instructions, its side effects, and warnings. These all details are often depicted in more than one language. The distribution setup of drugs and devices across borders has compelled the makers to translate the packaging and labels as a value-added service. Also, they have made it highly regulated and a practice that is carried out more often. This is why translation services in the pharmaceutical industry require extremely professional and competent people.

Considering the importance and significance of the translation and its content there are particular tips that should be followed while conducting the translation services for regulatory compliance and other medical device translation. The companies should ensure they don’t indulge in the below-mentioned practices.

1. Do not use the English language for all the labels

People often assume English is one of the most spoken languages and also suppose that it is the one that people all over the world can speak and understand. However, this is not the case. English is undoubtedly a universal language and one of the most popular languages but there are a lot more that are even more important languages and countries in Europe prefer their languages over English. Therefore, it is imperative to translate the medical content and regulatory text into the required languages so that people know what they are consuming.

2. Do not hire a new or incompetent translation company

A consultant can only look through the regulatory translation if he is well familiar with the labeling and packaging regulations in a foreign country. It also includes having knowledge of compliance issues and providing extra and expert guidance to the translators so that they can translate the content professionally and can deliver a quality product. It is vital to hire an experienced translation agency to perform a seamless process. Drug manufacturers and medical device companies have to perform tests for their drugs or market the products all over the world. They all have to meet the regulatory requirements set by the relevant country. It includes translation, design, and content of the labels as well as instructions for use.

The European Union has particularly issued a lot of directives that regulate the CE mark and is also required to distribute medical and other diagnostic devices. Also, medical companies should ensure that while hiring translation services they take care of foreign language labeling accuracy. This is all possible when the translation company understands its job well.

3. Do not use machine translation

Regulatory compliance translation is a highly technical and sensitive area. The translation, therefore, has to be error-free and without much hassle which further defines how labeling and instructional use should be accurate and authentic. Errors and mistakes may lead to null regulatory products or civil liabilities. Therefore, professional translators and translation agency is a must. Using machine translation may lead to worst scenarios. Machine translation can barely understand the context and also doesn’t deliver accurate translation services. The experience and subject matter expertise can only be delivered by professional translators who have relevant expertise. Machine tools though can help translators in producing better content however alone they can’t deliver a precise translation.

4. Do not consider the same regulatory requirements for all regions

The medical companies and the people who are involved in pharmaceutical translation services should ensure that they understand the differences in the regulatory content which are different in the different regions. The regions keep working and developing new pharmaceutical and medical device regulations. However, producing the content in one language and copying it for every region and country could lead to chaos. Therefore, it is important that professional and up-to-date translation services are used to translate this content in a possible manner. An example may include countries NAFTA (United States, Mexico, and Canada) the FDA-approved drugs can be marketed in the languages such as English, French and Spanish languages. Though most of the regulatory requirements are similar, it is important to go through these before starting the work.

5. Do not ignore the need of assigning a contact person

Businesses and medical companies should realize the responsibilities and work that come with medical translation services. Also, they should make sure they assign a person from their team who can take care of the translation projects and can stay in touch with the translation firm. They can always check on him whenever they need to get an update about professional pharmaceutical translation services and translational projects and their execution. The translation company should also make sure that they communicate with the assigned contact person on regular basis updating them with all important happenings.

Final words

Translating regulatory content is a tough deal. Medical companies, as well as translation agencies, should make sure they know the process and during this complicated operation, they don’t overlook particular facts and follow certain practices to produce good content and avoid the things which may lead to quality issues producing inaccurate or poor translation content.

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