Foreign Language Translation
Requirements for Regulatory Compliance

Regulatory Compliance Translation Services

When working with corporate clients to ensure their products comply with regulations around the world, it is essential that one keep in mind the important role of regulatory compliance translation services.  Take, for example, the pharmaceutical sector. When a company brings a new drug to market it must first comply with the regulations of each jurisdiction it intends to sell in. Each jurisdiction has its own regulatory conditions, and more often than not, these regulations will include providing at least some – if not all – information in the local language.

Thus, the most important rule to keep in mind when dealing with regulatory compliance is to never assume that one can use English-language labels in a non-English speaking country. In the European Union, which is a very lucrative market for the pharmaceutical industry, there are numerous regulations requiring foreign language labelling. The Clinical Trials Directive, the Medical Device Directive (MDD) and the In-Vitro Diagnostics Directive (IVDD) each specifically require that all medical labels include a foreign language translation into the language (or languages) of the country in which the product is being tested, distributed or sold.

The problem in complying with such regulations is that, more often than not, these regulations are not issued in English. Thus, attorneys from the US should work with a local legal expert to make sure all the requirements are met. More so, one should always utilize the services of a foreign language legal translation company to ensure proper translation and localization of medical device labeling.

It is also important to see if the regulations require that all foreign language translations be certified as complete and accurate (as is the case in the US).

Needless to say, when launching a global product the required amount of foreign language translations can be extensive. When budgets are tight, it is very often tempting to turn to machine translation programs. However, one should think twice before doing so. Machine translation programs lack the specialized knowledge required in the regulatory arena, and one little error could lead to regulatory and or product and civil liability. As an alternative strategy, consider developing medical labels for each geographic region having similar regulatory compliance requirements. For example, drugs being sold in the US, Canada and Mexico tend to use one standard label containing English, French and Spanish translations. Products being sold in Central Europe will often rely on one label providing the information in French, Dutch and German.

Another strategy for saving money is to foster long-term relationships with your foreign language translation company. Getting a new drug to market is a long enough process and having a bad translation can lead not only to delays but to product recalls and even product liability lawsuits. This risk can be mitigated by working with the same translation company for all the pharmaceutical industry’s regulatory translation requirements.

Up Next: Legal Translation Services
and New ICC Arbitration Rules