Making a business case for localization is a lot easier today than it may have been in the past. The advantages of winning new customers or satisfying existing ones with products and content provided in their native language are obvious. That so many successful enterprises use localization to generate more than 50 percent of their revenues internationally is an argument that is hard to beat.

When Oscar Wilde quipped in his 1887 short story The Canterville Ghost, “We have really everything in common with America nowadays, except, of course, language,” he was definitely onto something. The differences between British (UK) and American English, however small they appear to non-native speakers, stand out to natives on either side of the pond.

As pharmaceutical innovations become increasingly difficult and expensive to achieve – and as patents expire on blockbuster drugs – generic drug manufacturers have become one of the bright spots in the pharmaceutical industry. By developing "bioequivalent" medicines of original medicines for which patents have expired, these companies bypass many of the costs to bring original innovations to market, shaving 20-90% off the retail price of the drugs they resemble.

It's now two decades since the European Commission established the current regulatory framework for marketing medical devices in Europe. This framework – through the individual directives – has also defined the language and translation requirements for medical device labels.

Translations required as part of the regulatory approval process for medicinal products are, arguably, one of the most exciting areas in the translation industry today. It's a growth area, and while heavily regulated – or perhaps because of this fact – it is in a state of constant flux.

Over the past few years, the amount of translations in the pharmaceutical industry has grown considerably. This has been driven by global regulatory requirements as well as new exciting opportunities that have opened up in new markets, whether for marketing medicinal products or conducting clinical trials. This article reviews some of the current issues in pharmaceutical translations, related to marketing authorization and finding the optimum translation process.