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 it’s heavily regulated — or perhaps because of this fact — it is in a state of constant flux.

Not surprisingly, the majority of the pharmaceutical market across Central and Eastern Europe (CEE), which is estimated to be worth in excess of $63 billion, is occupied by global pharmaceutical companies. This applies to both innovative, patented products, as well as generic products, which constitute over half of the market value.

With the high concentration of organizations that exist in the pharmaceutical industry, leading manufacturers from the United States, the European Union (EU) and Japan have the largest share. However, the CEE pharmaceutical markets are also increasingly targeted by smaller companies. These companies tend to make use of rapid access to these markets as a result of their countries’ membership in the EU.

The Russian pharmaceutical market is a special case. It may constitute some two thirds of the whole CEE pharmaceutical market and has its own specific regulations when it comes to ...