Regulatory Translations in Central & Eastern Europe

Pharmaceutical companies marketing in Central and Eastern Europe typically need to deal with three types of countries: EU member states, EU accession countries, and others, such as Russia.

Those which are member states of the EU — the Czech Republic, Bulgaria, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Slovenia — are governed by the regulations of the London-based European Medicines Agency (EMA) or other harmonized regulations.

The EMA has been taking steps to set the stage for the eventual accession of other CEE countries by launching the Instrument for Pre-accession Assistance program back in 2009. Its aim is to support the participation of the beneficiary countries from CEE — Albania, Bosnia-Herzegovina, Croatia, the former Yugoslav Republic of Macedonia, Kosovo (under UNSC Resolution 1244/99), Montenegro, Serbia and Turkey — in the activities of the EMA, in preparation for these countries’ future collaboration in the EU regulatory network.

Russia, for its part, has been developing its own pharmaceutical legislation, which has repercussions for any foreign pharmaceutical company marketing their medicinal products in Russia, conducting clinical trials, or sourcing local production.

This article, published in MultiLingual Computing magazine #126, covers the following:

  • The pharmaceutical industry in CEE
  • The role of the European Medicines Agency (EMA)
  • Russia and the new Russian pharmaceutical legislation
  • Finding medical translators and reviewers in CEE
  • Pre-accession linguistic checking process for Croatian
  • New and potential future EU members from CEE

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