The regulatory environment in Europe is evolving, with significant effort to make regulations – including those governing pharmaceuticals and medical devices – more uniform across the region. Change toward harmonization has come in waves and been characterized by country assimilation into the European Union. Thus, countries can be grouped by their status: the “original” (largely more western) member states, the “new” member states (including Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia), then “candidate” countries (Croatia, Macedonia, Montenegro, Serbia, and Turkey) and potential candidate countries (Albania, Bosnia and Herzegovina, and Kosovo).

While current country-specific trends may vary within and across Eastern Europe (given that each country is moving towards harmonizing with the European Union at a different rate), countries can be grouped based on where they are in their evolution. Regardless, it can be expected that they’re all moving towards a similar goal of harmonized regulations.

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