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Robust Pharma Regulatory Fundamentals in Slovakia

The regulatory requirements in emerging CEE markets remain challenging for the pharmaceutical and medical device manufacturers alike. Slovakia has earned the reputation of a country with the advanced regulatory environment and well-developed operating systems. As a testimony, Bratislava emerged as a strong candidate in the race to host the headquarters of the European Medicines Agency (EMA).

Whilst the Slovak Republic is facing the same health outcome challenges as its eastern European neighbours, it has a distinctively higher level of per capita expenditure on innovative high-value medicinal products. Furthermore, at 22% the market value share of generic products is one of the lowest in the region. For comparison, generic pharmaceuticals account for 62% of the market in Poland and 38% in Hungary.

According to EFPIA data, in 2015 Slovakian payment for pharmaceuticals by compulsory health insurance systems and national health services (ambulatory care only) was estimated at €1,089mn. With population of 5.4mn people, this figure stands in stark contrast to expenditure of €1,153mn in Romania with almost 20mn inhabitants.

Slovakia maintains the position of the fastest growing economies in the European Union with the forecast 3.3% GDP growth in 2017. Strong economic performance underpins the stability and growth of the domestic pharmaceutical market. Slovakia will continue to attract interest and investment of pharmaceutical and medical device companies, innovative players in the first hand, as it proved to have one of the most robust regulatory environments in the region.

For further information regarding regulatory submissions, MA approval and national authorisation procedures in Central and Eastern Europe, please contact Klaus Doring at Grove Group Pharmaservices klausdoring@groveonline.com or visit our website www.groveonline.com