Slovakia

Regulatory

In the Slovak Republic, the main regulatory authority over medicinal products, devices, and biologicals is the State Institute for Drug Control (SUKL or SIDC) under the Ministry of Health.

Clinical trials require the approval of both the SUKL and the respective Ethics Committee.

The SUKL cooperates with foreign institutions, within the Council of Europe and with the European Pharmacopoeia Commission, within the European Network of pharmaceutical activities in the field of quality of medicinal products.

Official links

https://www.sukl.sk/

Pharmaceutical Industry & Clinical Trials Market

Slovakia is one of the most developed health device and pharmaceutical markets in the Central and Eastern European region.

Slovakia’s medical device manufacturing sector has a long history, particularly in the area of orthopedic and dental equipment. At present, Slovak companies largely produce single-use medical equipment. Domestic medical device production is estimated to be in excess of $300 million.

Medical System in Slovakia

Slovakia has a public healthcare system, as well as a small private sector. There are 44 state hospitals within the country. Citizens can choose between three nationwide health insurance companies; one is private while the other two are public.

In 2018, the Slovakian government created the public eHealth initiative to improve technology within hospitals and create electronic medical records. This reform included the introduction of an electronic health book of a patient, the possibility of prescribing and dispensing the medicinal products and medicinal devices via electronic means.