Slovakia

Regulatory

Under Regulation (EU) No 536/2014, clinical trials in the EU are authorized through the Clinical Trials Information System (CTIS). A sponsor submits one harmonized application via the EU-portal for all intended Member States. The dossier is split into:

• Part I (scientific and technical documentation, common to all CMS)
• Part II (national documents, including ethics requirements)

One Reporting Member State (RMS) coordinates the scientific review, which must be completed within 45 days, with parallel national (Part II) reviews. Requests for information may pause the clock. Each Member State must then issue a decision within 5 days, leading to an overall maximum of 60 days (extensions possible for complex therapies).

The CTR harmonizes approvals across the EU, integrates ethics committees into the process, and ensures transparency through the EU trial database. Since 31 January 2023, all new trials in the EU must follow this system.

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.