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History and present

The State Institute for Drug Control (hereinafter referred to as SÚKL or the Institute) is an administrative body of the Czech Republic, an organisational unit of the state and a national competent authority for human medicinal products reporting to the Ministry of Health. The SÚKL´s task is to ensure that only quality, safe and effective medicines, as well as functional and safe medical devices, are used in the Czech Republic. Its activities are regulated by Czech law and international treaties.

History of the Institute

The history of SÚKL goes back to the beginning of the formation of Czechoslovakia as an independent state. The immediate predecessor of today’s Institute was the ‘Institute for Drug Research’, which was established in 1918. The laboratories of this Institute were first located at several departments of Charles University in Prague and from 1931 were concentrated in the National Institute of Public Health (SZÚ), on the premises of which, in buildings 24 and 30, the State Institute for Drug Control is still located today.

SÚKL was separated from the organisational structure of the National Institute of Public Health (SZÚ) by a decree of the Ministry of Health on 24 April 1952. On this occasion, the Institute’s activities were extended to include “the control of medical and diagnostic aids and disinfectants or other”. In 1969, all the Institute’s departments were moved to a new building on the premises of SZÚ No 24.

In 1992, the so-called “drug control laboratories” were included in the Institute to control the operation of pharmacies, to control the handling of medicinal products supplied to hospitals and to control the quality of raw materials supplied to pharmacies by distributors. These laboratories were formerly part of the Pharmacy Service and operated regionally within Regional Institutes of National Health. In the same year, the Institute was assigned the agenda of the approval of medical devices and the assessment of medical devices used in the health sector.

In 1997, by decision of the Minister of Health, this agenda was extended to cover all approval activities relating to all types of medical devices. The scope of the Institute’s activities in the field of pharmaceuticals was refined in 1997 by Act No 79/1997 Coll., on pharmaceuticals. In the area of medical devices, the scope of the Institute’s activities was regulated by Act No 123/2000 Coll. on medical devices, which focused on the Institute’s activities in this area ensuring the safety of devices already on the market. The process of approval of medical devices was transferred to the Ministry of Health of the Czech Republic.

By Act No. 138/2002 Coll., which amended the Act on Advertising Regulation on 1st June 2002, the Institute became the supervisory authority for the supervision of advertising of medicinal products for human use.

With effect from 1st January 2008, Act No. 48/1997 Coll., on Public Health Insurance, the SÚKL was entrusted with setting the maximum prices of medicinal products and determining the amount and conditions of reimbursement of medicinal products. Since the same date, the Institute has been carrying out price control of medicinal products, food for special medical purposes and medical devices.

The activities of the Institute were extended by Act No 296/2008 Coll., on human tissues and cells, which, with effect from 18 October 2008, the Institute was ensuring supervision of the quality and safety of human tissues and cells intended for human use.

The Act No. 167/1998 Coll., on Addictive Substances, extended the supervisory activities of SÚKL to the area of psychotropic substances.

The last change in the scope of the Institute’s activities was brought by the amendment to Act No. 456/2023 Coll. on Medicinal Products, which set new rights and obligations for the entities ensuring the availability of medicinal products for patients in the Czech Republic.

Directors of SÚKL (since 1952):

From 1952 – Prof. PhDr. PhMr. Eduard Skarnitzl
From 1959 – Ing. Jan Buriánek, Csc.
From 1982 – doc. MUDr. Jiří Elis, DrSc.
31.8.1990 – 25.2.1991 temporally assigned as director RNDr. Jan Mikeska, CSc.
From 1991 – doc. RNDr. Jiří Portych, CSc.
From 1993 – RNDr. Jan Mikeska, CSc.
From 1994 – MUDr. Milan Šmíd, CSc.
12.7 2006 – 15.9.2006 temporally assigned as director MUDr. Michal Sojka
16.9.2006 – 31.12.2006 temporally assigned as director RNDr. Jitka Šabartová, CSc.
From 2007 – PharmDr. Martin Beneš
From 2012 – MUDr. Pavel Březovský, MBA
From 2014 – PharmDr. Zdeněk Blahuta
1. 7. 2018 – 20. 9. 2024 Mgr. Irena Storová, MHA
21. 9. 2023 – 20. 12. 2023 Mgr. Kateřina Podrazilová, PhD.
21. 12. 2023 – 30. 4. 2024 temporally assigned as director PharmDr. Jakub Velík, PhD.
From 1. 5. 2024 till now – MUDr. Tomáš Boráň

Contemporary role and activities of the Institute

The State Institute for Drug Control, with its registered office at Šrobárova 48, Prague 100 41, is an administrative body established by Act No. 79/1997 Coll. as organisational unit of the state and a national competent authority for human medicinal products reporting to the Ministry of Health.

The Institute’s scope of activities is established by national legislation.

The Institute establishes regional offices located outside the Institute’s registered office for securing designated tasks within the scope of activities of SÚKL.

The mission of the Institute is, in the interest of protecting the health of citizens:

to ensure that only high quality, effective and safe human medicinal products are available in the Czech Republic,
to ensure that only safe and functional medical devices are used in the Czech Republic, always provided with reliable and relevant information,
to contribute to the rational use of medicinal products and medical devices and, where appropriate, to responsible and ethical clinical trials,
ensure that regulatory measures are applied appropriately preventing unnecessary barriers to the availability of medicinal products and medical devices and during the introduction of new treatments.

The Institute performs the following activities in the Czech Republic:

state supervision over human medicinal products throughout their life-cycle. The Institute is responsible for the monitoring of the quality, efficacy and safety of medicinal products, including accompanying information, at all stages of their development and use. For these purposes, the Institute uses pre-notification, authorisation and registration procedures, inspections, laboratory controls, monitoring the use of medicinal products in practice, supervising the advertising of medicinal products and collecting all relevant information. Since 1 January 2008, the Institute has been carrying out price control of medicinal products, foodstuffs for special medical purposes and medical devices. Since the same date, it has been empowered to decide through administrative procedure about the maximum prices of medicinal products or foodstuffs for special medical purposes and about the amount and conditions of their reimbursement from health insurance.

The Institute is authorised to intervene in the event of health risks, to apply sanctions and to require the necessary documents.

In the field of medical devices, the Institute carries out inspections of healthcare providers, investigation of adverse incidents and clinical trial evaluation.

The scope of the Institute´s competencies in the field of regulation of medicinal products and medical devices is defined by national legislation and international law (see the section on legislation).