State Institute for Drug Control
State Institute for Drug Control (SÚKL) is the Czech Republic's national regulatory authority for pharmaceuticals and medical devices, operating under the Ministry of Health to authorize marketing, set pricing and reimbursement, oversee pharmacovigilance, and combat counterfeit drugs across the Czech market.
- Company typePrivate
- Founded1925
- HeadquartersPraha, Czechia
- Headcount501–1,000
- GTM typeB2B
- OfferingServices
What State Institute for Drug Control does
State Institute for Drug Control (Státní ústav pro kontrolu léčiv, SÚKL) is the Czech Republic's national regulatory authority for medicinal products and medical devices, operating under the Ministry of Health and headquartered in Prague. Established around 1918/1925 and re-constituted following the 1993 dissolution of Czechoslovakia, SÚKL is responsible for marketing authorizations, drug pricing and reimbursement decisions, pharmacovigilance, market surveillance, counterfeit drug detection, and clinical-trial oversight within the Czech market. It coordinates with the European Medicines Agency (EMA), World Health Organization (WHO), European Centre for Disease Prevention and Control (ECDC), and the European Directorate for the Quality of Medicines & HealthCare (EDQM) on European-level evaluations and safety assessments.
SÚKL's technology footprint consists of interconnected digital systems supporting the full regulatory lifecycle: the eRecept electronic prescription platform connecting prescribers and pharmacies nationwide, the ePortál electronic portal for industry submissions, the ISZP medical-device information system integrated with EUDAMED, and a suite of public registers including the drug database, pharmacy database, distributor database, drug availability tracker, and an open data portal. Supporting services include adverse-event reporting systems, RSS feeds, and a public notice board for regulatory announcements.
As a government administrative institution, SÚKL is funded primarily through annual state budget allocations from the Czech Ministry of Health and supplemented by published regulatory fees for registration procedures, clinical trial approvals, pharmacovigilance activities, and other administrative services. Its customer base spans healthcare professionals, the pharmaceutical industry, healthcare facilities, and the general public — all of whom interact with SÚKL through mandatory regulatory processes rather than discretionary purchasing decisions.
State Institute for Drug Control firmographics
Firmographics- Name
- State Institute for Drug Control
- Legal name
- Státní ústav pro kontrolu léčiv
- Website
- https://sukl.gov.cz
- Company type
- Private
- Founded year
- 1925
- Operating status
- Operating
- Headcount range
- 501–1,000 employees
- Short description
- State Institute for Drug Control (SÚKL) is the Czech Republic's national regulatory authority for pharmaceuticals and medical devices, operating under the Ministry of Health to authorize marketing, set pricing and reimbursement, oversee pharmacovigilance, and combat counterfeit drugs across the Czech market.
- Ownership category
- akta.pro rank
Where State Institute for Drug Control is headquartered
LocationHeadquarters
- HQ city
- Praha
- HQ country
- Czechia
- HQ region
- Europe
Offices1 record
Markets served
State Institute for Drug Control business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Infrastructure, Others
Revenue model
- Government Budget Allocation: SÚKL operates as a government regulatory agency funded primarily through annual state budget allocations from the Czech Republic government.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Regulatory service fees |
Distribution channels4 records
Marketing channels9 records
State Institute for Drug Control product offering
Product offeringCore offering
State Institute for Drug Control (SÚKL) is the Czech national regulatory authority for medicinal products, medical devices, and clinical trials. It administers drug registration, price and reimbursement regulation, market surveillance, pharmacovigilance, and counterfeit drug monitoring, and operates a portfolio of interconnected digital systems including the eRecept electronic prescription platform, the ePortál industry portal, multiple public drug and medical device databases, an open data portal, and an adverse drug reaction reporting system.
Product overview
State Institute for Drug Control (SÚKL) is a Czech regulatory authority that operates a portfolio of interconnected digital services organized around pharmaceutical and medical device regulation. The core offering consists of public databases including Databáze léků (Drug Database), Dostupnost léků (Drug Availability Database), Databáze lékáren (Pharmacy Database), Databáze distributorů léčiv (Drug Distributor Database), and Databáze potravin pro zvláštní lékařské účely (PZLÚ Database) — all accessible through the central portal. Key operational systems include eRecept (Electronic Prescription System), ePortál SÚKL (ePortal), and the Informační systém zdravotnických prostředků (Medical Device Information System) connected to EUDAMED. Supporting services include Otevřená data (Open Data Portal) for machine-readable datasets, Seznam hrazených léčivých přípravků (List of Reimbursed Medicinal Products) with price and reimbursement information, Úřední deska (Public Notice Board) for regulatory announcements, and RSS feeds for automated content updates. These systems collectively support the full regulatory lifecycle from drug registration through pharmacovigilance.
Differentiator
Problem solved
Functional benefit
Products and services
- eRecept (Electronic Prescription System)
Companies that use State Institute for Drug Control
Customer profileSegments4 records
Ideal customer profiles4 records
State Institute for Drug Control technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
State Institute for Drug Control partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and minor.
- European Medicines Agency (EMA)coreSÚKL participates in EMA's centralized marketing authorization procedures and contributes to CHMP (Committee for Medicinal Products for Human Use) evaluations. Coordinates European regulatory decisions and safety assessments for the Czech Republic.
- World Health Organization (WHO)coreSÚKL receives counterfeit drug alerts from WHO's Medicrime Convention monitoring system and participates in international pharmacovigilance information exchange.
- European Centre for Disease Prevention and Control (ECDC)coreCollaborates on blood safety surveillance including West Nile Virus transmission risk assessments for blood donor deferral recommendations.
- European Directorate for the Quality of Medicines & HealthCare (EDQM)coreSÚKL participates in European Pharmacopoeia activities, certification of substances, and quality management programs including B-QM blood quality assessment. Facilitates training courses on SoHO quality management.
- EU4Health ProgrammeminorSÚKL participates in EU4Health funded projects supporting pharmaceutical regulatory capacity building and cross-border health initiatives.
Scale indicators1 record
Recent moves6 records
Expansion highlights5 records
State Institute for Drug Control competitors and assessment
Company assessmentBroad incumbents
- European Medicines Agency (EMA): EMA is the EU-wide medicines regulator that runs centralized marketing authorization procedures, and SÚKL directly participates in its CHMP evaluations. EMA is the supranational counterpart and broader incumbent in the same regulatory space.
- U.S. Food and Drug Administration (FDA): FDA is the world's largest national drug and medical device regulator, with FDA-EMA parallel scientific advice frameworks linking it operationally to SÚKL's parent EMA processes. A much larger global incumbent in the same regulatory category.
Direct peers
- French National Agency for the Safety of Medicines and Health Products (ANSM): ANSM is France's national drug and health product safety regulator, with authority over drug authorization, pharmacovigilance, inspections, and pricing decisions. Highly comparable in scope, scale, and regulatory function to SÚKL.
- Spanish Agency of Medicines and Medical Devices (AEMPS): AEMPS regulates medicines, medical devices, cosmetics, and pharmaceuticals in Spain with a similar dual mandate to SÚKL over both products and pricing/reimbursement oversight.
- Swedish Medical Products Agency (Läkemedelsverket): Läkemedelsverket is Sweden's national medicines and medical devices regulator with comparable scope including pharmacovigilance, clinical trials, and market surveillance under EU frameworks.
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED): HALMED is Croatia's national drug and medical device regulator covering marketing authorizations, pharmacovigilance, and pricing. As a smaller Central European EU member state regulator, it is a closely sized peer to SÚKL.
- Medicines and Healthcare products Regulatory Agency (MHRA): MHRA is the UK national medicines and medical devices regulator with statutory authority over drug registration, pharmacovigilance, and inspections. It is the closest functional peer to SÚKL in terms of mandate, scope, and operational structure.
- Danish Medicines Agency (Lægemiddelstyrelsen): Denmark's national medicines regulator with responsibilities over drug authorization, medical devices, and pharmacy oversight — a smaller-state direct peer to SÚKL within the EU regulatory network.
- Italian Medicines Agency (AIFA): AIFA is Italy's national authority for pharmaceuticals, with combined regulatory and pricing/reimbursement responsibilities that closely mirror SÚKL's integrated mandate for the Czech market.
- Federal Institute for Drugs and Medical Devices (BfArM): BfArM is the German federal regulator for medicinal products and medical devices, responsible for marketing authorizations, pharmacovigilance, and risk evaluation. Directly comparable to SÚKL in mandate and EU regulatory participation.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
State Institute for Drug Control social profiles
Digital presenceState Institute for Drug Control financial estimates
Financial estimateRevenue estimate
Valuation estimate
State Institute for Drug Control leadership team
Management profileNumber of profiles
State Institute for Drug Control funding detail
Funding detailFunding overview
Funding rounds
Investors
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State Institute for Drug Control M&A and investment
M&A and investmentM&A
Investments
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Frequently asked questions about State Institute for Drug Control
What does State Institute for Drug Control do?
State Institute for Drug Control (SÚKL) is the Czech national regulatory authority for medicinal products, medical devices, and clinical trials. It administers drug registration, price and reimbursement regulation, market surveillance, pharmacovigilance, and counterfeit drug monitoring, and operates a portfolio of interconnected digital systems including the eRecept electronic prescription platform, the ePortál industry portal, multiple public drug and medical device databases, an open data portal, and an adverse drug reaction reporting system.
Is State Institute for Drug Control a public or private company?
State Institute for Drug Control is a private company. It is classified as state government owned and is currently operating.
When was State Institute for Drug Control founded?
State Institute for Drug Control was founded in 1925. It employs 501 to 1,000 people.
Where is State Institute for Drug Control based?
State Institute for Drug Control is headquartered in Praha, Czechia, in the Europe region.
How does State Institute for Drug Control make money?
One revenue line is on record: government Budget Allocation.
Who are State Institute for Drug Control's main competitors?
Broad incumbents on record are European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). Direct peers are French National Agency for the Safety of Medicines and Health Products (ANSM), Spanish Agency of Medicines and Medical Devices (AEMPS), Swedish Medical Products Agency (Läkemedelsverket), Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Medicines and Healthcare products Regulatory Agency (MHRA), Danish Medicines Agency (Lægemiddelstyrelsen), Italian Medicines Agency (AIFA) and Federal Institute for Drugs and Medical Devices (BfArM).
Does State Institute for Drug Control have an API?
No public API is recorded for State Institute for Drug Control.