State Institute for Drug Control

What State Institute for Drug Control does

Státní ústav pro kontrolu léčiv (State Institute for Drug Control, SÚKL) is the Czech Republic's statutory regulatory authority for medicinal products, medical devices, and human tissues, operating under the supervision of the Ministry of Health. Founded in 1925 and headquartered at Šrobárova 49/48, Prague 10, the institute employs 133 staff and discharges exclusive national responsibilities for drug registration, market authorization, pricing and reimbursement regulation from public health insurance, inspection of pharmaceutical manufacturers and distributors, pharmacovigilance, and counterfeit/quality-defect surveillance. SÚKL is a member of the European medicines regulatory network, collaborating with the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), and the European Commission on EU4Health projects, and contributes to the EUDAMED European database for medical devices.

The institute's core technological assets are a suite of regulatory information systems: the Drug Database and Drug Availability Database (Databáze léků and Dostupnosti léků), the Medical Device Information System (ISZP), pharmacy and distributor databases, and the Foods for Special Medical Purposes database. The mandatory national eRecept electronic prescription system and the ePortál SÚKL submission portal together form the operational backbone of pharmaceutical regulation in the Czech Republic, while an Open Data portal publishes structured datasets (XLS/CSV/TXT) for public and industry consumption. Supporting functions include a 24/7 drug quality-defect hotline, a medical-device vigilance service, and the Adverse Drug Reaction Reporting System. The official Věstník SÚKL bulletin carries regulatory announcements, safety warnings, and recalls.

SÚKL's funding model is dual-track: state budget appropriations from the Ministry of Health cover its public mandate, while administrative regulatory fees collected for drug registration, market authorization, inspections, and pharmacovigilance activities supplement this funding. The fee schedule is published publicly. Because SÚKL is a government regulatory body, it does not pursue commercial monetization or expansion beyond its statutory remit; its "go-to-market" is universal and mandatory for all pharmaceutical and medical device market participants in the Czech Republic, and its communications channels span the official website, ePortál, bulletin, RSS feeds, social media, press relations, and recurring educational seminars.

Name

State Institute for Drug Control

Legal name

Státní ústav pro kontrolu léčiv

Website

https://sukl.cz

Company type

Private

Founded year

1925

Operating status

Operating

Headcount range

101–250 employees

Short description

SÚKL (State Institute for Drug Control) is the Czech Republic's statutory regulator for pharmaceuticals, medical devices, and human tissues, serving the public, healthcare professionals, and industry through drug registration, pricing/reimbursement, pharmacovigilance, and national systems including eRecept.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulation

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)

akta.pro industry

PRIMARYHLAJADAA

Drug Regulators (Human Pharmaceuticals)

Healthcare & Life Sciences/Public Health, Government & Regulators/Medicines & Healthcare Product Regulators (Drugs/Biologics/Devices)

SECONDARYHLAJACAI

Controlled Substances & Pharmacy Regulation Authorities

Healthcare & Life Sciences/Public Health, Government & Regulators/Health Policy, Regulation & Compliance Authorities

Keywords

• Pharmaceutical regulation
• Drug registration
• Pharmacovigilance services
• Medical device oversight
• Drug pricing reimbursement

Headquarters

HQ city

Prague

HQ country

Czechia

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Others

Revenue model

1. Regulatory Fees and Administrative Charges: SÚKL collects administrative fees for regulatory services including drug registration, market authorization, inspection services, and pharmacovigilance activities. Fee schedules are published in the Sazebník a poplatky (fee schedule) section.
2. State Budget Funding: As a Czech state regulatory body, SÚKL receives funding through the state budget as part of its mandate to protect public health and regulate pharmaceutical markets.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

SÚKL is the Czech state regulatory authority that performs drug registration and market authorization, sets prices and reimbursement levels for medicines covered by public health insurance, conducts pharmacovigilance and adverse drug reaction monitoring, regulates pharmacies and drug distributors, and oversees medical devices. It operates national information systems including the eRecept electronic prescription platform, ePortál regulatory submission portal, and multiple public databases of medicines, pharmacies, and distributors.

Product overview

State Institute for Drug Control (SÚKL) operates a comprehensive portfolio of regulatory information systems and databases as a Czech government regulatory agency. The core offerings include the Drug Database, Drug Availability Database, and Database of Foods for Special Medical Purposes for public reference; the Medical Device Information System and Medical Device Register for device regulation; and the Pharmacy and Distributor databases for supply chain oversight. SÚKL also maintains the national eRecept electronic prescription system and the ePortál portal for industry submissions and regulatory procedures. Price and Reimbursement Lists are published monthly, along with the Věstník SÚKL bulletin for regulatory announcements. The Open Data service provides structured datasets, and SÚKL participates in the EUDAMED European medical device database. Adverse reaction and quality defect reporting systems support pharmacovigilance and market surveillance functions.

Differentiator

Problem solved

Functional benefit

Products and services

• Drug Database (Databáze léků) A comprehensive searchable database of registered medicinal products available in the Czech Republic, providing pharmaceutical product information, composition, and registration details to healthcare professionals and the public.
• Drug Availability Database (Databáze dostupnosti léků) A database tracking the availability status of medicinal products in the Czech Republic, including information on supply shortages and discontinuations.
• Medical Device Information System (ISZP) An information system managing data on medical devices, including registrations, certifications, and market surveillance information for the Czech Republic.
• eRecept (Electronic Prescription System) The Czech Republic's national electronic prescription system enabling healthcare providers to issue, manage, and dispense digital prescriptions for medicinal products.
• ePortál SÚKL An electronic portal providing pharmaceutical industry stakeholders with secure access to regulatory submissions, administrative procedures, and official communications with SÚKL.
• Price and Reimbursement Lists (Seznam cen a úhrad LP/PZLÚ) Official monthly publications containing price and reimbursement information for medicinal products and foods for special medical purposes covered by Czech public health insurance.
• Medical Device Register A register of medical devices including registration, notification, and certification data, connected to the EUDAMED European database for cross-border market surveillance.
• Open Data Portal (Otevřená data) Open data services providing downloadable datasets of pharmaceutical prices, reimbursement information, drug availability, and other regulatory data in structured formats (XLS, CSV, TXT).
• Věstník SÚKL (SÚKL Bulletin) An official periodic bulletin containing regulatory announcements, safety warnings, quality defect notifications, drug recalls, and availability updates for medicinal products and medical devices.
• Adverse Drug Reaction Reporting System A reporting system enabling healthcare professionals and patients to report suspected adverse drug reactions to SÚKL for pharmacovigilance and safety monitoring purposes.
• Drug Quality Defect and Counterfeit Reporting System A reporting system for identifying and tracking quality defects, counterfeits, and recalled pharmaceutical products in the Czech pharmaceutical supply chain, supported by 24/7 service.
• Pharmacy Database (Databáze lékáren) A searchable database of licensed pharmacies operating in the Czech Republic, supporting supply chain oversight and public access to pharmacy information.
• Drug Distributor Database (Databáze distributorů léčiv) A searchable database of authorized drug distributors in the Czech Republic, supporting distribution licensing oversight and supply chain regulation.

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core.

• European Medicines Agency (EMA)coreTechnology or IntegrationSÚKL collaborates with EMA on European pharmacovigilance, drug review processes, and regulatory harmonization under EU pharmaceutical legislation.
• European Directorate for the Quality of Medicines & HealthCare (EDQM)coreStrategic or Co-development PartnerCollaboration on European Pharmacopoeia, certification of substances, and quality standards for medicines. SÚKL participates in EDQM programs including the Blood Quality Management (B-QM) program.
• European Commission - EU4Health ProgrammecoreStrategic or Co-development PartnerSÚKL participates in EU4Health funded projects for pharmaceutical regulation, public health improvement, and cross-border health cooperation.
• Ministry of Health of the Czech RepubliccoreStrategic or Co-development PartnerSÚKL operates under the supervision of the Ministry of Health and implements national pharmaceutical policy, pricing regulations, and health technology assessment.
• Czech Health Insurance CompaniescoreStrategic or Co-development PartnerSÚKL determines drug prices and reimbursement levels covered by public health insurance in collaboration with health insurance funds.
• Healthcare Providers and HospitalscoreStrategic or Co-development PartnerSÚKL oversees clinical trials, hemovigilance, and adverse event reporting in collaboration with healthcare facilities across the Czech Republic.
• National Pharmacists Chamber (Česká lékárnická komora)coreStrategic or Co-development PartnerCollaboration on pharmacy regulation, dispensing standards, and pharmaceutical care quality.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MHRA (Medicines and Healthcare products Regulatory Agency): UK regulator for medicines, medical devices, and blood components; shares SÚKL's end-to-end regulatory mandate (registration, pharmacovigilance, devices) and operates comparable national databases and reporting systems.
• ŠÚKL (State Institute for Drug Control, Slovakia): Slovakia's national drug regulator; near-identical name and scope to SÚKL, covering drug registration, pricing, and market surveillance in a similarly sized Central European market — the closest functional twin.
• BfArM (Federal Institute for Drugs and Medical Devices): Germany's federal regulator for medicines and medical devices; directly comparable to SÚKL in scope (drug and device regulation) and function (registration, pharmacovigilance, pricing support), making it the most analogous national peer.
• ANSM (Agence nationale de sécurité du médicament): France's national medicines agency responsible for drug safety, regulation, and inspection; highly comparable in mandate and operational model to SÚKL, though at significantly larger scale.
• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): Spain's national regulator for medicines and medical devices; structurally and functionally aligned with SÚKL across drug registration, surveillance, and pricing/reimbursement functions.
• OGYÉI (National Institute of Pharmacy and Nutrition): Hungary's national pharmaceutical and nutrition regulatory authority; comparable in mandate (drug authorization, pharmacovigilance, medical device oversight) and in operating within a similarly sized EU member state market.
• HALMED (Agency for Medicinal Products and Medical Devices, Croatia): Croatia's national regulator for medicines and medical devices; structurally analogous to SÚKL as a small EU-member-state agency covering registration, vigilance, and device oversight.
• URPL (Office for Registration of Medicinal Products, Poland): Poland's national drug registration authority; covers drug registration and pharmacovigilance, comparable to SÚKL though with narrower scope (registration rather than pricing/reimbursement).

Broad incumbents

• European Medicines Agency (EMA): EU-level regulatory authority for human and veterinary medicines; SÚKL is a national counterpart that collaborates with EMA on pharmacovigilance, drug review, and regulatory harmonization, making EMA the closest supra-national peer.

Others

• EDQM (European Directorate for the Quality of Medicines & HealthCare): Council of Europe body that sets quality standards for medicines and runs the Blood Quality Management programme in which SÚKL participates; comparable as a peer organization in pharmaceutical quality oversight rather than a direct competitor.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/suklcz
• YouTubeyoutube.com/@statniustavprokontroluleciv
• Facebookfacebook.com/statniustavprokontroluleciv
• LinkedInlinkedin.com/company/state-institute-for-drug-control
• Instagraminstagram.com/suklcz

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about State Institute for Drug Control