Currently the SAM is an agency under the Ministry of Social Affairs. The SAM has 6 departments and over 90 employees. Our main office is in Tartu, but there is an office in Tallinn as well. The Director General of the SAM is Katrin Kiisk.
The State Agency of Medicines (SAM) is a governmental body with the aim to
- ensure that medicines approved for use in Estonia for the prevention, treatment and diagnosis of human and animal diseases are proven to be efficacious, of high quality and safe;
- promote the rational use of medicines;
- ensure the protection of the safety and rights of the clinical trial participants in Estonia;
- ensure that cells, tissues and organs used in the treatment of humans in Estonia are proven to be safe and of high quality;
- ensure that narcotic and psychotropic substances and their precursors are used appropriately and in accordance with international conventions.
Mission of the State Agency of Medicines
The mission of the State Agency of Medicines is to protect human and animal health through the supervision of medicines and biological products used in Estonia, to support rational use of medicines and to contribute to the development of pharmaceutical research and entrepreneurship.
Vision of the State Agency of Medicines
Safe, high-quality and efficacious medicines are used and available in Estonia. The State Agency of Medicines is the most qualified professional body in the field of medicines in Estonia, a reliable partner in the medicines sector in Estonia and to international colleagues, and a valued employer.
Values of the State Agency of Medicines
- We base our work on relevant scientific data and legislation and use the best expertise available in Estonia.
- We constantly update our knowledge and operating methods.
- We are aware that our every action reflects on the State Agency of Medicines and remember that our decisions have a significant impact.
- We consider all known aspects when making decisions and we are impartial towards our partners and colleagues.
- We look for substantive solutions and keep our promises.
- We analyze our decisions, admit our mistakes and learn from them.
- We actively identify the areas in which we can be of assistance.
- We have a say in important discussions and initiate necessary changes.
- We value our own, our colleagues’ and our partners’ time.
- We complete what we start.
- We guide ourselves by the main purpose of the State Agency of Medicines to protect public health while contributing to the development of research and entrepreneurship in Estonia with our knowledge.
- We recognise opportunities for cooperation and are open to relevant suggestions.
- We value the expectations of our cooperation partners and adhere to agreements.
The main vision for 2023 of the Agency is a competent and effective agency providing medicines related information and support in an appropriate and convenient manner.
Priority development areas and goals of the Agency in 2019–2022:
- By 2022, have at least five innovative digital services and a plan for further development.
- We have undertaken to assess three MA applications for biotechnological medicines and review applications for clinical trials using the common EU-wide procedure. We have developed expertise to give scientific advice on biological, biotechnological, and innovative drugs as well as novel health technologies.
- We have become the main centre of drug information for the general public and stakeholders, and by 2022 we provide information in a more user-friendly manner.
- We only collect and process information that can be used for the benefit of public health. We only engage in activities that are essential and contribute to the protection of public health. We know which regulations should be worded more clearly and which should provide a wider margin for discretion. Our workload is distributed more evenly and staff members have time available for self-development.
The full text of the Development Strategy
Quality Management System
Our quality management system is committed to the implementation and maintenance of a documented quality management system which is continually improved. The system is based on the requirements of the legislation, the regulatory system and ISO 9001; it also takes into account guidelines, standards and best practices from Estonian and international organizations.
The quality system is implemented and operated by all agency`s staff. Internal audits help to provide quality assurance to management that the system is operating effectively, and contributes to the improvement of systems and processes.
The Heads of the European Medicines Agencies have established a benchmarking exercise, the aim of which is to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to the best practice standards.
The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment in four areas: organization and management; assessment of marketing authorization applications; pharmacovigilance and inspections. The internal self-assessments are then followed up by external peer-reviews. Reports from all the visited agencies are entered into a database which forms a valuable resource for best practice across the entire EU/EEA network of medicines agencies.
Our laboratory is accredited according to the EVS-EN ISO/IEC 17025:2017 by the Estonian Accreditation Centre (accreditation certificate no L217.) The Scope of the accreditation is given in the annex to the accreditation certificate.
Last updated: 23.11.2021