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
The Agency employs the best internationally recognised experts whose expertise, skills and values contribute to the development of the pharmaceutical sector as well as pharmaceutical awareness.
Values of the State Agency of Medicines
Competence
- 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.
Reliability
- 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.
Efficiency
- 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.
Cooperation
- 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.
Development Strategy
The main vision for 2026 The Agency employs the best internationally recognised experts whose expertise, skills and values contribute to
the development of the pharmaceutical sector as well as pharmaceutical awareness.
Priority development areas and goals of the Agency in 2023–2026:
- Drug information providing added value
- We improve public awareness of the Agency as a source of reliable drug information, and know what information various stakeholders need
- We improve patients’ drug-awareness, and thereby their engagement in the treatment process
- nformation on clinical trials and trial sites is available to potential subjects as well as doctors
- Being an innovative and valued partner
- Strengthening the advisory aspect of supervision
- Improving scientific advisory capability
- Proposals to update regulations and provide room for discretion on the European Union level as well as in Estonia.
- Long-term state capability for directing and developing the pharmaceutical field
- Attractiveness as an employer
- Efficient organisation of work, potential replacements for all roles
- Developing environmental awareness in the Agency
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.
Benchmarking
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.
OMCL
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: 25.05.2023