The State Institute for Drug Control (SIDC) is the institution of the state authority in the field of human pharmacy and drug precursors. The SIDC is headed by a director, who is appointed and dismissed by the Minister of Health of the Slovak Republic.
In accordance with the law, SIDC among other activities, has the following responsibilities:
- ensures activities associated with marketing authorization and with an availability of effective and safe medicinal products
- processes applications for clinical trials and approval of clinical trials
- controls and evaluates the process of assessing the quality, efficacy and safety of drugs
- issues authorizations for treatment for drug precursors
- collects, monitors and analyzes of suspected adverse drug reactions,
- processes notifications from rapid alert in suspicion on quality defect of the medicinal products
- carries out control activities and standardized laboratory activities in assessing the quality, effectiveness and safety of human drugs
- performs inspections of Good clinical practise, Good pharmacovigilance practise, Good manufacturing practice, Good distribution practice, Good Pharmacy Practice and Good preparation practice for blood products
- controls, standardizes and evaluates the process of assessing the quality, efficacy and safety of medical devices
- prepares and issues a Slovak Pharmaceutical Codex and cooperates on preparing the European Pharmacopoeia
- controls advertisement of medicinal products in the print media and on the website
- cooperates with state authorities in suspicion for falsification of medicinal products
- monitors and analyzes data on exports of medicinal products from the Slovak Republic
- performs withdrawal or suspension of marketing or marketing authorization of medicinal products or medical devices
- keeps database of authorized drugs and medical devices
Other professional activities of the employees of the State Institute for Drug Control
Employees of the SIDC, besides the active participation in the meetings of the commissions, working groups and committees within the framework of international cooperation, also participate as lecturers in domestic professional seminars and conferences. They regularly present scientific information in the form of publications and they participate in the proposal of related legislation, technical material for professionals and general public.
Advisory bodies
Within the expertise process in the evaluation of efficacy, quality and safety of medicines, SIDC collaborates with experts from the Faculty of Pharmacy of Comenius University, Faculty of Medicine of Slovak Medical University and experts from relevant fields of medicine.
External experts participate as members of the advisory bodies (Committee for medicinal products, Subcommittee for generic medicine, Committee for drug safety, Pharmacopoeia committee, Committee for advertising, Subcommitee for phytotherapeutics and homeopatics, Committee for drug quality, Ethics committee of the regional government) of the SIDC.
External experts contribute to the development of expert evaluation reports related to the examination of the application for clinical trials and the efficacy, safety and quality of medicinal products. They are also involved in the development of guidelines and standard requirements in drug policy within the scope of the SIDC.
The SIDC regularly communicates with professional organisations such as Slovak Chamber of Pharmacists, Slovak Medical Chamber and with patient organisations.
International cooperation
The SIDC also cooperates with foreign institutions within the Council of Europe and with the European Pharmacopoeia Commission. SIDC also cooperates within the European Network of pharmaceutical activities in the field of quality of the medicinal products.
The SIDC maintains and develops bilateral contacts with the European Commission and other medicine agencies, which are the assumption of its effective functioning as the competent authority in the Slovak Republic.
The SIDC is through the Laboratory Control Section connected to a network of European laboratories for drug control.
Cooperation in the implementation of the European Pharmacopoeia (Ph.Eur.) in the procedures of national entities, membership in the European Pharmacopoeia Commission and active involvement in the EDQM in the field of reference substances also contribute to the recognition of the state constitution as the national authority for human pharmaceutics.
The SIDC is also involved in benchmarking (BEMA). Within the BEMA, the SIDC is regularly subjected to international inspections to assess systems and processes of the medicines agencies in order to ensure a standard level of services provided medicines agencies in the EU.
