Clinical trials

Clinical trials of medicinal products is every testing on humans with the aim to: find or confirm clinical, pharmacological and/or pharmacodynamic effects of one or more medicinal products which is being tested; detect adverse effects on one or more medicinal products, as well as the clinical part of testing of bioequivalence and bioavailability of one or more medicinal products for the purpose of confirming safety and efficacy of the medicinal product(s). Clinical testing should be conducted in accordance with ethical principles derived from the Helsinki Declaration, according to the guidelines of Good clinical practice, International Conference on Harmonization and other valid regulations.

Medicinal products are clinically tested after performed pharmacological and pharmaco-toxicological testing, in accordance with ethic principles and obligatory protection of personal data of persons which are participating in clinical trials. Medicinal products which are used in clinical trials have to be manufactured in accordance with the guidelines of Good clinical practice and labelled as “for clinical trials”.

Committee for clinical trials is an independent, advisory body, whose duty is to give assessment of validity of clinical trials, as well as to assess compatibility of clinical trials with the Good clinical practice, to ensure and protect rights, safety and wellbeing of examinees in clinical trials and creating possibilities for fast and financially available innovative therapy. Applications for permission to conduct clinical testing and the registration of clinical testing are processed by experts from the Committee and the Agency, and the decision is issued in accordance with the Directives 2001/20/EC and 2005/28/EC. The Agency for medicinal products and medical devices of Bosnia and Herzegovina supervises the pursuit of clinical trials in accordance with the Act of medicinal products and medical devices of B-H (“Official Gazette of B-H, no.58/08”), with the Regulations of clinical trials of medicinal products and medical devices (“Official Gazette of B-H, no.4/10”) and with the guidelines of Good Clinical Practice in clinical trials. The proposer of clinical trials of medicinal product may demand from the Agency to control clinical trials of medicinal product in places where clinical trial is conducted. The Agency may stop or ban a clinical trial of medicinal product while controlling the pursuit of clinical trials.

The import of medicinal products, medical devices and biological materials for clinical trials comes within the jurisdiction of entity ministries, namely the Ministry of Health and Social Welfare of Republic of Srpska, the Ministry of Health of Federation of B-H and the Department of Health of Brcko District and other services of the Government of Brcko District.