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Clinical Trials
The Agency shall supervise the conduct of a clinical trial with the provisions of this Law, regulations passed in accordance with this Law andwith regard to requirementsof the Guidelines for Good Clinical Practice in Clinical Trials.
The clinical trials applicant shall be entitled to request the Agency to perform an inspection of the clinical trials of the medicinal product in institutions where clinical trials are performed.
Medicines and Medical Devices Agency of Serbia issues the Authorisations for Clinical Trials too, to the manufacturers of innovative medicines and devices whose companies are registered outside Serbia. The aplications usualy concern the III a. and b. and IV phase of clinical trials, i.e. for medicines and devices in development phase, and medicines and devices already marketed. The documentation is assessed by the experts employed at the Agency or independent experts advisers to the Agency. The Committee for clinical trials assessment for medicines and medical devices for use in human medicine reviews the documentation and expert reports and advises the Agency on clinical trials authorising in compliance with EU Directive 2001/20/EC. Auditing of authorised clinical trials is performed in compliance with the Directive and ICH guidelines.
In authorising clinical trials a very thorough and highly professional assessment of the requested study is done to assure safety of patients involved and when it is possible to provide conditions for timely and financially accessible inovative therapy for a number of patients that would otherwise not have accessibility to such a treatment.