SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
sifies class I medical devices and others as in vitro medical devices.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), thereby promoting regulatory alignment. To enhance transparency, the ALIMS publishes infor- mation on approved clinical trials on its official web- site. Overall, the current regulatory framework reflects a more harmonised and efficiency-oriented approach, aimed at improving Serbia’s attractiveness as a des- tination for clinical research. Clinical Trials for Medical Devices The Medical Devices Act and the Rulebook on Clini- cal Trials for Medical Devices of 2018 (as amended) regulate clinical trials for medical devices. Clinical trials of medical devices are conducted in accordance with the guidelines of the Good Clinical Practice. 2.2 Securing Authorisation to Undertake a Clinical Trial Clinical Trials Subject to Approval Sponsors must request simultaneous authorisations for conducting a clinical trial from the ALIMS and the Ethics Committee of Serbia, a government-appoint- ed expert body that takes care of the provision and implementation of healthcare at the national level, in the case of: • clinical trials for medicines which do not have a marketing authorisation or for which a different use from the one prescribed in the approved summary of product characteristics is proposed, or medical devices for which a conformity assessment has not been carried out; and • an interventional post-marketing clinical trial, where the medicinal product is applied in accordance with the conditions prescribed in the marketing authorisation, but requires additional diagnostic procedures, as well as the monitoring procedures defined by the clinical trial protocol, or where a medical device has been subject to conformity assessment, but the clinical trial is conducted for a purpose that is absent from the conformity assess- ment.
2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical Trials for Pharmaceuticals
The Medicines Act is the principal piece of legislation regulating clinical trials of pharmaceuticals. Addition- ally, the Healthcare Act of 2019 and the Rulebook on Clinical Trials for Medicines for Human Use (2022, as amended in 2023 and 2024), set out detailed rules related to ethics committee approval and performance of clinical trials. Clinical trials of pharmaceuticals are conducted in accordance with the Ministry of Health’s guidelines on Good Manufacturing Practice (2017), Good Laboratory Practice (2008) and Good Clinical Practice (2017). Under the current Clinical Trials Rulebook, Serbia provides a more open and facilitative framework for the conduct of clinical trials across all development phases. Both public and private healthcare institutions may conduct phase I (including Ia and Ib), phase II and phase III clinical trials, provided that they meet the prescribed requirements. There is no longer a phase- based restriction limiting early-phase trials only to public healthcare institutions. This broader eligibility is expected to strengthen Serbia’s competitiveness in attracting early-stage clinical research. The regulatory framework no longer imposes a for- mal requirement that principal investigators must have prior clinical trial experience. Instead, investigators must meet the general professional, ethical and com- petency standards applicable under Serbian law and good clinical practice (GCP) requirements. From a procedural perspective, the approval process has been streamlined. Import authorisation for investi- gational medicinal products is granted simultaneously with the clinical trial approval, reducing administrative burden and timelines for sponsors. When reviewing clinical trial applications, the ALIMS takes into con- sideration relevant decisions, opinions and guidance issued by the European Medicines Agency (EMA) and other internationally recognised bodies, including the
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