SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
Implementing by-laws which regulate applica- tions for marketing authorisations, as well as the approval of variations, need urgent amendments in order to remove unnecessary administrative barriers and further expand the use of reliance procedure in approval of marketing authorisa- tions and post-approval changes. Recent amendments to the clinical trial regulation In 2023 and 2024 there were turbulent regu- latory changes in the clinical trials sector. In August 2023, the government introduced strin- gent amendments to the Clinical Trials Rule- book, which were largely reversed in October due to the outcry from the industry. Nonethe- less, restrictions remained on Phase I (Ia and Ib) clinical trials, limiting them to public healthcare institutions. A new requirement was also intro- duced, stipulating that chief investigators must be full-time employees of a healthcare institu- tion, except for those serving as professors at higher education institutions. Following a continued discussion between the government and the industry, further amend- ments to the Clinical Trials Rulebook were made in December 2024, lifting the restriction on private healthcare institutions, allowing them to conduct Phase I trials in addition to Phases II and III. The requirement for prior clinical trial experience for principal investigators was also removed. Additionally, import approval for medi- cines subject to clinical trial will now be grant- ed simultaneously with clinical trial approval, streamlining the process. To improve efficiency, the Medicines and Medical Devices Agency of Serbia (ALIMS) will take into account decisions from the European Medicines Agency (EMA) and other international regulatory bodies, such as the International Council for Harmonisation (ICH), when reviewing clinical trial applications. ALIMS
will also publish information on all approved clin- ical trials to enhance transparency. Efforts to Expedite Regulatory Procedures ALIMS is significantly behind the legally pre- scribed deadlines for issuing, renewing and amending marketing authorisations for medi- cines, as well as approving promotional materi- als. These delays result in longer patient wait times for new therapies, disruptions in the con- tinuity of medicine supply, and additional costs due to failed procurement processes. ALIMS struggles with prolonged timelines for review- ing applications, exceeding legally prescribed deadlines. Limited administrative capacity and unclear regulatory interpretations contribute to bottlenecks, making it difficult for manufactur- ers to plan supply chains efficiently. Companies operating in Serbia frequently face inconsistent requirements compared to EU markets, further complicating compliance. In 2024, ALIMS made progress in streamlining the processing of marketing authorisations, vari- ations and renewals by optimising internal pro- cedures and reorganising its operations. How- ever, given the backlog across all procedures, full compliance with legal deadlines for certain processes is unlikely to be achieved quickly. ALIMS has been making significant efforts to accelerate its processes, particularly the issu- ance and renewal of marketing authorisations, as well as the approval of variations and pro- motional materials for medicinal products. There are indications that simplified procedures could be introduced for medicines already approved in the EU via decentralised and mutual recognition procedures, in addition to the already available fast-track procedure for medicines approved through the EU centralised procedure. By the end of 2026, ALIMS is expected to process
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