BDK Advokati’s partner Bisera Andrijašević and Associate Anja Gligorević authored the chapter on Serbia featured among 21 jurisdictions in the 2024 edition of the Chambers’ Life Sciences Global Practice Guide. The chapter provides a snapshot of the life sciences regulatory landscape in Serbia in the current dynamic global regulatory climate. Global pharmaceutical industry is facing numerous challenges related to increased regulation, antitrust scrutiny, and influence of AI and digital transformation. The EU pharmaceutical legislation is undergoing the biggest transformation in more than 20 years, and the proposed extensive changes could eventually have a profound effect as well on industry players doing business in Serbia as an EU candidate country. Meanwhile, Serbia is investing efforts to make itself attractive as a biotech and pharmaceutical innovation hub not only in Europe, but worldwide.
The Serbian chapter gives an overview of the topics such as the challenging the decisions of regulatory bodies, conduct of clinical trials and related data protection issues, the marketing, manufacturing and distribution of pharmaceuticals and medical devices, pricing of medicines, digital healthcare, and patents. We will keep the online chapter updated in line with any notable changes of the regulatory regime.
To access the entire guide online, use the following link: Life Sciences 2024
