The Importance of digital transformation processes in medicines regulatory authorities for E-Health

Abstract

The purpose of this article is to explore the digital transformation processes in medicines and medical devices legislative. The goal of this paper is to introduce the relationship of e-business in the medicines regulation with e-pharmacy and e-health in order to improve public health. The methodology for the development of e-services, methods for modeling and analysis of business processes, the reference model of e-business in the medicines regulation, e-services for import license for medicines are the main scientific contributions of this work. This paper shows a case study which refers to e-services development for medicines in the marketing authorization, implemented in Medicines and Medical Devices of Agency of Serbia, which is a major professional contribution of this work. This research is based on a qualitative case study – the project “Digital transformation on business processes in medicines and medical devices regulation” conducted from year 2018. to 2022.