Open AccessComparative analysis of materiovigilance systems of Macedonia, USА, EU, Japan and China and their role in public health
Author(s) -
Vlatko Kokolanski,
Suzana Trajkovikj Jolevska,
Rozalinda Isjanovska,
Kiro Ivanovski,
Katarina Dirjanska
Publication year - 2019
Publication title -
arhivi na javnoto zdravje
Language(s) - English
Resource type - Journals
ISSN - 1857-7148
DOI - 10.3889/aph.2019.2843
Subject(s) - china , business , scope (computer science) , normative , public relations , public health , political science , medicine , law , computer science , nursing , programming language
Materiovigilance is a system applied for the purpose of detecting, gathering, monitoring, assessing and responding to new data on safety of medicinal products and related to the use of medical device related to possible incidents during use. The aim of this paper was to show the characteristics of the system of materiovigilance in the Republic of Macedonia compared to four other jurisdictions (US, EU, Japan and China), the recognition of the advantages and disadvantages of the systems and their impact on public health. Material and methods: For the realization of the aim of the study, we conducted an analysis of data published on the web pages of regulatory authorities related to the existing legal framework and review of the literature available on the network for scientists and researchers ResearchGate. General dialectical method as well as legal methods (dogmatic and normative method) were used in this study in order to determine the content, the meaning and the importance of the legal norms which regulate the system of materiovigilance. Results: The five systems of materiovigilance have several features that include monitoring of adverse events caused by medical device that have been granted a marketing authorization. Globally, these systems provide different, shared responsibility of all stakeholders. Thus, the scope of responsibilities of producers is significantly higher in Japan and China, opposed to the EU and Macedonia, where the responsibility is passed on to distributors, health professionals and other for-profit entities. United States is in the middle between these two extreme systems of materiovigilance, where the FDA has the responsibility to protect the public health forecasting responsibilities to the industry. Conclusion: There are significant variations in the regulation system of materiovigilance in the Republic of Macedonia and the analyzed legal systems. To date, there is no empirical evidence that one system is better than another, but it is indisputable that each system has its advantages and disadvantages regarding the protection of public health. Within the analyzed systems of materiovigilance three best practices can be seen that contribute to the improvement of public health: transparency, repeating the examination of medical device and central versus local control.