Safety, quality and efficiency of medicinal products in a global and European perspective. Some remarks
 
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Uniwersytet Warmińsko-Mazurski w Olsztynie
Publication date: 2016-12-31
 
JoMS 2016;31(4):373–394
 
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ABSTRACT
In this paper, the author characterizes the relationships between the entities that execute tasks associated with safety, efficiency and quality of medicinal products. He is interested in the correlations between the international and Europeans planes at the level of International Conference on Harmonisation of Technological Requirements for Registration of Pharmaceuticals for Human Use as well as relationships between European and national planes. The discussion of the aforementioned issues embraces comments concerning the justification of the need to intervene in the pharmaceutical market in terms of safety, quality and efficiency of such products. The investigation of relationships between global and European planes includes the characteristics of their structures, information on the implementation of the European Union guidelines, and their similarity to the guidelines of the European Medicines Agency with respect to, inter alia, recommended procedures for medicinal products assessment. The author analyzes correlations at the plane of relations between European Union member states and the European Medicines Agency with respect to medicinal products registration procedures in the European Union.
eISSN:2391-789X
ISSN:1734-2031