Quality Assurance of Medicines: The State and Trends of the European Union and Ukraine Legislation Development

Abstract

The aim: Scientific substantiation of the state and tendencies of development at the present stage of the legislation of the European Union and Ukrainian legislation on quality assurance of medicines. Materials and methods: Using the biblio-semantic, systematic-review, analytical, formal-legal and comparative-law methods, the individual regulatory sources of pharmaceutical legislation of the EU and Ukraine were studied. Conclusions: The paper identifies that pharmaceutical legislation of the EU and Ukraine on quality assurance of medicines at the present stage of their development have common features, which include the number, disorder of existing legal acts, which creates conflicts between them and the potential for gaps in regulation. The main trend in the development of this legislation in the EU and Ukraine is the disparity of legal acts and the lack of significant legislative efforts to codify them.