The modern state and development trends of the normative legal adjusting in the sector of the quality assurance of medicinal products

Анотація

The one of important factors of creation and effective functioning of the quality assurance system of medicinal products is the normative adjusting of the questions related to her through normative legal acts, harmonized with corresponding international and European documents. Aim of work – the analysis of the modern state and development trends of normative legal and normative technical base of Ukraine in the sector of quality assurance of medicinal products. Subjects: scientific publications, analytical materials, public information, normative legal acts, normative documents. Methods: system overview, bibliographic, historical, logical, graphic modeling. The subjects of legislative and normative activity in the sector of quality assurance of medicinal products are certain. The operating legislative acts and normative documents, regulative different aspects of quality assurance of medicinal products, are analysed. It is shown that the modern process of development of national pharmaceutical sector is characterized by active introduction of international standards of the Good Practices. It will allow to create the system of quality assurance of medicinal products on all stages of their life cycle. The complex of the Good Practices of medicinal products, accepted and pre-arranged to the acceptance in Ukraine is analysed. The prospects of development of normative legal and normative technical base in the sector of quality assurance of medicinal products in the conditions of reformation of pharmaceutical sector of health protection of Ukraine and his adaptation to the requirements of European Union are certain.

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