Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
The State Pharmacopoeia - main standard of quality of medicines and medical devices in the Republic of Kazakhstan
Abstract
Since the publication of the first edition of the Republic’s of Kazakhstan State Pharmacopoeia (RKSP) there have been significant changes in the requirements for the pharmacopoeia, and in the understanding of its role as the main standard of quality for medicines circulating in the country. The changes affected the Pharmacopoeia’s definition, principles of and approaches to harmonization of its requirements with the leading world pharmacopoeias (European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia), as well as the structure and content of pharmacopoeial monographs. The article dwells upon such aspects as the RKSP mission, its place in the drugs standardization system and functioning mechanism, the interrelation with the requirements of the good practices (GXP), ranking of the RKSP and the leading pharmacopoeias officially recognized in the country. In connection with the publication of Volume I of the RKSP 2.0 the article discusses the status of the Pharmacopoeia and its significance in the context of recent changes.
