Registration procedure of generic drugs in the Republic of Kazakhstan and Europe: Review

Abstract

Before the medicines enter the pharmaceutical market of the Republic of Kazakhstan, the applicant must pass the registration procedure. The process of registration of medicines is necessary to provide the population of Kazakhstan with high-quality, effective and safe medicines, which, in turn, will lead to an improvement in the general health of the population. The study of the registration process of generic medicines is an urgent problem for practical healthcare, which causes scientific and practical interest in this issue and serves as the basis for this study. The search for health policy literature was carried out on the official websites: www.who.int, www.ndda.kz, www.ema.europa.eu and the search for scientific publications was carried out in the search engines: PubMed, GoogleAcademia, eLibrary.ru, Cyberleninka. Further scientific developments in this direction will be of particular relevance and will allow not only to give a comparative description of the registration process of generic medicines, but also to develop recommendations for its improvement.

Keywords

• drug
• generic
• medicines
• regulatory requirements
• registration process
• Republic of Kazakhstan