ABSTRACT

The market share of the pharmaceutical industry in Common Wealth of Independent States (CIS) countries has grown exponentially in recent years. To be sold in CIS nations, the pharmaceuticals must be licensed by regulatory authorities. Every country in the CIS region has its regulations, which have to be followed by the pharmaceutical manufacturer to get approval from the regulatory authority. For the submission to the regulatory authority, the dossier must be prepared which consists of both technical and administrative information. The dossier may be in any of the formats of CTD / country-specific CTD format. The dossier must be submitted in the local language, which made it difficult to apply to the CIS countries. This study aims to look at the regulatory requirements for marketing authorization in Russia, Kazakhstan, and Uzbekistan. Keywords: CIS countries, marketing authorization, regulatory authorities, CTD
Publication date: 01/09/2022

https://ijbpas.com/pdf/2022/September/MS_IJBPAS_2022_6350.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.9.6350