Pharmacovigilance requirements in Russia and Kazakhstan

A common Eurasian pharmaceutical market was supposed to go into effect on 1 January, 2016. The market came into effect in May 2017 – over one year later. Although there were many reasons for the delay, the unification of the national legislations of member states has been mentioned as a primary cause. Pharmacovigilance responsibilities carry significant impact and are concerned with the necessity of immediate action in the case of legislation changes. The basic principles of the common pharmacovigilance approach have been available for use for more than one year; however, the official approval by the Eurasian Economic Commission was granted in November 2016. Despite the emerging market, the national approach will remain, and comparison of local/centralized legislation is required. This article is a comprehensive analysis of pharmacovigilance requirements in the largest markets of the Eurasian Economic Union: Russia and Kazakhstan. Basic knowledge regarding common requirements is provided.