[Demonstration of quality, safety and efficacy of biological products subject to changes in their manufacturing process].

Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the product to demonstrate that modifications did not occur that would adversely impact the safety and efficacy of the drug. Where there is the lack of a sound legal basis, there is a need in harmonization of current Russian legislation with international and European rules governing medicinal product for human use to ensure quality, safety and efficacy thereof.