New vivarium is an opportunity to provide home-produced medicine for Russians

To provide import substitution, Russian companies should perform their own pre-clinical and clinical studies. Such procedures are regulated by law and common all over the world. The first step of medicine’s introduction into the market is registration, – the test of quality, safety and efficiency, conducted by state authorities.   

According to Federal Laws, every registration dossier for pharmaceutical product must contain results of pre-clinical studies (with the use of lab animals).

Prof. Mikhail Pokrovskiy MD, head of BelSU Pre-Clinical and Clinical Studies Centre told that majority of unwelcomed side-effects can be eliminated during the pre-clinical studies.   

“These studies are and will be done in the vivarium strictly according to the “Rules of humane treatment of laboratory animals” and “European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes”. The special ethical committee is created for the enforcement of these rules. Despite the flashy clams about possibility of unicell organisms’, bacteria’s’ and computer models’ usage for pharmaceutical products’ research, there is no alternative other than animals. The researches, conducted on laboratory animals allow to guarantee the safety of clinical studies and people, who take new medicines”, – he said.     

So, the building of the vivarium is performed strictly according to the laws of Russian Federation which obligate scientists to conduct pre-clinical studies only with the use of vivarium. The building of vivarium is the necessity for providing Russian people with domestic pharmaceutical products made in Belgorod Region.