04.07.2016

In addition to pre-registration local pharmacovigilance for the drugs in clinical research, ARS PVG experts are ready to ensure post-marketing pharmacovigilance as per Clients’ request. Since 2016, marketing authorization holder (MAH) should submit PVG reports to the Roszdravnadzor (Federal Service for Surveillance in Healthcare) once every six months during two years after drug state registration in Russia, then - annually in the next three years, and thereafter every five years. Amended FZ-61 allows biotech and pharmaceutical companies (MAHs) to delegate QPPV duties to other companies. ARS qualified team suggest its PVG support, providing savings in labor and materials costs associated with establishment of own PVG department at a biotech / pharma company in Russia.