In the Russian Federation, two codes of rules for pharmacovigilance are presently used. The local regulatory body responsible for pharmacovigilance is the Federal Service for Surveillance in Healthcare (RosZdravNadzor) and the Federal State Budgetary Institution named the Centre for Monitoring and Clinical Economic Expertise under the RosZdravNadzor.
Local requirements are covered by the Federal law 61 “On Circulation of Medicines” and Order 1071 of RosZdravNadzor “On Confirmation of Pharmacovigilance Procedures.”
Russia is also now a part of the Eurasian Economic Union (EAEU), and it will follow the norms set up by the Eurasian Economic Commission. The EAEU member states are the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, the Republic of Armenia and the Kyrgyz Republic.
On November 03, 2016, with decision no.87, the Eurasian Economic Commission ratified “Rules on Good Pharmacovigilance Practice within the Eurasian Economic Union.”
Pharmacovigilance in Russia and the EAEU operates through cooperation between all involved parties (e.g., market authorization holders (MAHs), CROs, doctors, patients, regulatory bodies). The information is also obtained from periodic safety update reports and through inspections.
A risk management plan must be prepared for each product of the MAH. Audits of the pharmacovigilance system should be planned by MAHs. A Qualified Person Responsible for Pharmacovigilance (QPPV) should be designated in the EAEU countries. The QPPV has to undergo training on the pharmacovigilance system of the respective MAH.
Good Pharmacovigilance Practice (GVP) in the EAEU utilizes pharmacovigilance principles, which are in line with the European principles, and the local Russian Order 1071 harmonizes GVP in the EAEU with local legislation.
Natalia Salamova is director of Business Development at Smooth Drug Development. Natalia has been working in the industry since 2010, with experience in international and local CROs, as well as in the Healthcare Committee of the German Bundestag. Smooth Drug Development is a full service CRO providing a full spectrum of clinical trials in Russia and CIS.
This article was reprinted from Volume 24, Issue 06, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
