The European Medicines Agency will start next week to review the compliance of the conduct of clinical trials of the Russian vaccine against COVID-19 Sputnik V with ethical and scientific international standards
The EMA will examine whether the trials of the Russian drug do not contravene “good clinical practice” standards, in particular whether the rules of GCP, an international clinical standard, have been followed.
“Compliance with this standard provides assurance that the rights, safety and welfare of trial participants are protected and that clinical trial data are reliable”, – the EMA said in a statement.
It said that the regulator can order a special review if problems are identified.