EU Drug Regulator Starts Rolling Review Of Russia's Sputnik V Vaccine - RDIF

The European Medicines Agency (EMA) has started the rolling review of the registration dossier of Russia's coronavirus vaccine Sputnik V, it will test the vaccine for compliance with EU effectiveness, safety and quality standards, the Russian Direct Investment Fund (RDIF) said on Thursday

MOSCOW (UrduPoint News / Sputnik - 04th March, 2021) The European Medicines Agency (EMA) has started the rolling review of the registration dossier of Russia's coronavirus vaccine Sputnik V, it will test the vaccine for compliance with EU effectiveness, safety and quality standards, the Russian Direct Investment Fund (RDIF) said on Thursday.

"RDIF announces the start of a rolling review procedure of Sputnik V vaccine against coronavirus by European Medicines Agency's Committee for Medicinal Products for Human Use ," the fund said in a press release.

The decision to start the rolling review is based on results of laboratory and clinical studies of he vaccine in adults, RDIF continued.

"EMA will assess Sputnik V's compliance with the usual EU standards for effectiveness, safety and quality," the press release read on.