EMA Chief Reaffirms Agency's Plans For On-SIte Visits In Russia For Sputnik V Vaccine
The executive director of the European Medicines Agency (EMA), Emer Cooke, confirmed Wednesday that the regulator's experts were planning on-site visits in Russia as part of its review of Sputnik V coronavirus vaccine
MOSCOW (UrduPoint News / Sputnik - 07th April, 2021) The executive director of the European Medicines Agency (EMA), Emer Cooke, confirmed Wednesday that the regulator's experts were planning on-site visits in Russia as part of its review of Sputnik V coronavirus vaccine.
Earlier in the day, the Financial Times reported that the regulator was about to to launch a probe into compliance with ethical and scientific standards at clinical trials of Sputnik V.
"We have announced that we started a rolling review of the Sputnik V vaccine. This means that we're currently looking at the available evidence to see whether it meets the standards we would need for evaluation in the EU," Cooke said.
"We will be performing good clinical practice inspection in Russia and this is an evaluation of the way the trials were conducted that allowed the results to be generated, and this is a normal procedure that we follow for many vaccines and medicines depending on our knowledge of the trials that have been conducted," Cooke added.
Marco Cavaleri, a senior official at the EMA, announced earlier in March that the agency would send a team of experts to Russia in April to review clinical trials and the production of the Sputnik V coronavirus vaccine.