THE HAGUE, April 7. /TASS/. The European Medicines Agency (EMA) is going to inspect the good clinical practice in respect of the Russian coronavirus vaccine Sputnik V, EMA Executive Director Emer Cooke said at a press conference on Wednesday.
"We have announced that we started a rolling review of the Sputnik V vaccine and this means that we are currently looking at the available evidence to see whether it meets standards it will need [to meet] for evaluation in the EU," the official said. "We would be performing good clinical practice inspection in Russia and this is evaluation of the way the trials were conducted," she noted.
"This is a normal procedure that we follow for many vaccines and medicines," Cooke said.
Inspection of the good clinical practice is a standard process for all vaccines within the framework of approval by EMA, Sputnik V vaccine developers tweeted on Wednesday. Fifty nine countries have already confirmed that the Sputnik V conforms to the good clinical practice and we expect EMA will do the same, the vaccine developers noted in Twitter.