Research & Development
Europe's medical regulator receives application for approval of AstraZeneca/Oxford COVID-19 vaccine
12 January 2021 -

The European Medicines Agency (EMA), Europe's medicines regulator, said on 12 January 2021 that it received an application from British pharmaceutical company AstraZeneca for the conditional approval of the company's COVID-19 vaccine being developed along with the University of Oxford, Reuters news agency reported on Tuesday.

The EMA has said it would assess the application under an accelerated timeline.

In a statement, during the meeting of the European Medicines Agency's (EMA) human medicines committee (CHMP), the EMA said an opinion on the conditional marketing authorisation could be issued by 29 January 2021.

The EMA also said that during its rolling review of the vaccine, it had assessed data from ongoing trials in Britain, Brazil and South Africa.

Additional information was also provided by AstraZeneca at the request of CHMP and is currently being studied, the EMA added.