Sputnik V not under regulatory review in Europe

11 February 2021

The European Medicines Agency (EMA) has issued a statement clarifying that it has not received an application for a rolling review or a marketing authorization for Russia’s homegrown vaccine, Sputnik V.

Earlier in the week, media outlets including The Moscow Times reported that European authorities had approved an application.

The Moscow Times claimed it was “now up to the EMA to grant conditional marketing authorization to the vaccine so it can be centrally supplied.”

On the contrary, the EMA stated that it had provided scientific advice regarding the latest regulatory guidance for the development of the vaccine.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK