About: European Medicines Agency

Global Europe 19-02-2021

Slovak party derails plan to buy Russian vaccine without EU registration

Slovakia has dumped a plan to negotiate with Russia to buy the Sputnik V vaccine, after a junior coalition partner vetoed buying a product which has not been registered by the European Medicines Agency, Prime Minister Igor Matovič said.
Health 07-01-2021

EU to approve extraction of sixth dose from Pfizer-BioNTech vaccine vials

The European drugs regulator could soon give the go ahead for an extra sixth dose to be extracted from Pfizer-BioNTech COVID-19 vaccine vials, lifting the number of available shots at a time when supplies are short.
Health 06-01-2021

EU watchdog gives green light for second Covid jab

The EU's medicines watchdog approved on Wednesday (6 January) a coronavirus jab by US firm Moderna, giving a shot in the arm for Europe's slow-moving vaccine roll-out.
Health 06-01-2021

EU could authorise a second vaccine ‘in coming hours’

The European Union could authorise a second coronavirus vaccine "in the coming hours", European Council chief Charles Michel said Tuesday (5 January), adding that leaders would hold a virtual summit on the health crisis later this month.
Health 05-01-2021

No EU decision on Moderna shot as blame game mounts

The EU's drugs watchdog held off authorising Moderna's coronavirus jab on Monday (4 January), as criticism mounts of the bloc's slow vaccine roll-out.
Health 21-12-2020

Five key things about EMA’s vaccine decision

The European Medicines Agency (EMA) will decide on Monday (21 December) whether to give the green light for the Pfizer-BioNTech coronavirus vaccine within the EU.
Health 15-12-2020

Pressure mounts on EU drug regulator to speed-up approval of COVID-19 vaccine

Europe's drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by US giant Pfizer and Germany's BioNTech, officials said, as inoculations get started in Britain and the United States.
Cybersecurity 10-12-2020

Vaccine documents hacked at EU medicines agency

Two pharmaceutical companies in line for first conditional approval for their Covid-19 vaccine by the EU's medicine regulator said Wednesday (9 December) their documents were "unlawfully accessed" during a cyberattack on a European Medicines Agency server.
Coronavirus 10-12-2020

EMA director: Europeans are better protected with ‘EU licensed’ COVID vaccine

In an exclusive interview in Amsterdam with EURACTIV’s partner EFE, Emer Cooke, the executive director of the European Medicines Agency (EMA), stressed that Europeans are much “better protected" if the COVID-19 vaccine is authorised by the EU agency.
Brexit 03-12-2020

EU criticises, US cheers UK approval of Pfizer-BioNTech COVID-19 vaccine

The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday (2 December), saying its own procedure was more thorough, while US health experts welcomed the British move as a sign US regulators should follow suit.
Coronavirus 16-11-2020

Conditional authorisation ‘most likely’ for COVID-19 vaccine, EMA says

The most likely scenario for COVID-19 vaccine candidates in the EU is a one-year conditional marketing authorisation (CMA), European Medicines Agency (EMA) sources have told EURACTIV.
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Health 26-10-2020

Progress but the fight against COVID-19 is just beginning

Over the last few weeks, the European Medicines Agency (EMA) announced they have begun a “rolling review” process on COVID-19 vaccines from AstraZeneca in collaboration with Oxford University, Moderna and from Pfizer in partnership with BioNTech. The announcements are indicative...
Health 19-05-2020

Vaccine hesitancy creates concern in the fight against COVID-19

Scepticism about adverse effects and actual lack of efficacy in immunisation practices can become an important negative factor when a vaccine against coronavirus becomes available, according to the head of the EU's medicines agency (EMA), Guido Rasi.
Health 06-02-2020

Europe dodges US fentanyl crisis but for how long?

When 18-year-old Joseph bought a pill at a fun fair in the French Riviera resort of Cannes, he was convinced it was morphine.
Health 25-11-2019

MEP: EU framework on medical cannabis to give ‘peace of mind’ to patients

A strong EU regulatory framework on medical cannabis is needed to provide investors with stability but also to give peace of mind to patients struggling with fragmented legislation among member states, socialist MEP Miriam Dalli said.
Health 12-11-2019

Europe gives go ahead to market Ebola vaccine

The European Union authorised the marketing of a vaccine against Ebola on Monday (11 November), permitting the first wider commercial use of a protection that has helped stem an outbreak in DR Congo.
Brexit 21-02-2019

Brexit turns EU into landlord in the City of London

The European Medicines Agency is looking to sublet its former headquarters in the financial district of London, after a British court ruled on Wednesday (20 February) that it cannot break its lease despite the UK’s withdrawal from the EU.
Brexit 10-01-2019

Clogs gift for EU medicines agency’s Brexit move

Dutch officials handed over a pair of clogs and the keys to the European Medicines Agency's temporary base in Amsterdam on Wednesday (9 January) as the watchdog prepares to leave London after Brexit.

European Medicines Agency launches review of recalled heart drug

The European Medicines Agency (EMA) said Thursday it is conducting a review of the health effects on patients of a widely used blood pressure medication recalled around the world last month.
Health 02-08-2018

EU drugs agency to see 30% staff losses over Brexit move

The European Medicines Agency (EMA) is to scale back operations further as it copes with higher than expected staff losses, triggered by the watchdog's forced relocation from London to Amsterdam because of Brexit.
Health 22-02-2018

Health care risks being forgotten in Brexit talks, industry warns

Health risks being forgotten in Brexit negotiations, potentially delaying the availability of new medicines and imposing large costs on manufacturers, public health leaders have warned.
Brexit 07-02-2018

Italian pharma chief: Dutch EMA bid ‘may have misled’ the Commission

The smooth transition of the EU drug agency from London to Amsterdam is threatened by delays in the Netherlands, whose bid to win the agency may have been misleading, a top representative of Italian pharmaceuticals told EURACTIV.com.
Health 31-01-2018

Dutch official: The EU drug agency transition has been ‘by the book’

The preparations for relocating the European Medicines Agency to the Netherlands next year are underway and on schedule, a senior Dutch government official in the EU told EURACTIV.com on Wednesday (31 January), after recent media reports suggested that Italy wants to appeal to the EU Court.
Brexit 30-01-2018

Italy cries foul over temporary accommodation of EU Medicines Agency

Dutch officials and the head of the European Medicines Agency (EMA) sought yesterday (29 January) to allay any jitters among the agency's 900 London-based staff who are being asked to move to Amsterdam because of Britain's departure from the EU.
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