About: EMA

EMA says not enough evidence for a second COVID booster
There is not yet enough evidence to justify additional COVID-19 boosters, according to the European Medical Authority (EMA) Head of Vaccine Strategy Marco Cavaleri, while BioNTech Pfizer have already applied for authorisation for additional jabs in the US
EU medicines agency reserves antimicrobials for humans to combat rising superbugs
The European Medicine's Agency has created a guide listing the antimicrobials which should be reserved exclusively for humans to combat antimicrobial resistance (AMR). But eyebrows were raised when one divisive antimicrobial, colistin, did not make the cut.
MEPs give green light to strengthen powers of EU’s medicines agency
European lawmakers gave their final go-ahead to the much-awaited reform of the European Medicines Agency (EMA) that will broaden its mandate.
EMA encourages COVID-19 vaccine developers to target several variants
Marco Cavaleri, the head of vaccines strategy for the European Medicines Agency (EMA), has encouraged vaccine developers to “explore the feasibility” of making multivalent vaccines: those that cross-neutralise COVID-19 virus variants.
France to adopt new ‘not so disproportionate’ health measures
France will adopt a series of health restrictions without resorting to "disproportionate measures", according to an announcement made at a press conference on Monday evening (6 December) by Prime Minister Jean Castex and Health Minister Olivier Véran.
MEP: COVID-19 was a harsh lesson but we came out with a common approach
Patient access to the same high standards of care should be at the core of the re-thinking process of health systems after the pandemic, according to Romanian Liberal MEP Nicolae Ștefănuță.
Slovenian presidency reaches agreement on expanded EMA mandate
The Slovenian presidency of the EU Council and negotiators of the European Parliament have reached a temporary agreement on an enhanced role of the European Medicines Agency (EMA) in preparedness for crises.
Opioid use: “more controlled” in Europe than in the US
The consumption of opioid painkillers increased in Europe during the COVID-19 pandemic. Is this enough to signal the risk of an opioid crisis similar to the one in the United States? Not really, experts say.
Health Brief: DG SANTE’s to-do list
Welcome to EURACTIV’s very first Health Brief! In this first edition, we spoke to the European Commission's director-general for health and food safety, Sandra Gallina, to find out what is in store this autumn when it comes to health.
Nerve disorder listed as ‘very rare’ side effect of AstraZeneca jab
The European Medicines Agency has listed the neurological disorder Guillain-Barre syndrome, which can cause temporary paralysis, as a "very rare" side effect of the AstraZeneca COVID-19 vaccine.
EU agency examines Roche arthritis drug as possible COVID-19 treatment
Europe's drugs regulator said on Monday (16 August) that it was evaluating the use of Roche's arthritis drug, Actemra, in hospitalised adults with severe COVID-19, in its latest review of a potential coronavirus treatment.
EU: too early to say if COVID booster needed as Germany, France press ahead
There's not enough data to recommend using COVID-19 vaccine boosters, the European Union's drugs regulator said on Friday, after major EU states said they would roll out a third dose for the most vulnerable from September.
Reform of EU medicines agency: Where do EU institutions stand?
The European Parliament adopted a proposal last week to broaden the mandate of the European Medicines Agency ahead of upcoming talks with member states on EMA's future role. EURACTIV takes a look at where the Parliament and the Council stand ahead of the negotiations.
Spain mulls lifting restrictions for hotels, restaurants, cafes
Spain's health ministry is in favour of gradually lifting restrictions for the hotel, restaurant and cafes sector known as HORECA and is mulling the reopening of nightlife activities for medium-risk regions for COVID-19. EURACTIV’s partner EFE reported.
Spain lifts travel restrictions for UK, Japan hoping to salvage summer
Spain has from Monday (24 May) lifted COVID-19 travel restrictions for citizens of 10 low-risk countries, including the UK and Japan, in a bid to jump-start its pandemic-stricken tourism sector in time for the summer season. EURACTIV’s partner EFE reports.
No data currently available on mixing COVID vaccines, says EMA
There are currently no guidelines on the "mixing and matching" of COVID-19 vaccines, the European Medicines Agency (EMA) clarified on Wednesday (7 April), as several European countries are now considering mixed vaccination strategies.
EU takes first step towards Russian ‘Sputnik V’ vaccine approval
The European Medicines Agency (EMA) on Thursday (4 March) began a rolling review of Russia's Sputnik V vaccine in a first step towards granting the approval of the jab across the EU.
No trace: Hungary deletes vaccine origin from jab certificate
The national Hungarian vaccination certificate will not state which type of jab was administered, according to an amendment to a government decree published on Saturday (27 February).
Commission takes action to preempt new COVID strains, fast track variant vaccines
The European Commission has launched a new bio-defence preparedness plan designed to bolster Europe’s preparedness against the looming threat of new coronavirus strains, which includes moves to fast-track future variant vaccines.
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.
Call for action over medicine shortages exacerbated by COVID-19 outbreak
Stakeholders across the EU are calling for action on medicine shortages, which they say pose severe threats to patient outcomes, patient safety and patient care. A new report released on Monday (27 April) hopes to help plug the gap.
EFSA boss: Next time we should also assess consequences without glyphosate
The next re-authorisation process for the controversial glyphosate weedkiller should also include an assessment of a potential ban of the substance in terms of food availability, biodiversity and farmers’ income, Bernhard Url told EURACTIV.com in an interview.
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.