About: EMA
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.
Does fast-track drugs approval in EU run too fast?
More than two years after its launch, the EU's fast-track approval process for marketing new drugs, called PRIME, is broadly welcomed by patients and industry, walking the fine line between patients' safety and expediency, and between the need to foster innovation and remaining abuse-proof.
NHS faces ‘serious challenges’ from Brexit, warns new report
Brexit poses “serious challenges” to the NHS in the form of longer waiting times, staff shortages and delays in the approval of new medicines, according to a report published on Wednesday (14 March).
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.
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.
Stakeholders call for more transparent meetings between pharma and EMA
Public health organisations and EU lawmakers say the closed-door meetings before the submission of a new drug between the pharma industry and the European Medicines Agency (EMA), a key player in the continent’s healthcare industry, should be more transparent.
Access to clinical trials and innovative treatments at risk after Brexit
LONDON: Patients in Britain risk delays to access life-saving medicines if the UK deviates from EU regulatory standards post-Brexit, a leading medical representative has warned.
Paris celebrates the arrival of the European Banking Authority
At the end of a suspenseful day, delegates from 27 EU governments meeting in the General Affairs Council chose to relocate the European Medicines Agency to Amsterdam and the European Banking Authority to Paris. EURACTIV France reports.