EU authorizes third adapted COVID-19 vaccine for Autumn campaigns
The European Medicines Agency (EMA) carried out an in-depth evaluation of the vaccine. Following this evaluation, the Commission authorised the…
EMA: EU Council and Parliament strike deal on a sustainable and flexible fee system
The presidency of the Council and European Parliament negotiators reached a provisional agreement on a regulation to modernise and simplify…
Joint EMA-ECDC press briefing on current state of respiratory diseases and treatments
As autumn season approaches, the European Medicines Agency (EMA) and the European Centre for Disease...
COVID-19: EU Commission authorises second adapted vaccine for Member States
The European Medicines Agency (EMA) carried out a stringent evaluation of the vaccine under the accelerated assessment mechanism. Following this evaluation, the…
EMA reflects on the use of artificial intelligence in the lifecycle of medicines
The reflection paper is part of the joint HMA-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines…
Health: EU steps up action to prevent shortages of antibiotics for next winter
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are today issuing recommendations for…
Main results: Employment, Social Policy, Health and Consumer Affairs Council, 12-13 June 2023
The presidency and the Commission informed delegations about the negotiations for an international agreement on pandemic prevention, preparedness and response as well…
EMA: EU Council agrees approach on a more modern and simplified fee structure
The proposed regulation aims to update the existing legislation governing fees charged by EMA. It will ensure that fees and remuneration…
EMA and ECDC update on COVID-19 vaccines to target new SARS-CoV-2 variants
News 06/06/2023 The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency...
EMA: Interrogation network completes 1st studies, calls for new data partners
News 28/03/2023 DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year...
Vaccine monitoring: ECDC and EMA collaborate on vaccine safety and effectiveness
Stockholm/Amsterdam, 8 December 2022 The European Medicines Agency (EMA) and the European Centre for Disease...
EU/HMA Big Data Stakeholder Forum 2022
Table of contents Event summary Live broadcast – 09:00-17:55 Amsterdam time (CET) Documents Related content...
European Health Union: Building a stronger EU health response
Brussels, 24 October 2022 Today, the Council has adopted the final building blocks of the European...
COVID-19: EP mission assesses work of EMA and BioNTech
Brussels, 21 September 2022 On 20-21 September, a delegation of the special committee on COVID-19...
ECDC and EMA recommendations on use of adapted COVID-19 vaccines
Solna, 6 September 2022 The European Centre for Disease Prevention and Control (ECDC) and the...
COVID-19: Stella Kyriakides on the first variant-adapted booster vaccines
Brussels, 1 September 2022 Today, the European Medicines Agency (EMA) has given a positive opinion...
EU Commissioner Kyriakides on the intradermal use of monkeypox vaccine
Brussels, 19 August 2022 Today, the European Medicines Agency (EMA) has advised on intradermal use of monkeypox...
COVID-19 vaccines: ECDC and EMA update recommendations on booster doses
11 Jul 2022 The European Centre for Disease Prevention and Control (ECDC) and the European...
EU Member States support designated antimicrobials reserved for humans
Brussels, 4 Jul 2022 Today, Member States have given their support to the establishment of...
mRNA COVID-19 vaccines: ECDC and EMA issue advice on 4th doses
6 April 2022 The European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19...
EU Digital COVID Certificate: 270-day acceptance period starts tomorrow
31 January 2022 As of tomorrow, 1 February, the new rules start applying on a...
Clinical trials: New EU rules to improve safety and transparency
Brussels, 28 January 2022 As of Monday 31 January, the assessment and supervision of clinical trials throughout...
European Medicines Agency: Strengthening the European Health Union
Brussels, 25 January 2022 Today, as part of the on-going work to build a strong...
BEUC on new EMA role: Campaign to limit medicine shortages gets boost
20.01.2022 Europeans are likely to be better protected from medicine shortages during health crises after...
European Medicines Agency: EU Parliament endorses stronger role
Better crisis preparedness and management for medicinal products and medical devices New EU platform to...
EMA: Global regulators discuss regulatory alignment on Omicron variant response
13/01/2022 On 12 January, regulators from around the world discussed the global regulatory response to...
EMA: Accelerating Clinical Trials in the EU (ACT EU) to address patients’ needs
13/01/2022 Today, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency...
EMA recommends approval for use of RoActemra in adults with severe COVID-19
Amsterdam, 6/12/2021 The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the indication of RoActemra...
ICMRA and WHO map out regulatories’ flexibilities to respond to COVID-19
03/12/2021 The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of...
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
News 02/12/2021 EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a...
EMA: Executive Director to update MEPs on COVID-19 vaccines and treatments
MEPs will quiz EMA Executive Director Emer Cooke on the latest developments regarding COVID-19 vaccines...
EU Parliament: Deal on stronger role for EU medicines regulator
EU better equipped to manage future health crises after COVID-19 lessons learned More effective in...
Provisional agreement between Council and EU Parliament to reinforce European Medicines Agency
Today, the EU Council presidency and European Parliament negotiators reached a provisional agreement on a...
European Medicines Agency: EU Commission welcomes agreement
Brussels, 28 October 2021 Today, the European Parliament and the Council reached a political agreement...
Purchase of the Russian vaccine ‘Sputnik V’ by the regional government of Madrid without prior centralised authorisation from the EMA – EU Commission answer
Answer given by Ms Kyriakides on behalf of the European Commission (27.8.2021) 1. By concluding...
EU Commission approves new contract for a potential COVID-19 vaccine with Novavax
Today, the European Commission has approved its seventh Advanced Purchase Agreement (APA) with a pharmaceutical...
ECDC: Full vaccination key to protecting against serious COVID-19
With the increasing circulation of the Delta variant of SARS-CoV-2 in EU/EEA countries, the European Medicines Agency...
Use of antibiotics in animals is decreasing – joint JIACRA report ECDC, EFSA, and EMA
The use of antibiotics has decreased and is now lower in food-producing animals than in...
S&Ds: A stronger European Medicine Agency brings the creation of a Health Union closer
A stronger European Medicine Agency (EMA) with a reinforced transparency, participation, coordination and prevention –...
EU Council agreement paves way to reinforce European Medicines Agency
The Council has reached an agreement on draft rules to reinforce the role of the...
EMA: EU Council agreement paves way to reinforce European Medicines Agency
15 June 2021, 12:45 The Council has reached an agreement on draft rules to reinforce...
EU Commission Answer to a written question – Transparency regarding the functioning of the EMA
See question(s) : E-001513/2021 Source : © European Union, 2021 – EP Source: Answer to...
EU Therapeutics Strategy: EMA starts first rolling review of a new COVID-19 medicine
The European Medicines Agency has today started the rolling review of sotrovimab (VIR-7831), a monoclonal antibody developed...
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
News 20/04/2021 EMA confirms overall benefit-risk remains positive At its meeting of 20 April 2021,...
EU Commission changes procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants
Today, as an immediate action under the HERA Incubator, the new European bio-defence preparedness plan...
MEPs quiz EMA Executive Director Emer Cooke on the evaluation and authorisation of COVID-19 vaccines
MEPs will quiz EMA Executive Director Emer Cooke on the latest developments regarding the evaluation...
COVID-19 variants: MEPs share concerns about efficacy of vaccines
On Monday, Members of the Environment, Public Health and Food Safety Committee debated with experts...
COVID-19 vaccines: MEPs to debate concerns about virus mutation
MEPs will address their questions to experts on COVID-19 variants and the vaccines’ efficacy against...
DRAFT OPINION on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices – PE689.565v01-00
DRAFT OPINION on the proposal for a regulation of the European Parliament and of the...