The European Commission has published the first Union list of critical medicines, together with the European Medicines Agency (EMA) and the Member States’ Heads of Medicines Agencies (HMA). The publication follows the commitment made in the Commission’s Communication on addressing medicine shortages in the EU to accelerate the work on this list, originally announced in the EU’s pharmaceutical […]
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COVID-19: European Commission authorises third vaccine for Member States’ autumn vaccination campaigns
The Commission has authorised the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, developed by Novavax. This is another important step in the fight against the disease. It is the first protein-based adapted vaccine authorised for this autumn and winter season. The European Medicines Agency (EMA) carried out an in-depth evaluation of the vaccine. Following this evaluation, the Commission […]
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European Commission steps up action to tackle critical shortages of medicines and strengthen security of supply in the EU
The Commission has adopted a set of actions to better prevent and mitigate critical medicine shortages in the EU, this winter, next winter and beyond. Recent critical shortages, including of certain antibiotics last winter, show that continued coordinated action is needed to address supply challenges and to make Europe’s medicine supply chains more resilient in […]
Read MoreCommission authorises second adapted vaccine for Member States’ autumn vaccination campaigns
The Commission has authorised the Spikevax XBB.1.5-adapted COVID-19 vaccine, developed by Moderna. This is another important step in the fight against the disease. It is the third adaptation of this vaccine to respond to new COVID-19 variants. The European Medicines Agency (EMA) carried out a stringent evaluation of the vaccine under the accelerated assessment mechanism. Following this […]
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Parliament endorsed new measures to better protect citizens who donate blood, tissues or cells
MEPs adopted the report on new rules governing the use of so-called substances of human origin (SoHO) in the EU, with 483 votes in favour, 52 against and 89 abstentions. The measures apply to substances – such as blood and its components (red/white cells, plasma), tissues and cells – used for transfusions, therapies, transplantations or […]
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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 actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These recommendations, which have been developed through the Executive Steering Group on Shortages and Safety […]
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EU steps up the fight against antimicrobial resistance
The Commission welcomes the adoption by the Council of the European Union of the Commission’s proposal to strengthen EU action against antimicrobial resistance (AMR). Announced together with the Commission’s revision of the pharmaceutical legislation on 26 April, the AMR Recommendation helps combat AMR in the fields of human, animal and environmental health, following the so-called One Health approach. […]
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European Parliament calls for prudent use of antibiotics and more support for research
Parliament adopted its recommendations on Thursday for a coordinated EU response to health threats posed by antimicrobial resistance. In a resolution passed with 525 votes in favour, two against and 33 abstentions, MEPs say the successful tackling of antimicrobial resistance (AMR) requires the prudent use of antibiotics for humans and animals, good infection prevention and […]
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Commission secures agreement with BioNTech-Pfizer on the delivery of COVID-19 vaccines
The European Commission, acting with and on behalf of EU Member States through the Health Emergency Preparedness and Response Authority (HERA), and vaccine developers BioNTech-Pfizer, have reached an agreement to better address Member States’ assessment of evolving needs for COVID-19 vaccines. The amendment to the existing vaccines supply contract takes into account the improved epidemiological […]
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