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EU-US mutual recognition agreement extendedMutual recognition agreement |veterinary medicines
EU-US mutual recognition agreement extended
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EU-US mutual recognition agreement extendedMutual recognition agreement |veterinary medicines
EU-US mutual recognition agreement extended
The agreement allows EU and US authorities to recognise each other’s inspections of manufacturing facilities of some veterinary medicines
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Adapting COVID-19 vaccines to future variantsCOVID-19 |International collaboration
Adapting COVID-19 vaccines to future variants
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Adapting COVID-19 vaccines to future variantsCOVID-19 |International collaboration
Adapting COVID-19 vaccines to future variants
Global regulators agreed on a way forward to adapt COVID-19 vaccines to future variants, during a workshop co-chaired by EMA and the FDA, under the umbrella of ICMRA
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CHMP highlights: May 2023MEDICINES |COMMITTEES
CHMP highlights: May 2023
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CHMP highlights: May 2023MEDICINES |COMMITTEES
CHMP highlights: May 2023
EMA's human medicines committee (CHMP) recommended 2 new medicines for approval in the EU at its May 2023 meeting
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2022 annual report publishedEMA |About us
2022 annual report published
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2022 annual report publishedEMA |About us
2022 annual report published
EMA has published its 2022 annual report that provides an overview of the Agency’s major achievements, key figures and contributions to public and animal health in Europe
Latest news
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List item31/05/2023
Progress with EU-US mutual recognition agreement for inspections for veterinary medicines
Today, the European Union (EU) and the United States (US) have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug Administration (FDA) has...
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List item30/05/2023 COVID-19
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition based on the emerging evidence on coronavirus SARS-CoV-2 variants...
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List item26/05/2023
EMA business hours over Whit Monday, 29 May
The European Medicines Agency's (EMA) office is closed on Monday 29 May 2023. Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600. Please note that this is an emergency number...
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List item26/05/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 May 2023
Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. The committee recommended granting a marketing authorisation for Pylclari (piflufolastat (18F)),...
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List item22/05/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023
CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6 The Committee adopted by consensus a positive opinion for a marketing authorisation application for Eluracat ( capromorelin tartrate ), from Elanco GmbH, a new product for...
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List item17/05/2023
Guidance for industry to prevent and mitigate medicine shortages
EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine shortages are a global health problem and are increasingly affecting...
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