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EMA publishes EU strategy to 2028
The draft strategy, open for an eight-week public consultation, will…
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
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Emer Cooke
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Mitigating medicines shortages in Europe
The pharmaceutical industry must work together, applying new initiatives and…
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
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EMA prepares for winter antibiotic shortages
Anticipating similar demand of antibiotic use in prior winter seasons,…
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
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EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine…
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
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New regulation strengthens role of EMA in EU crisis response
The regulation sees tools, structures and processes set up by…
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
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EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines
Under a new initiative, the EMA will monitor on the…
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
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EMA and Health Canada to make COVID-19 vaccine data open access
Starting with the publication of clinical data used to support…
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
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European Commission approves Moderna’s COVID-19 vaccine
Moderna's COVID-19 vaccine has been approved in the EU with…
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
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EMA and HMA publish joint strategy on medicine regulation for next five years
The EMA and HMA have published their joint strategy for the…
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
