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EMA European Medicines Agency
EMA European Medicines Agency
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Trending Articles
How advanced technologies are unlocking the future of drug manufacturing
As the drug production landscape changes, it opens the door to pursue hybrid opportunities that push the boundaries of technological advancement in the field, reports Jon...
Actylis and Novo Nordisk Pharmatech partner for the distribution of benzalkonium chloride
The two companies aim to expand the distribution of benzalkonium chloride within Europe
Upperton opens novel development and GMP manufacturing facility
The novel 50,000 sqft development and GMP manufacturing facility in Nottingham contains ten GMP manufacturing suites, quality control laboratories and formulation development...
Astellas begins construction of manufacturing site in Tralee
600 construction jobs and 100 specialised engineering, science and technology roles will be created from the project
Policy vacuum risks UK becoming a medicines supply backwater
The UK becoming a "backwater" supply marker could jeopardise £18bn of NHS savings from newly off-patented drugs during the next five years
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9-12 April 2024 | Exhibition | RAI Amsterdam
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EMA issues positive opinion on Calliditas' orphan drug
Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
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Moderna receives positive opinion from the EMA for Spikevax
Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation
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EMA celebrates 25 years of regulatory management
The EMA was founded in January 1995
Regulatory
EMA publishes draft guideline on quality requirements for DDCs
The latest document focuses on combinations of medicinal products and medical devices
Regulatory
GMP inspection in Bulgaria and Cyprus now on par with US
A mutual recognition agreement between the EU and the US regulatory bodies aims to encompass all EU member states, now standing at 24 of the 28
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Brexit update: UK Inspection Reports and GMP Certificates
The ECA Academy sheds light on the latest Brexit guidance documents released by the European Medicines Agency
Regulatory
Poland and Slovenia join EU-US mutual recognition agreement for inspections
GMP drug plant inspections conducted by health authorities in Poland and Slovenia will now be accepted by the US FDA
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