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Study shows alignment in authorisation of new medicines between EU and US
Study shows alignment in authorisation of new medicines between EU and US
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Study shows alignment in authorisation of new medicines between EU and US
Study shows alignment in authorisation of new medicines between EU and US
EMA and FDA are aligned in more than 90% of marketing authorisation decisions for new medicines according to analysis that looked at data from 2014 to 2016.
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From lab to patient: the journey of a centrally authorised medicine
From lab to patient: the journey of a centrally authorised medicine
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From lab to patient: the journey of a centrally authorised medicine
From lab to patient: the journey of a centrally authorised medicine
EMA has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to medicines across the EU.
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Supporting medicine developers in generating quality data packages in early access approaches
Supporting medicine developers in generating quality data packages in early access approaches
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Supporting medicine developers in generating quality data packages in early access approaches
Supporting medicine developers in generating quality data packages in early access approaches
EMA has published a report on its 2018 workshop that explored how to better support medicine developers generate quality data packages in early access approaches in the EU and the US. The workshop was organised with the US FDA.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information on exemptions for batch testing to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
