Pharmaceutical industry
On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events. You can contribute to the Agency’s work by responding to public consultations. Learn more about how the pharmaceutical industry is actively involved in the work of the Agency.
Featured information
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Responsible use of antibiotics: What’s your role?
To mark European Antibiotic Awareness Day on 18 November 2019, EMA has launched a social media campaign to highlight the importance of using antibiotics responsibly. The campaign includes visuals describing what ‘responsible use’ means for medicine developers.
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Update on nitrosamine impurities
EMA has updated the questions-and-answers document for marketing authorisation holders who are currently reviewing their medicines for the possible presence of nitrosamines and testing products at risk. The updated document lists potential sources of nitrosamine contamination that have been identified to date. This information can support companies in their ongoing review of their manufacturing processes.
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Brexit preparations
In July 2019, EMA and the European Commission provided additional information on exemptions for batch testing to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
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Early access approaches in the EU and the US
EMA has published a report on its joint stakeholder workshop with the US Food and Drug Administration (FDA) that explored how to better support medicine developers generate quality data packages in early access appraches in the EU and the US, including the PRIME scheme in the EU and the Breakthrough Therapy designation in the US.
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Supporting medicine developers
EMA's infosheet highlights the regulatory tools EMA offers to support the development of new and innovative medicines – from the early phases in the laboratory all the way to the patient.
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The journey of a centrally authorised medicine
EMA's booklet describes the journey of a medicine for human use authorised via EMA, from initial research to discussions on patient access to medicines across the EU. This includes how EMA supports medicine development by providing scientific advice and how it assesses a medicine’s benefits and risks once it receives an application for marketing authorisation.
Key content
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Research and development
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Innovation in medicines
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Pharmacovigilance
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Data on medicines (ISO IDMP standards)
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United Kingdom’s withdrawal from the European Union ('Brexit')
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Supporting SMEs
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PRIME: priority medicines
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Antimicrobial resistance