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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Coronavirus disease (COVID-19)
Keep up to date with the latest information on how EMA is handling the COVID-19 pandemic.
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Revision of Annex 1 of the EU GMP guidelines on manufacturing of sterile medicinal products
The European Commission is holding a second targeted stakeholder consultation on the updated draft Annex 1 of the EU GMP guidelines on manufacturing of sterile medicinal products. This focuses on significant modifications since the first consultation in early 2018 and aims to gather stakeholders' feedback on certain manufacturing steps.
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Brexit-related guidance for companies
Read our updated guidance to help marketing authorisation holders for both human and veterinary medicines prepare for the end of the Brexit transition period.
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From lab to patient: journey of a medicine
EMA's new interactive timeline illustrates the journey of a medicine for human use assessed by EMA. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicines. This initiative aims to improve understanding of how EMA works.
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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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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.
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