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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SME survey 2020
EMA invites small and medium-sized enterprises (SMEs) and interested stakeholder organisations to complete a short survey by 10 March 2020 to help EMA understand their current challenges and tailor its future activities to their needs.
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Upgrade of EU register of post-authorisation studies (EU PAS Register)
In January 2020, EMA has introduced new functionalities to the EU PAS Register to meet stakeholder needs and further increase transparency on post-authorisation studies. These include an option to delay protocol publication until the end of the study, provision of information on the date of first registration of a study in the EU and enhanced search features.
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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.
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Preventing Brexit-related medicine shortages
EMA has published a questions-and-answers document to address potential questions from stakeholders on the supply of medicines in the EU after Brexit and what the Agency, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit.
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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