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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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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The journey of a centrally authorised medicine
EMA's new 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.
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Use the IRIS system for orphan designation activities
From 19 September 2018, sponsors need to use EMA's secure online IRIS system to submit applications for orphan designation and to manage pre- and post-designation activities.
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Brexit preparations
In February 2019, EMA and the European Commission updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
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EU innovation network
EMA's video on the EU innovation network explains how EMA and this dedicated network can support micro, small and medium-sized enterprises (SMEs) and academics in implementing their innovative ideas in medicine development.
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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