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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Applying for a medicine to be used both in and outside the EU
EMA is inviting comments on its draft guidance on applying in parallel for an EU marketing authorisation and an opinion under its ‘EU-M4all’ procedure for a medicine to be used outside the EU. The deadline to comment is 15 February 2021.
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EMA celebrates 15 years supporting SMEs in the EU
EMA’s recent roundtable with SME stakeholders and latest SME survey results highlight the key achievements of the SME Regulation and the challenges and opportunities for EU support to SMEs in the pharmaceutical sector.
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Paediatric medicines: progress on action plan
A progress update is available on the EMA / European Commission action plan for supporting the development of medicines for children. It specifies the status of each action and outlines concrete achievements to December 2020.
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European medicines agencies network strategy to 2025
The strategy sets out how the network will continue to enable the supply of safe and effective medicines, in the face of developments in science, medicine, digital technologies, globalisation and emerging health threats, such as the COVID-19 pandemic.
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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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New online platform for scientific advice
From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice. Guidance is available on how to register for IRIS and use it for scientific advice and other procedures..
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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