29 results
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Guidance for medicine developers and other stakeholders on COVID-19 (updated)
Last updated: 27/11/2020 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
Last updated: 11/11/2020 -
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Scientific advice (updated)
Last updated: 09/11/2020 -
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Requesting scientific advice or protocol assistance from EMA
Last updated: 19/10/2020 -
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Scientific advice and protocol assistance
Last updated: 19/10/2020 -
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How scientific advice works
Last updated: 19/10/2020 -
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Qualification of novel methodologies for medicine development
Last updated: 19/10/2020 -
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Parallel consultation with regulators and health technology assessment bodies
Last updated: 17/09/2020 -
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Scientific Advice Working Party
Last updated: 22/06/2020 -
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Innovation in medicines
Last updated: 18/05/2020 -
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Public health threats
Last updated: 17/12/2018 -
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Scientific advice and protocol assistance: Regulatory and procedural guidance
Last updated: 01/01/2016 -
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Non-clinical local tolerance testing of medicinal products
Last updated: 27/11/2015 -
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News: Scientific advice leads to stronger applications from industry
Last updated: 17/04/2015 -
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Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations
Last updated: 05/06/2014 -
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Modelling and Simulation Working Party
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Scientific Advice Working Party
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Scientific advice
Last updated: 31/12/2009 -
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Assessment of the genotoxic potential of antisense oligodeoxynucleotides
Last updated: 20/01/2005 -
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Need for assessment of reproduction toxicity of human insulin analogues
Last updated: 01/03/2002 -
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Development pharmaceutics
Last updated: 28/07/1998 -
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News: Responding to emerging health threats in the EU
Last updated: 17/12/2018 -
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News: EMA takes note of the European Ombudsman’s decision on pre-submission activities
Last updated: 19/07/2019 -
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News: COVID-19: developers of medicines or vaccines to benefit from free scientific advice
Last updated: 13/03/2020 -
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News: Prospective dialogue between developers and regulators makes for better evidence generation
Last updated: 27/05/2020