25 results
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PRIME: priority medicines (updated)
Last updated: 01/03/2023 -
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Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need - Scientific guideline
Last updated: 22/04/2021 -
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Accelerated assessment
Last updated: 17/02/2021 -
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Conditional marketing authorisation
Last updated: 21/12/2020 -
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Compassionate use
Last updated: 26/10/2020 -
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Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies
European Medicines Agency, London, UK, 26/11/2018, Last updated: 31/07/2019 -
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Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025
European Medicines Agency, London, UK, 24/10/2018, Last updated: 08/11/2018 -
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News: Two years of PRIME
Last updated: 07/05/2018 -
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First anniversary of PRIME: experience so far
European Medicines Agency, London, UK, 19/05/2017, Last updated: 07/06/2017 -
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News: First anniversary of PRIME – experience so far
Last updated: 22/03/2017 -
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Adaptive pathways
Last updated: 23/02/2017 -
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Adaptive pathways workshop
European Medicines Agency, UK, 08/12/2016, Last updated: 23/02/2017 -
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Press release: Conditional marketing authorisations give patients access to important new medicines earlier
Last updated: 23/01/2017 -
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Press release: Adaptive pathways: key learnings and next steps
Last updated: 03/08/2016 -
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News: First statistics on PRIME are released
Last updated: 01/06/2016 -
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Press release: Launch of PRIME - Paving the way for promising medicines for patients
Last updated: 07/03/2016 -
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Support for early access
Last updated: 09/02/2016 -
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News: Public consultation starts on PRIME - a new scheme to optimise development of priority medicines and facilitate patients' access
Last updated: 26/10/2015 -
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Press release: Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer
CHMP, Last updated: 27/03/2015 -
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News: Adaptive pathways: a future approach to bring new medicines to patients?
Last updated: 15/12/2014 -
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News: Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications
Last updated: 20/11/2018 -
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News: Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published
Last updated: 31/07/2019 -
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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: Workshop on regulatory support for development of orphan medicines
COMP, Last updated: 23/11/2020 -
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News: PRIME enables earlier availability of life-changing medicines
Last updated: 03/03/2022