213 results
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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Orphan designation: Lenvatinib for: Treatment of hepatocellular carcinoma
Date of designation: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of papillary thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of follicular thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Innovation in medicines (updated)
Last updated: 28/11/2022 -
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Guidance for medicine developers and other stakeholders on COVID-19 (updated)
Last updated: 21/11/2022 -
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PRIME: priority medicines (updated)
Last updated: 16/11/2022 -
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Big data
Last updated: 28/10/2022 -
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Union Product Database: webinar on variations not requiring assessment (VNRAs) for marketing authorisation holders
Online, 10:00 - 11:30 Amsterdam time (CEST), 08/09/2022, Last updated: 27/10/2022 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers
Last updated: 26/10/2022 -
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Plasma master file certificates
Last updated: 20/10/2022 -
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Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making
European Medicines Agency, Amsterdam, the Netherlands, 21/09/2022, Last updated: 17/10/2022 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 14/10/2022 -
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Q&A: Good clinical practice (GCP)
Last updated: 10/10/2022 -
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COVID-19 treatments: research and development
Last updated: 06/10/2022 -
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COVID-19 vaccines: research and development
Last updated: 06/10/2022 -
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Orphans: Regulatory and procedural guidance and forms
Last updated: 30/09/2022 -
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EudraVigilance training and support
Last updated: 23/09/2022 -
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CHMP opinions on consultation procedures
Last updated: 16/09/2022 -
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Eight industry stakeholder platform on research and development support
Online, 11/07/2022, Last updated: 13/09/2022 -
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GMP/GDP Inspectors Working Group
Last updated: 05/08/2022 -
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EudraVigilance: security principles and responsibilities
Last updated: 18/07/2022 -
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Good clinical practice (GCP) inspection procedures
Last updated: 13/07/2022 -
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Maximum residue limit opinions
Last updated: 01/07/2022 -
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Quality of medicines questions and answers: Part 2
Last updated: 01/07/2022