All European Medicines Agency articles
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Industry newsContraindication for mixing weight loss medicine Mysimba with opioids
The European Medicines Agency (EMA) published new advice in July 2024 concerning the combined use of opioid medications and the weight loss drug Mysimba (naltrexone/bupropion).
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JournalThe worldwide acceptance of non-legalised eCPPs
The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...
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JournalDigital and data-driven: information management at the EMA
Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for information management legislation
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 2)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1–2 June 2021 as a virtual event with more than 500 participants globally connected. This is the second and final part of the meeting report; the first half was published in Volume 19 No. 1 of Regulatory Rapporteur.
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FocusClinical Trial Information System: overview, opportunities and challenges
The implementation of the Clinical Trial Information System (CTIS), from 31 January 2022, will facilitate the day-to-day business of sponsors of clinical trials by harmonising submission and maintenance of trial applications, assessment and supervision of trials, while promoting patient safety and transparency…
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Meeting ReportVM5: Post-authorisation under Regulation 2019/6
Dries Minne opened the final session of the Veterinary Medicines Symposium 2021, covering changes to post authorisation procedures under Regulation 2019/6.
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Meeting ReportHM3: Evolution of EMA-EUnetHTA collaboration across decision makers
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
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Meeting ReportHM1: Spotlight on CEE – challenges and opportunities in the region
The first session of this virtual symposium was opened by Eva Kopecna, who introduced three speakers, two of whom represented two different regulatory agencies – the Czech State Institute for Drug Control (SÚKL), which is part of the EU regulatory community, and the Russian State Institute of Drugs and Good Practices (SID&GP).
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JournalKey steps and considerations of the EU centralised procedure
This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).