All European Medicines Agency (EMA) articles
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Industry newsDARWIN EU reaches more than 100 research studies
This industry news update shares a major milestone for DARWIN EU that has reached more than 100 research studies.
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JournalCross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
This article discusses the requirements of clinical data transparency particularly in relation to the EMA Policy 0070 and HC PRCI.
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Industry newsEMA launches #ItTakesATeam campaign to address medicine shortages
This industry news update explains the #ItTakesATeam campaign which aims to raise awareness of medicine shortages.
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Industry newsEMA ETF offers scientific advice for antimicrobial resistance
This is an industry news update about the EMA’s ETF that offers scientific advice for antimicrobial resistance.
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JournalSME1: Regulatory updates for SMEs, academia and start-ups
This is a report of the SME1 session that took place at this year’s Symposium.
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JournalPS1: Tailored development of biosimilars without efficacy and safety studies – Is this the future?
This is a report of the PS1 session that took place at this year’s Symposium.
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JournalPS2: Navigating the green horizon – Environmental sustainability and regulatory affairs
This is a report of the PS2 session that took place at this year’s Symposium.
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JournalHM8: ePI is on FHIR – Preparing for implementation
This is a report of the HM8 session that took place at this year’s Symposium.
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JournalHM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development
This is a report of the HM9 session that took place at this year’s Symposium.
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JournalHM2: Fireside chat
This is a report of the HM2 session that took place at this year’s Symposium.
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ContentsNovember 2025 – Contents: Medical devices/IVD sessions
The November issue of Regulatory Rapporteur reports on the medical devices/IVD sessions from the TOPRA Symposium 2025.
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ContentsNovember 2025 – Contents: Human medicines sessions
The November issue of Regulatory Rapporteur reports on the human medicines sessions from the TOPRA Symposium 2025.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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EditorialTOPRA Symposium 2025: Leading with impact
This issue reports on the human medicine, medical device, IVD and veterinary medicine sessions from the 2025 TOPRA Symposium.
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Industry newsEMA launches #HealthNotHype campaign
This industry news update shares the EMA’s new social media campaign to raise awareness for GLP-1 medicines.
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EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
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ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.
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ContentsSeptember 2025 – Contents
The September issue of Regulatory Rapporteur focuses on product information.
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EditorialReimagining product information
This issue delves into the fundamental role of product information and the processes for its management, and explores how technological advancements are shaping its evolution, with patients’ needs at its core.
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Industry newsEMA publishes workplan on how to harness data and AI for public health
This industry news update discusses the EMA’s workplan on how to use data and AI to improve public health.