All Sustainability articles
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JournalEnvironmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
The 2024 revision of the EU environmental risk assessment (ERA) guideline extended requirements to all new marketing authorisation applications, including generics and hybrids. This article discusses the obstacles in pharmaceutical ERA, and the implications for regulatory efficiency, environmental protection, ethical use and the potential for improved ERA data reuse.
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JournalElectronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
This article discusses the 2018 e-PIL pilot in Belgium and Luxembourg including the paper and electronic versions of the patient information leaflet.
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Journal What could the future of labelling look like? The Gravitate-Health story
This article introduces the Gravitate-Health digital lens concept and talks about the value of ePI to help understand patient needs.
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JournalThe EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
This interview with Juan García Burgos discusses the upcoming EMA/National Competent Authority electronic product information (ePI) initiative.
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JournalProduct information: An overview
This article gives an introduction to product information, how it is created and managed, and the benefits of transitioning to electronic product information labelling.
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JournalTranslating real-world needs into digital medication tools: Good practices for co-creation with patients
This article discusses the importance of patient engagement in digital health tool development, using the case study of the Gravitate-Health project.
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EditorialSustainable pharmaceuticals
Regulatory Rapporteur July/August 2024 | Volume 21 | No.7 In this bumper July/August edition of Regulatory Rapporteur, we focus on sustainability and, in many aspects, we build upon our June theme of access to medicines. Sustainability in pharmaceuticals encompasses ...
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Industry newsViolin resin works as cleaning agent for ‘superbugs’
A form of resin taken from a Norway spruce has been found to also function as an effective disinfectant against drug-resistant bacteria.