All Regulatory Rapporteur articles in February 2025
View all stories from this issue.
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JournalRegulatory strategy implications for foetal medicine
Regulation (EC) 1901/2006 is clear that paediatric investigation plans (PIPs) apply to children from birth to 18 years of age, which omits the unborn foetus. To understand whether any recommendations exist which would support seeking agreement on a PIP for this special population, a review of European legislation, guidelines and other application precedents was undertaken. This article summarises the review and provides insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during the review.
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JournalImmunological considerations in the development of novel vaccines
This article explores the critical elements of the immune response that contribute to vaccine effectiveness, with reference to the European Medicines Agency’s (EMA) recent scientific guideline on clinical evaluation of new vaccines.
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JournalAn industry perspective on the use of patient experience data in medicines development: Is further action needed from European regulators?
Engaging with patients to understand their experiences, needs and preferences provides important information to sponsors of medicines development as well as to decision-makers, and integrating this information into every stage of medical product development can significantly enhance the therapeutic landscape for all stakeholders.
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JournalAn introduction to the Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is an International Medical Device Regulatory Forum (IMDRF) scheme whereby the regulatory authorities of member jurisdictions have agreed to subcontract regulatory surveillance of the industry to existing notified bodies (NBs).
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JournalImplications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
The integration of artificial intelligence within healthcare has heralded a new era of innovation for medical devices and in vitro diagnostics. This article explores some implications of the EU’s AI Act for the existing regulatory frameworks governing MDs, specifically the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
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JournalThe EU Medical Device Regulation: Balancing innovation with regulation
The EU Medical Device Regulation (EU MDR) 2017/745 was introduced in response to the need for tighter regulation of medical devices (MDs) in Europe. However, with the increased regulatory burden, there could be potentially hundreds of unanticipated ramifications, particularly for smaller manufacturers and start-ups. By increasing regulation so significantly in a relatively short time period, the very rules which are designed to protect patients may prevent them from accessing the treatment they need and stifle innovation, as start-ups inevitably struggle under the weight of new requirements. This article assesses the delicate balance between innovation and regulation and analyses the relationship between the two.
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PodcastsRegRapPod − InConversation with the UK ePI Task Force
InConversation talks electronic product information with Andrew Burgess and Michael Clarke