All Editorial articles
View all stories of the same content type.
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EditorialAsia-Pacific: A changing regulatory landscape
This issue explores the evolving regulatory landscape across Asia-Pacific, from China’s regulatory reforms and India’s digital and device initiatives to Australia’s evolving pathways and Japan’s gene therapy framework. With a focus on innovation, harmonisation, market access and implementation, it highlights the practical challenges and opportunities shaping regulatory strategies across the region.
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EditorialTherapeutics: Navigating diverse regulatory pathways
This July/August issue of Regulatory Rapporteur explores how regulatory strategies are shaped by the unique demands of different therapeutic areas. From oncology, rare diseases and paediatrics to influenza, fertility and vaccine safety, we examine the evolving pathways, challenges and opportunities facing product development. Together, these articles highlight the critical role regulatory professionals play in navigating complex and often divergent requirements to support innovation and deliver safe, effective therapies to patients worldwide.
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EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
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EditorialThe regulatory profession: Origins, career development and the road ahead
This May issue examines the regulatory affairs career journey, from accidental entry to strategic leadership. Contributors across medical devices, veterinary medicine and pharmaceuticals offer practical guidance for professionals at every stage, exploring skill development, career progression and the competencies that distinguish advancing professionals from those who plateau.
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EditorialAccess to medicines: From approval to
patient-centred deliveryThis issue focuses on access to medicines, and demonstrates how lifecycle regulation, diverse evidence, operational innovation and corss-sector collaboration all contribute to improving the timely, equitable and trusted delivery of medicines.
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EditorialThe innovation era: Where biology meets technology
This issue highlights the rapid evolution of the biologicals landscape and shows why early, transparent regulatory dialogue is now critical to translating scientific breakthroughs into global patient access.
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EditorialMedTech in transition: Regulation, risk and real-world impact
This issue is shaped by a unifying theme: how risk, evidence, inclusivity and innovation are being brought to the forefront by evolving regulatory expectations across the medical device lifecycle.
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EditorialNavigating complexity: Regulation at the interface of innovation, technology and confidence
This issue focuses on complex products, with articles on brain-computer interfaces, radiopharmaceuticals and sophisticated generic products, and explores how regulatory systems can remain robust and predictable while enabling novel technologies to reach patients.
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EditorialNorth America: Transparency, transformation and innovation pathways
This issue focuses on North America, with articles centring on developments in both the US and Canada. It also presents multiple articles on the topic of medical devices and technology.
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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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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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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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EditorialPatient voice: Shaping the future of medicine regulation
This issue looks at the evolving landscape of public and patient involvement (PPI) and how the views of the patient community are being included in research, academia, health and social care and regulatory decision-making.
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EditorialVeterinary medicines: Translating regulation into practice
This issue looks at the impact of the Veterinary Regulation 2019/6, the effect of the new EMA fees on marketing authorisation holders, and the regulatory challenges associated with the practical use of bacteriophages in veterinary medicine.
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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