All Regulatory affairs articles
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Industry newsCVMP advances discussions on AMR and quality guidance
During the April 2026 session, the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) addressed a range of regulatory and scientific topics covering authorised products, pharmacovigilance, antimicrobial resistance (AMR) and ongoing guideline development.
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JournalA career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
This article provides an insight into the career of a regulatory professional in the veterinary sector for those looking to enter the industry, and discusses the personal and professional requirements necessary to succeed in this role.
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JournalRethinking regulatory talent development
Drawing on interviews with experienced regulatory professionals, this article identifies the non-technical competencies associated with advancement to leadership roles and calls for a rethink of the approach to developing these skills.
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JournalCareer growth in medical device regulatory affairs: A recruiter’s perspective
Written from a recruiter’s experience, this article givesinsights into what the hiring market values and offers recommendations for regulatory professionals on how to progress a career in the medical device sector.
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JournalAn accidental profession: Finding your path in medical device regulatory affairs
Drawing on personal experience and industry observations, this article explores how early-career professionals can navigate the medical device regulatory profession and build a rewarding career.
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JournalThe drug development lifecycle: Regulatory milestones and pathways for early-career professionals
Aimed at aspiring or newly appointed regulatory professionals, this article outlines key stages of the drug development lifecycle and highlights the critical role regulators play throughout the process.
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JournalBridging science and compliance: A career path from academia to regulatory medical writing
Aimed at early-career professionals and prospective entrants, this article offers a personal perspective on how academic skills transfer into regulatory practice, supporting the development of a career in regulatory medical writing.
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CommentaryThe future of regulatory affairs: From siloed structures to data-driven healthcare innovation
As biologicals, AI, combination products and personalised therapies continue to reshape healthcare, this article explores what models will define the future of the regulatory affairs profession.
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JournalThe evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
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ContentsRegulatory Rapporteur January 2026 – Contents
The January issue of Regulatory Rapporteur focuses on complex products.
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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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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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JournalFrom laboratory to patient: The role of New Substance Notifications in delivering innovative therapies in Canada
This article explores the new substance notification (NSN) processes and provides guidance on navigating this.
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InterviewGlobal health equity: Inspiring collaboration and harmonisation
Rui Santos Ivo was awarded the prestigious ‘Lifetime Achievement’ Award at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, he discusses his career journey and his thoughts on agencies’ challenges in ensuring global health equity.
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InterviewThe importance and evolving role of regulatory affairs education
Thuy Mason, MPharm Course Director and Senior Lecturer on the BSc Pharmaceutical Science with Regulatory Affairs and the MSc Pharmaceutical Science courses at Kingston University, was a finalist for the ‘Education’ award at the 2024 TOPRA Awards for Regulatory Excellence. In this interview, she discusses the evolution of the courses ...
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InterviewCommunicating with regulatory affairs professionals: The power of the podcast
Harriet Edwards, finalist in the ‘Communication’ award category at the 2024 TOPRA Awards for Regulatory Excellence, talks about Boyds’ podcasts and their benefits as a way of consuming key regulatory information.
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InterviewHow to develop your skills and stand out from the crowd
Michelle Blake, Associate Director and Senior Regulatory Consultant at DLRC Ltd, and winner of the ‘Contribution’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses her career path in regulatory affairs and gives advice on how to develop your skills.
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InterviewHow to inspire a new generation of regulatory professionals
Kate Betteridge, Global Regulatory Portfolio Lead at Pfizer, and winner of the ‘Inspiration’ award at the 2024 TOPRA Awards for Regulatory Excellence, discusses strategies for harnessing innovation and creativity and her role in developing the regulatory professionals of the future.
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JournalA comprehensive analysis of drug pricing mechanisms and the regulatory framework in Morocco
Access to affordable medication is crucial for equitable healthcare systems, but balancing drug pricing and accessibility is challenging. Unaffordable drug prices are a global concern, affecting high-, middle- and low-income countries alike. Understanding drug pricing mechanisms in Morocco is essential for ensuring equitable healthcare access and system sustainability. This article provides a review of pharmaceutical pricing and reimbursement policies in Morocco, traces the historical evolution of drug pricing mechanisms, and explains their role in the drug registration process.
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JournalThe role of artificial intelligence in regulatory affairs
This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.