All Journal articles
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JournalDivergence on the definition of regulatory reliance in international regions: Is there room for convergence?
The article explores how reliance pathways can be used for MAAs and incorporates AstraZeneca’s research findings on this topic.
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JournalMedical device standards update: May 2025
This article updates the progress of applicable medical device standards to May 2025.
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JournalPromoting the use of bacteriophages in animals to reduce antimicrobial resistance
This article explores bacteriophage-based products for animals and how to reduce antimicrobial resistance (AMR).
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JournalSandbox of trust: Regulated AI for health promotion and disease prevention
This article explores the capacity and potential for AI tools in analysing health data and helping with disease prevention.
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JournalNew European Medicines Agency fees: The effect on veterinary medicines
In response to the EMA’s new fee system, this article dicusses the impact on marketing authorisation holders who place veterinary medicines on the market.
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JournalVeterinary Regulation 2019/6: Impact, challenges and the future: Interview with Ivo Claassen
In this interview, Claire McDermott talks with Ivo Classen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency on the impact of Veterinary Regulation 2019/6.
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JournalNavigating orphan drug designation in the EU
Orphan drug designation (ODD) is granted to help with the development of treatement for rare diseases. In this article, ODD’s legal framework and its benefits and challenges are explored.
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JournalNavigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
This article discusses the platform technology designation (PTD) initiative, including its key elements, challenges and its overall significance.
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JournalPrescribing efficiency: Using generative artificial intelligence for pharmacovigilance
Pharmacovigilance stands as a cornerstone of patient safety but the processes can be arduous. This article explores how generative AI can optimise workflows, reduce reporting burdens and improve timeliness.
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JournalCase studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans
This article looks at the impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and uses case studies to help improve ATMP development.
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JournalRecent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
With ATMPs bringing new promise to the treatment of cancer, this article assesses recent clinical developments, how regulators are responding to these advances and how this will impact patient access in the future.
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JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
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JournalRegulatory governance for medical research in the United Arab Emirates: A comprehensive overview
Since the country’s establishment in 1971, the United Arab Emirates (UAE) has strived for the continual progress and prosperity of the country and its people. This is reflected in the constantly improving research regulatory governance framework that encompasses both federal and local requirements. This article provides a comprehensive overview of the UAE’s research governance structure and highlights its requirements and applicable legislation, both at federal and local levels.
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JournalEssential steps for a successful notified body application in medical devices and in vitro diagnostic products
Navigating the notified body (NB) application process is a critical step for manufacturers seeking CE certification for medical devices under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). A well-prepared application can significantly streamline the approval process, reduce delays and ensure compliance with regulatory requirements.
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JournalMaking the move from regulatory affairs: Transferring your skills to the wider pharmaceutical industry
Career development is often discussed and is a personal journey impacted by an individual’s interests and skillset. Having made a transition from regulatory affairs into a commercial role, this article provides a personal reflection on the unique position that regulatory affairs has within a pharmaceutical company, enabling visibility and support across the entire product lifecycle and collaborating with a wide range of functions. The key to moving to roles outside of the regulatory profession is keeping an open mind to available opportunities across the industry.
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JournalDeciphering the regulatory landscape of MENA markets: Challenges in pricing and ancillary issues
The pharmaceutical market in the Middle East and North Africa (MENA) region is growing rapidly, offering vast opportunities for innovation and market expansion. However, navigating the regulatory landscape in this diverse and complex region presents unique challenges that pharmaceutical companies must address in order to create a value proposition.
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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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JournalClinical research in Africa: Regulatory environment, challenges and opportunities
Africa is a destination for clinical research and its developments and growing potential should not be overlooked. There are benefits for those who intend to gain an understanding of the challenges and opportunities on this large and varied continent. Although the diversity of the people, cultures and regulations in Africa has an impact on complexity, there are numerous regulatory and harmonising organisations working to improve efficiencies, many of which require meticulous collaboration.
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JournalImmunological considerations in the development of novel vaccines
Part 1 of this series explored the elements of the immune response that are important to vaccine effectiveness. Part 2 looks at how understanding of the immune response supports prediction of vaccine effectiveness and can optimise clinical development of vaccines. The article then goes on to look at the impact of population diversity.