All Journal articles
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JournalChina’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
China’s VBP programme is significantly reshaping medical device market access. This article examines its regulatory framework, intersection with industrial policy and the strategic options available to foreign manufacturers.
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JournalRegulatory reforms in China: Strengthening excipient quality and accession to PIC/S
This article explores new initiatives in China to strengthen the quality supervision of pharmaceutical excipients and pharmaceutical packaging materials.
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JournalFrom regulation to implementation: Medical device serialisation and traceability in India
This article critically examines the regulatory evolution of medical advice traceability and structured device identification in India, the implementation challenges encountered and the role of GS1 in advancing standardisation.
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JournalModernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment
This article examines India’s regulatory modernisation initiatives and its eCTD 4.0 adoption roadmap. It considers the challenges involved and makes evidence-based recommendations to stakeholders planning a similar transition.
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JournalNavigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations
This article introduces the SYNAPSE Model, a new practical framework which offers a structured approach to orchestrating multiple interdependent PMDA consultations as a coherent regulatory strategy rather than isolated activities.
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JournalManaging ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
This article reviews three post-approval CMC challenge areas in ATMP development: ongoing data commitments, comparability requirements for manufacturing process changes and variation classification, and proposes a five-point framework intended for practical use within the current Asia-Pacific regulatory environment
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JournalNavigating the Australian Office of the Gene Technology Regulator: A regulatory affairs perspective on clinical trials involving genetically modified organisms
This article provides a background to the OGTR’s role in overseeing the use of GMOs in clinical trials, the licence application process, different types of licences and conditions associated with each.
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JournalPathways to medicine registration in Australia
This article covers the pathways that can be followed to register a prescription medicine in Australia: the standard registration pathway, the priority review pathway, the provisional determination pathway, the comparable overseas regulators report-based pathway, the Access Consortium pathway and Project Orbis. It examines each registration pathway, including scope and evaluation time.
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JournalMedical device standards update: July 2026
This article is a continuation of previous updates that share medical device standards up to July 2026.
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JournalDrug development and regulatory pathways across therapeutic areas
This article evaluates how drug development and regulatory pathways differ across oncology, rare diseases, paediatric indications and life-threatening conditions in the US, UK and EU. Drawing on regulatory guidance and industry practices, it explores how therapeutic context shapes development, trial design and approval strategies, highlighting key differences in regulatory expectations and acceleration incentives.
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JournalNavigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
Adverse events following immunisation (AEFI) are a major concern for vaccine safety and public trust. This article examines the current regulatory systems for AEFI surveillance, reporting and causality evaluation, highlights challenges including underreporting and inconsistent frameworks, and assesses how real-world data and advanced analytics could strengthen post-marketing safety surveillance.
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JournalThe development of novel influenza drugs: Current regulatory challenges
Traditionally, influenza product development has focused on vaccines and antivirals. In recent years, novel approaches including monoclonal antibodies and conjugate products have emerged. This article discusses the current challenges in developing new influenza compounds and the potential regulatory avenues that could support these therapies.
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JournalAdvancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction
This article examines the evolution of fertility therapeutics from urinary-derived gonadotropins to recombinant biologics, and the scientific and operational challenges of fertility drug development. It discusses emerging opportunities across the reproductive pathway and how progress will depend on aligning biological innovation with appropriate clinical endpoints, regulatory frameworks and patient-centred outcomes.
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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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JournalEnhancing post-market surveillance with Artificial Intelligence and predictive analytics
Fragmented data and manual review can limit the impact of PMS. Find out more about how AI, can modernise PMS workflows to improve early issue detection and support corrective actions, using a 20-year analysis of arthroscopic-device recalls to illustrate predictive analytics in practice.
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JournalConsiderations in building and maintaining regulatory intelligence
Rising regulatory volume, cross-jurisdictional variation and resource pressures make regulatory intelligence increasingly critical. Explore how AI and technology can support smarter monitoring, planning and risk management.
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JournalFrom gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Rapid advances in AI, software and drug discovery are reshaping regulation. This article challenges the view that regulation hinders innovation, framing it as a collaborative, risk-based partnership with real-world examples from AI diagnostics, in silico methods and medical device tools.
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JournalDriving efficiencies in global submissions through RIMS: Practical perspectives from industry
Manual processes are holding many teams back. Using a case study on complex EU procedures, this article explores how RIMS can help build future-ready regulatory functions.
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JournalNavigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
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JournalThe use of CEPs for API registration when global regulatory implementation pathways are not aligned
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.