All Asia articles
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ContentsRegulatory Rapporteur September 2026 – Contents
The September issue of Regulatory Rapporteur focuses on Asia-Pacific.
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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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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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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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JournalCan the Japanese phase I study be waived?
New guidance: ‘Basic principles for conducting phase I studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan,’ issued in December 2023