All Asia-Pacific (APAC) 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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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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