All Genetically modified organism (GMO) 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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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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JournalHM9: From barrier to bridge – Practical strategies for successful advanced therapy medicinal product (ATMP) development
This is a report of the HM9 session that took place at this year’s Symposium.
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JournalPS2: ATMP innovations and clinical trials with genetically modified organisms
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jayne Hunt, Principal Regulatory Affairs Consultant, Ariello. Speakers: Patrick Ginty, Boyds Consultants. Isabel Borba Vieira, Nonclinical Assessor at Medicines Evaluation Department Scientific Evaluation Unit, ...
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PodcastsRegulating Vaxzevria
Vol. 20 #4
MEMBER EXCLUSIVE:
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]. Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria. -
JournalEvolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR
The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs).
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EditorialMind the gap:
Innovation vs
regulation of ATMPsTechnology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.