All Advanced therapy medicinal products (ATMPs) articles
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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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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.
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PodcastsRegRapPod – May 2023
Vol. 20 #5
In this episode of RegRapPod, host Alan Booth, the managing editor of Regulatory Rapporteur, hears from May’s Issue Editor, Harriet Edwards, about the rapid developments in advanced therapy medicinal products and the tensions that arise between regulation and innovation. -
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. -
JournalG-E-T-ting there – how gene editing technologies could change more than genes
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
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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.
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JournalAn overview of the regulatory framework for advanced therapies
Advanced therapy medicinal products (ATMPs) have recently advanced in development and are subject to regulation in some markets. This article summarises the regulatory framework for ATMPs in some of the markets where these requirements are in place: Argentina, Brazil, Europe, and the US.