All Advanced therapy medicinal products (ATMPs) articles
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ContentsNovember 2025 – Contents: Medical devices/IVD sessions
The November issue of Regulatory Rapporteur reports on the medical devices/IVD sessions from the TOPRA Symposium 2025.
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ContentsNovember 2025 – Contents: Human medicines sessions
The November issue of Regulatory Rapporteur reports on the human medicines sessions from the TOPRA Symposium 2025.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
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ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.
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Industry newsEMA accepts new guidelines on investigational ATMPs
The European Medicines Agency (EMA) has adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which officially comes into effect on 1 July 2025.
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PodcastsRegRapPod − May 2024
Vol.21 #5: In May 2024’s RegRapPod, host Alan Booth talks to Issue Editor Harriet ‘Podcast’ Edwards about her specialist subject ATMPs.
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EditorialUnlocking a new paradigm of healthcare through advanced therapies
Regulatory Rapporteur May 2024 | Volume 21 | No.5 It seems like a recurring theme to start our advanced therapy medicinal products (ATMPs) issue with a familiar message: we are undoubtedly entering a new paradigm of ...
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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.