All Advanced therapy medicinal product (ATMP) articles
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JournalICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
This article looks at the new ICH Q1 stability guidance and its various approaches to help promote innovation.
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JournalCase studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans
This article looks at the impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and uses case studies to help improve ATMP development.
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JournalRecent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
With ATMPs bringing new promise to the treatment of cancer, this article assesses recent clinical developments, how regulators are responding to these advances and how this will impact patient access in the future.
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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JournalConsiderations in the development of allogenic and autologous cell therapies
Autologous cell therapy involves the use of a patient’s own cells which are harvested, modified or expanded ex vivo and then reintroduced into the patient. Allogeneic therapies use cells from a donor modified or expanded ex vivo and then administered to the patient.
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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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JournalInnovating and harmonising access and requirements amid the global regulatory challenges of biologics
This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...
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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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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).