Pharmaceuticals – Page 6
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JournalThe availability of medicines post-Brexit in Malta
Malta has historically sourced medicinal supplies from the UK, but following Brexit insufficient supply of medicines represents a significant obstacle to patients’ access to medicines.
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PodcastsRegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
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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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JournalThe first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract Patients with transfusion-dependent β-thalassemia and severe sickle cell disease suffer the burden of repeated blood transfusions and vaso-occlusive crises, respectively. Casgevy (exagamglogene autotemcel) consists of autologous CD34+ haematopoietic stem ...
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JournalNavigating the process complexities and challenges associated with EU-CTR transition applications
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU ...
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InterviewDr Peter Marks on reflecting innovation through FDA regulation
Harriet Edwards and Dr Katherine Bowen spoke to Dr Peter Marks, Director of Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), about his career and the continued evolvement of regulation to support innovative medicines development
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PodcastsRegRapPod − In Conversation with Helena Corte-Real
BONUS EPISODE: In Conversation talking careers with Helena Corte-Real
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PodcastsRegRapPod − April 2024
Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.
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JournalChoosing the right registration pathway for the China drug master file: an essential analysis of options
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Abstract Building upon the foundational insights presented in the first article of our China series, this subsequent piece delves deeper into the intricacies of China’s drug master file (DMF) ...
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EditorialImproving outcomes with data
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Data, the focus topic for this month’s journal, brings together a range of articles which are underpinned by one uniting factor: our absolute dependence on it. Perhaps, ...
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JournalCan the Japanese phase I study be waived?
New guidance: ‘Basic principles for conducting phase I studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan,’ issued in December 2023
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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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