All EMA articles – Page 2
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JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]
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Meeting ReportThe EMA’s Veterinary Big Data Stakeholder Forum (Part 1)
The Veterinary Big Data Stakeholder Forum, the first event of its kind and jointly organised by the European Medicines Agency and Heads of Medicines Agencies, took place on 1 and 2 June 2021 as a virtual event with over 500 participants globally connected.
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Meeting ReportMD5: Innovation in Drug-Device Combinations
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
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Meeting ReportHM4: Real world evidence in regulatory decision-making
During the first part of the session, Fred Senatore discussed applications and the challenges of real word data (RWD) and real-world evidence (RWE). He opened his talk with a definition of the two, with RWD being defined as the data collected from a variety of sources, and RWE as the analysis of the source.
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CPD SupplementDigital health technologies – an overview of EU and US frameworks
Digital health technologies have revolutionised the global healthcare system. This continuing professional development supplement provides an overview of the qualification frameworks for digital health technologies, which are used as drug development tools in the EU and the US.
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CPD SupplementUnderstanding the basics of ATMP regulation
Advanced therapy medicinal products (ATMPs) are biological products which comprise a diverse group of medicinal products that are often complex and diverse in nature. As these products are regularly developed for diseases of high unmet need, the requirements for evidence generation to support marketing authorisation often require innovative development plans. Within this continuing professional development supplement we investigate the regulation of ATMPs in the EU and US [see also Regulatory Rapporteur October 2020 and February 2020 for articles by Harriet Edwards on ATMPs].
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JournalGene therapy: regional assessment comparison
Axicabtagene ciloleucel (tradename YESCARTA) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets CD19 and is approved for the treatment of aggressive, relapsed or refractory forms of B-cell non-Hodgkins lymphoma (NHL). The active substance is composed of a patient’s cells that have undergone ex vivo modification, which causes ...
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JournalGlobal regulatory frameworks for the development of gene therapy products
Gene therapies have the potential to revolutionise the global healthcare system. Some of these products may offer curative benefits to patients with devastating conditions. This continuing professional development (CPD) supplement provides an overview of the regulatory framework for the development of gene therapy products in key markets.
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CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.
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JournalKey steps and considerations of the EU centralised procedure
This continuing professional development article aims to provide some of the background and key steps and considerations when using and navigating the EU centralised procedure for a new marketing authorisation application (MAA).
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