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Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries [PDF]
Cytotherapy, 2020 Background aims: As part of the advanced therapy medicinal product (ATMP) regulation, the hospital exemption (HE) was enacted to accommodate manufacturing of custom-made ATMPs for treatment purposes in the European Union (EU). However, how the HE pathway
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The Magistral Preparation of Advanced Therapy Medicinal Products (ATMPs)
Journal of Surgery and Practice, 2020Advanced Therapy Medicinal Products (ATMPs) embody innovative therapies that have created great hope for patients suffering from previously untreatable diseases. Unfortunately, the pharaonic cost to produce and authorise ATMPs is a challenge for both patients and public health care systems, ultimately reducing patients’ access to treatment.
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First External Quality Assurance (EQA) Programme for Advanced Therapy Medicinal Products (ATMPs)
Cytotherapy, 2020Background & Aim Quality controls used for ATMPs remain at an early stage of development and, given the intrinsic nature of the specific cell-based preparations, are subject to human factor issues without technical standardization. During the evaluation of marketing authorization applications (MAAs), “major objections” relative to suitable quality and
A. Rodriguez +4 more
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Advances in experimental medicine and biology, 2015
With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory.
Paula, Salmikangas +8 more
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With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory.
Paula, Salmikangas +8 more
openaire +4 more sources
Advanced therapy medicinal products (ATMPs)
Abstract The EU and UK regulatory framework for ATMPs is described alongside the concepts of ATMP classification and hospital exceptions. An example of the role of a not-for-profit organization in the development of ATMPs in the UK is included.Phil Ambery +2 more
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International Journal of Technology Assessment in Health Care, 2020
IntroductionAdvanced Therapy Medicinal Products (ATMPs) are innovative biologics (gene, cells and tissue-based products) with the potential to treat diseases with significant unmet clinical need. ATMPs pose distinct regulatory, health technology assessment (HTA) and patient access challenges, hence early identification and prioritization of ATMPs is ...
James Woltmann +3 more
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IntroductionAdvanced Therapy Medicinal Products (ATMPs) are innovative biologics (gene, cells and tissue-based products) with the potential to treat diseases with significant unmet clinical need. ATMPs pose distinct regulatory, health technology assessment (HTA) and patient access challenges, hence early identification and prioritization of ATMPs is ...
James Woltmann +3 more
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The economics of manufacturing clinical-grade advanced therapy medicinal products (ATMPs)
2014In addition to conventional drugs and biologicals, advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which include - amongst others - somatic cell therapeutics. As the final product is intended for administration into humans, manufacturers of ATMPs are obligated to apply good manufacturing practice (GMP) standards
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Regulatory safety aspects of advanced therapy medicinal products (ATMPs)
2020Advanced therapy medicinal products (ATMPs) such as gene-, cell- and tissue engineered therapies offer tremendous potential for treating unmet medical needs. Due to the novelty, complexity and technical specificity of such products, specially tailored and harmonized rules are needed to evaluate their safety and efficacy.
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POSA265 HTA Requirements for Advanced Therapy Medicinal Products (ATMPS) in Germany
Value in Health, 2022J Dose +5 more
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What are the Changes in 2023 for Access to Advanced Therapy Medicinal Products (ATMPs) in France?
European Journal of Health LawAbstract ATMPs are the most expensive innovative treatments, thus they require special regulation. Past regulatory measures in France, such as limiting the growth of drug expenditures, the creation of a fund to finance pharmaceutical innovation, the use of performance-based contracts and greater emphasis on medico-economic evaluations in pricing have ...
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