Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States

Ivaškienė, Tatjana; Mauricas, Mykolas; Ivaška, Justinas

doi:10.2174/1574888x11666160714114854

Cited by 15 publications

(14 citation statements)

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“…Moreover, it is not possible to use ATMP authorized under hospital exemption for clinical experimental use. Despite the absence of any publicly available database on the application of hospital exemption in Europe, our impression and personal experience is that this activity is still marginal and its effect is negligible [3].…”

Section: Our History and Authorizationmentioning

confidence: 94%

“…These products in Europe are regulated by the general rules of medicinal products and therefore are governed, by the same specific legislation as industrially produced drugs, with the sole exclusion of the products falling under the so-called 'hospital exemption' (article 28 of EC no. 1394/2007) that are issued on a national specific basis [2,3]. In enforcement of the European regulation 1394/2007, all ATMP must be prepared according to GMP and be in compliance with investigational medicinal product or marketing authorization requirements and postmarketing pharmacovigilance rules.…”

mentioning

confidence: 99%

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Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

2017

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Advanced therapy medicinal products represent a new generation of medicinal products for regenerative medicine. Since the implementation of the EU regulation for this innovative class of drugs, the academic and hospital institutions have played a central role in their development and manufacture. For these institutions that are not familiar with the industrial context, being in compliance with the pharmaceutical standards is extremely challenging. This report describes how we dealt with some specific issues during our hospital-based GMP experience. Furthermore, we identify as a future perspective the consistent stimulating contribution that a public entity can ensure for advanced therapy medicinal product development and licensing.

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Section: Our History and Authorizationmentioning

confidence: 94%

mentioning

confidence: 99%

Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

2017

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“…The HE is a European-specific scheme that grants approval for use of medical products on an experimental basis in specific hospitals, even though the effectiveness of such products remains to be confirmed. 23 Chondrosphere® was also approved by EMA in July 2017 and marketed as Spherox (Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

Trends in clinical trials for articular cartilage repair by cell therapy

et al. 2018

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Focal and degenerative lesions of articular cartilage greatly reduce the patient’s quality of life. Various therapies including surgical treatment have been developed, but a definitive therapy is not yet known. Several cell therapy products have already been developed and are available in the market. In this study, we examined the clinical research trends related to cell therapy products in the cartilage repair field based on data obtained from the ClinicalTrial.gov website. Although this website does not provide comprehensive results of clinical trials, it offers information on prospective clinical trials, including work in progress, and thus allows for chronological analysis of the data. We selected 203 studies related to the field of cartilage regeneration from ClinicalTrial.gov. The results showed a shift in the clinical translational trend in utilized cells from cartilage- and bone marrow- to adipose tissue-based cells. Whereas the studies that used cartilage as the cell source included many phase III trials, fewer studies using bone marrow and adipose tissue cells progressed to phase III, suggesting that most clinical developments using the latter sources have not been successful so far. One product covered the entire period from the start of phase I to the completion of phase III, with a time to completion of more than 100 months. Translational trends in autologous chondrocyte implantation were also discussed. The use of ClinicalTrials.gov as the sole data source can yield a perspective view of the global clinical translational trends, which has been difficult to observe up to this point.

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“…A isenção hospitalar é bastante controversa e é aplicada de modo muito heterogêneo entre os Estados Membros da UE. Os críticos consideram que ela produz uma competência injusta, promove um mercado fragmentado e que também gera dúvidas em relação à segurança dos pacientes recrutados nos hospitais (IVASKIENE et al, 2017). Debate-se sobre a aplicação para usos não homólogos das TC testadas, acerca de qual seria o número limite de pacientes para a utilização de igual protocolo clínico, em relação à qual é o número mínimo de sítios de manufatura não industrial autorizados, assim como, o fato da medida ter sido caracterizada como prática 'não de rotina ' (CORBETT et al, 2017).…”

Section: Flexibilidades Nas Licenças Dos Ensaios Clínicosunclassified

Governança global, regulamentação flexível e os ensaios clínicos na medicina regenerativa no Reino Unido e na União Europeia

Acero

2020

Physis

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Resumo A medicina regenerativa encontra-se em fase de desenvolvimento dos ensaios clínicos em terapias celulares (TC), na sua manufatura e na sua adoção gradual dentro dos sistemas de saúde. Entretanto, há uma série de lacunas e contradições na governança e regulamentação na área e o objetivo principal deste artigo é sua discussão dentro das tendências globais, já que esses processos afetam de modo substantivo a saúde coletiva global e encontram-se ainda escassamente resolvidos. O texto foca nos processos prevalentes nos ensaios clínicos com TC em duas lideranças internacionais, o Reino Unido e a União Europeia, utilizando a análise bibliográfica e de conteúdo. O texto conclui com uma discussão das principais vantagens e desvantagens para a saúde coletiva global da transição de um modelo científico de comprovação das novas terapias celulares para, eventualmente, outro baseado na inovação médica ou clínica. O último procede desde a fase pré-clínica com animais à aplicação das novas terapias a grupos pequenos de pacientes e, logo a seguir, a sua inserção no mercado. Muitas vezes, esse modelo se associa a flexibilidades regulatórias, a serem ilustradas no artigo, e especialmente desenhadas para aumentar a rapidez no desenvolvimento e aplicação das terapias.

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Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States

Cited by 15 publications

References 0 publications

Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

Trends in clinical trials for articular cartilage repair by cell therapy

Governança global, regulamentação flexível e os ensaios clínicos na medicina regenerativa no Reino Unido e na União Europeia

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