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Publication
Terapias avançadas: enquadramento legal e regulamentar
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| PPG_28169 | 954.71 KB | Adobe PDF |
Advisor(s)
Abstract(s)
Medicamentos de terapia avançada (ATMPs) são medicamentos para uso humano que
têm por base genes, células ou tecidos. Trata-se de um grupo de medicamentos
inovadores, de natureza específica, tanto no seu fabrico, como no mecanismo de ação,
que vêm oferecer novas oportunidades no tratamento de doenças. Estão classificados em
quatro grupos: medicamentos de terapia genética; medicamentos de terapia com células
somáticas; medicamentos de engenharia de tecidos e medicamentos combinados de
terapia avançada.
A necessidade de harmonização legislativa no espaço europeu deve-se, em grande
medida, à natureza complexa e específica destes medicamentos e de obviar a
heterogeneidade existente, quer ao nível das exigências (em que cada Estado-Membro
estabelece um quadro regulamentar próprio), quer ao nível da qualidade dos tratamentos
recebidos.
A presente dissertação tem por objectivo apresentar as terapias avançadas, bem como o
seu enquadramento legal, abordando os principais diplomas que vigoram no espaço
europeu e apresentar os medicamentos atualmente autorizados, suspensos e retirados
pela EMA.
Advanced therapy medicinal products are medicines for human use based on genes, cells or tissues. It is a group of innovative medicines, of specific nature regarding its fabric and as well its mechanism of action, that present new opportunities for treatment of diseases. These medicines are classified in four groups: gene therapy medicinal products; somatic cell therapy medicinal products; tissue engineered medicinal products and combined advanced therapy medicinal products. The need for legislative harmonisation in the european area is, to a great extent, due to the complex and specific nature of these medicines and also to remedy the existing diversity in what concerns legal requirements (each Member State has its own legal framework) and also the quality of the treatments received. The purpose of the present dissertation is to present the legal framework of the advanced therapies, addressing the main legal acts in force on the European area and also to draw its current outlook.
Advanced therapy medicinal products are medicines for human use based on genes, cells or tissues. It is a group of innovative medicines, of specific nature regarding its fabric and as well its mechanism of action, that present new opportunities for treatment of diseases. These medicines are classified in four groups: gene therapy medicinal products; somatic cell therapy medicinal products; tissue engineered medicinal products and combined advanced therapy medicinal products. The need for legislative harmonisation in the european area is, to a great extent, due to the complex and specific nature of these medicines and also to remedy the existing diversity in what concerns legal requirements (each Member State has its own legal framework) and also the quality of the treatments received. The purpose of the present dissertation is to present the legal framework of the advanced therapies, addressing the main legal acts in force on the European area and also to draw its current outlook.
Description
Keywords
Terapias avançadas Terapia genética Terapia com células somáticas Engenharia de tecidos Advanced therapies Genetic therapy Somatic cell therapy Tissue engineering