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Modos de convergência regulamentar entre medicamentos e dispositivos médicos no quadro da União Europeia
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Resumo(s)
Os dispositivos médicos têm como principais funções auxiliar no diagnóstico,
prevenção, controlo e tratamento de deficiências, doenças ou lesões, contribuindo para uma
significativa melhoria da qualidade de vida da população. Tornam-se, assim, indispensáveis
para o setor da saúde. Por serem tão distintos dos medicamentos e considerando a evolução
que sofreram nos últimos anos, todas as classes de dispositivos médicos têm de ser
abrangidas por legislação própria atualizada, por forma a evitar erros na regulamentação de
produtos potencialmente danosos.
Atualmente, a convergência tecnológica entre dispositivos médicos e outros produtos
de saúde é alvo de grande procura por parte da indústria farmacêutica, criando uma lacuna
legislativa crítica que pode colocar em causa a segurança e eficácia das terapêuticas
comercializadas no mercado da União Europeia.
Por forma a salvaguardar a evolução do setor da inovação, é crítico que existam
estruturas e programas de apoio que possam conduzir os fabricantes na interpretação da atual
legislação. Simultaneamente, a capacitação e formação dos especialistas que integram as
agências reguladoras sobre procedimentos de avaliação de produtos-fronteira permite maior
celeridade no acesso do doente à inovação.
Medical devices main functions include assisting with the diagnosis, prevention, control and treatment of disabilities, diseases or injuries, contributing for a significant improvement in the population’s quality of life. This way, they become paramount for the health sector. Because they’re so different from medicine and taking into consideration the evolution suffered in the past few years, all medical devices’ classes must be covered by their own updated legislation, in order to avoid making mistakes in the regulation of potentially harmful products. Nowadays, the technological convergence between medical devices and other health products has been very sought after by the pharmaceutical industry, creating a severe legislative gap which might jeopardize the safety and efficacy of the therapeutics commercialized in the European Union’s market. As a way of safeguarding the evolution of the innovation sector, the existence of support structures and programs which will guide manufacturers in the interpretation of the current legislation, is critical. Simultaneously, ensuring the qualification and training of the specialists which are a part of the regulatory agencies, regarding evaluation procedures of borderline products will speed the patient’s access to innovation.
Medical devices main functions include assisting with the diagnosis, prevention, control and treatment of disabilities, diseases or injuries, contributing for a significant improvement in the population’s quality of life. This way, they become paramount for the health sector. Because they’re so different from medicine and taking into consideration the evolution suffered in the past few years, all medical devices’ classes must be covered by their own updated legislation, in order to avoid making mistakes in the regulation of potentially harmful products. Nowadays, the technological convergence between medical devices and other health products has been very sought after by the pharmaceutical industry, creating a severe legislative gap which might jeopardize the safety and efficacy of the therapeutics commercialized in the European Union’s market. As a way of safeguarding the evolution of the innovation sector, the existence of support structures and programs which will guide manufacturers in the interpretation of the current legislation, is critical. Simultaneously, ensuring the qualification and training of the specialists which are a part of the regulatory agencies, regarding evaluation procedures of borderline products will speed the patient’s access to innovation.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2020, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Dispositivo médico Medicamento Convergência Enquadramento regulamentar Inovação tecnológica Mestrado integrado - 2020