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A comparative analysis of the ‘drug-device combination’ regulatory aspects in the europe union, USA and Africa
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Abstract(s)
Registou-se um aumento da utilização de combinações fármaco-dispositivo, especialmente com a
aumento recente das inovações nas tecnologias da saúde, devido à necessidade crescente de
direcionamento medicamentoso, administração local e terapia individualizada. Estas combinações são
Especialmente benéfico para pacientes que sofrem de doenças potencialmente fatais, tais como: múltiplas
esclerose, cancro, malformações congénitas, diabetes e muito mais. Este aumento
A complexidade das tecnologias de saúde levou a complexidades ainda maiores na
e, por isso, há necessidade de comparar a regulamentação destes
tecnologia de saúde em todo o mundo para impulsionar o desenvolvimento de processos e, em seguida, impulsionar seus primeiros
acesso aos doentes que deles necessitam, promover a inovação e reduzir a duplicação de trabalho. Esta tese tem como objetivo comparar como as combinações fármaco-dispositivo são reguladas em vários
agências reguladoras na União Europeia (UE), nos EUA e em África. Esta pesquisa foi
realizada através da recolha de dados através da consulta a diferentes agências reguladoras e
motores de pesquisa de dados. A análise dos dados recolhidos resultou na descoberta de várias formas
através do qual a regulação das combinações medicamentosas e dispositivos pode ser melhorada em toda a
diferentes agências reguladoras envolvidas. Na UE, a combinação é regulamentada como um medicamento ou um dispositivo, dependendo do seu
modo de ação primário (PMOA), assegurando ao mesmo tempo que a outra parte está em conformidade com
normas regulatórias, nos EUA, a FDA atribui um centro para lidar com sua regulamentação
dependendo do PMOA, o centro designado consulta outros centros quando e se necessário.
Na África, há uma série de órgãos reguladores, portanto, a regulamentação é menos padronizada. Embora algumas entidades reguladoras regulem as diferentes partes separadamente, independentemente da
PMOA, alguns outros regulam dependendo do PMOA percebido da combinação
produto.
Para exemplificar as diferentes vias regulatórias foram discutidos dois estudos de caso:
Preservativo espermicida e escova dopada com Fe. Esta tese analisou os dois fármacos-dispositivos
produtos combinados, detalhando como são regulamentados nas regiões estudadas. Ambos são
produtos que podem colocar desafios regulamentares únicos, sendo que pode ser difícil
determinar o PMOA exato e pode ser regulado, dependendo da região em um caso-a-caso
base casuística. As conclusões indicam que as diferentes entidades reguladoras nas diferentes regiões
dispor de diferentes métodos para regular o processo de combinação fármaco-dispositivo e
Se adotarmos um método específico nas diferentes regiões, haverá o
Possibilidade de harmonizar a regulamentação até ao ponto de uma comercialização única
autorização emitida por qualquer uma das regiões seria tudo o que é necessário para colocar o produto
no mercado nestas regiões. Tal reduzirá a carga dos processos regulamentares, poupando
tempo e recursos e levar a um acesso mais precoce aos pacientes que deles necessitam.
There has been an increase in the use of drug-device combinations, especially with the recent rise in health technology innovations, because of the increasing need for precise drug targeting, local administration and individualized therapy. These combinations are especially beneficial for patients suffering from life threatening diseases such as: multiple sclerosis, cancer, congenital malformations, diabetes and many more. This increasing complexity in health technology has led to even greater complexities in the regulatory requirements and because of this there is need to compare the regulation of these unique health technology across the globe to drive process development and then drive their early access to patients who need them, foster innovation and reduce duplication of work. This thesis aims to compare how drug-device combinations are regulated across several regulatory agencies in the European Union (EU), the USA and Africa. This research was carried out by collecting data through the consulting different regulatory agencies and data search engines. Analysis of data collected resulted in a discovery of various ways through which the regulation of drug-device combinations can be improved across the different regulatory agencies involved In the EU, the combination is regulated as either a drug or a device depending on their primary mode of action (PMOA), while ensuring that the other part conforms with regulatory standards, in the USA, the FDA assigns a center to handle their regulation depending on the PMOA, the assigned center consults other centers when and if need be. In Africa, there are a number of regulatory bodies, thus the regulation is less standardized. While some regulatory bodies regulate the different parts separately, regardless of the PMOA, some other regulate depending on the perceived PMOA of the combination product. ii To exemplify the different regulatory pathways two case studies were discussed: Spermicide condom and Fe-doped brushite. This thesis analyzed the two drug-device combination products, detailing how they are regulated in the regions studied. Both are products that may pose unique regulatory challenges, being that it may be difficult to ascertain the exact PMOA and may be regulated, depending on the region on a case-by case basis. Findings made indicate that the different regulatory bodies across the different regions have different methods through which to regulate drug-device combination process and if we adopt a particular method across the different regions, then there would be the possibility of harmonizing the regulations to the point where a single marketing authorization issued by any of the regions would be all that is required to place the product in the market in these regions. This will reduce the burden of regulatory processes, save time and resources and lead to earlier access to the patients who are in need of them.
There has been an increase in the use of drug-device combinations, especially with the recent rise in health technology innovations, because of the increasing need for precise drug targeting, local administration and individualized therapy. These combinations are especially beneficial for patients suffering from life threatening diseases such as: multiple sclerosis, cancer, congenital malformations, diabetes and many more. This increasing complexity in health technology has led to even greater complexities in the regulatory requirements and because of this there is need to compare the regulation of these unique health technology across the globe to drive process development and then drive their early access to patients who need them, foster innovation and reduce duplication of work. This thesis aims to compare how drug-device combinations are regulated across several regulatory agencies in the European Union (EU), the USA and Africa. This research was carried out by collecting data through the consulting different regulatory agencies and data search engines. Analysis of data collected resulted in a discovery of various ways through which the regulation of drug-device combinations can be improved across the different regulatory agencies involved In the EU, the combination is regulated as either a drug or a device depending on their primary mode of action (PMOA), while ensuring that the other part conforms with regulatory standards, in the USA, the FDA assigns a center to handle their regulation depending on the PMOA, the assigned center consults other centers when and if need be. In Africa, there are a number of regulatory bodies, thus the regulation is less standardized. While some regulatory bodies regulate the different parts separately, regardless of the PMOA, some other regulate depending on the perceived PMOA of the combination product. ii To exemplify the different regulatory pathways two case studies were discussed: Spermicide condom and Fe-doped brushite. This thesis analyzed the two drug-device combination products, detailing how they are regulated in the regions studied. Both are products that may pose unique regulatory challenges, being that it may be difficult to ascertain the exact PMOA and may be regulated, depending on the region on a case-by case basis. Findings made indicate that the different regulatory bodies across the different regions have different methods through which to regulate drug-device combination process and if we adopt a particular method across the different regions, then there would be the possibility of harmonizing the regulations to the point where a single marketing authorization issued by any of the regions would be all that is required to place the product in the market in these regions. This will reduce the burden of regulatory processes, save time and resources and lead to earlier access to the patients who are in need of them.
Description
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2024, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Regulation Drug-device combinations Innovation Process development Harmonization Teses de mestrado - 2024