Loading...
Publication
Aspetos regulamentares da autorização de introdução no mercado dos medicamentos utilizados no tratamento e prevenção da COVID-19
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 1.17 MB | Adobe PDF |
Authors
Advisor(s)
Abstract(s)
A atual pandemia da doença provocada pelo coronavírus 2019 (COVID-19) tem
desafiado a saúde pública, provocando grandes impactos sociais, económicos, culturais
e políticos. Este cenário de emergência levou investigadores, autoridades competentes
de medicamentos e de saúde, indústrias farmacêuticas e governação política a
mobilizarem-se de modo a dar resposta ao aumento rápido e acentuado de infeções,
internamentos e óbitos.
Com base nas considerações anteriores, os objetivos principais desta Dissertação
foram os seguintes: i) analisar a resposta à pandemia de COVID-19 das diversas
entidades envolvidas na avaliação e regulação de medicamentos, tais como a Comissão
Europeia, a Agência Europeia de Medicamentos (EMA) e a Direção Europeia da
Qualidade dos Medicamentos e Cuidados de Saúde; ii) descrever o processo
regulamentar de desenvolvimento, avaliação, autorização e pós-comercialização dos
medicamentos utilizados no tratamento e prevenção da COVID-19; e iii) comparar as
metodologias regulamentares implementadas, no que respeita ao processo de
autorização de introdução no mercado (AIM) de medicamentos, entre a EMA e a
Administração de Alimentos e Medicamentos (FDA) durante a pandemia de COVID-19.
Concluiu-se que, a nível mundial, foram realizados diversos esforços que
permitiram a aprovação de medicamentos (com uma relação benefício/risco positiva)
em tempo recorde, cumprindo-se toda a legislação e enquadramento regulamentar
associados, e sem comprometer a sua qualidade, segurança e eficácia. Das diversas
iniciativas adotadas, destacam-se, por exemplo, o procedimento de revisão contínua, o
aconselhamento científico rápido através do estabelecimento de grupos de trabalho e
a adoção de medidas regulamentares de flexibilidade para a rotulagem e embalagem.
Atualmente (31 de agosto de 2022), estão autorizados na União Europeia diversos
medicamentos para prevenir e tratar a COVID-19. A título de exemplo, salientam-se as
seis vacinas disponíveis (Comirnaty®, Nuvaxovid®, Jcovden®, Spikevax®, vacina contra a
COVID-19 Valneva® e Vaxzevria®) e alguns fármacos como o remdesivir (Veklury®), o
sotrovimab (Xevudy®) e o regdanvimab (Regkirona®).
The current pandemic of the disease caused by coronavirus 2019 (COVID-19) has challenged public health, causing major social, economic, cultural, and political impacts. This emergency scenario has prompted researchers, competent medicines and health authorities, pharmaceutical industries, and political governance to mobilize to respond to the sudden and sharp increase in infections, hospitalizations, and deaths. Based on the previous considerations, the main objectives of this Dissertation were the following: i) to analyse the response to the COVID-19 pandemic of the various entities involved in the evaluation and regulation of medicines, such as the European Commission, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & Health Care; ii) to describe the regulatory process for the development, evaluation, authorization and post-marketing of medicines used in the treatment and prevention of COVID-19; and iii) to compare the regulatory methodologies implemented, with regard to the marketing authorization process for medicines between the EMA and the Food and Drug Administration (FDA) during the COVID-19 pandemic. It was concluded that, worldwide, several efforts were performed that allowed the approval of medicines (with a positive benefit/risk ratio) in record time, complying with all associated legislation and regulatory framework, and without compromising their quality, safety, and efficacy. For example, among the several implemented initiatives, the rolling review process, the rapid scientific advice through the establishment of working groups and the adoption of regulatory flexibility measures for labelling and packaging can be highlighted. Currently (August 31, 2022), several medicines are authorized in the European Union to prevent and treat COVID-19. For instance, the six available vaccines (Comirnaty®, Nuvaxovid®, Jcovden®, Spikevax®, COVID-19 vaccine Valneva® and Vaxzevria®) and some drugs, such as remdesivir (Veklury®), sotrovimab (Xevudy®) and regdanvimab (Regkirona®), can be emphasized.
The current pandemic of the disease caused by coronavirus 2019 (COVID-19) has challenged public health, causing major social, economic, cultural, and political impacts. This emergency scenario has prompted researchers, competent medicines and health authorities, pharmaceutical industries, and political governance to mobilize to respond to the sudden and sharp increase in infections, hospitalizations, and deaths. Based on the previous considerations, the main objectives of this Dissertation were the following: i) to analyse the response to the COVID-19 pandemic of the various entities involved in the evaluation and regulation of medicines, such as the European Commission, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & Health Care; ii) to describe the regulatory process for the development, evaluation, authorization and post-marketing of medicines used in the treatment and prevention of COVID-19; and iii) to compare the regulatory methodologies implemented, with regard to the marketing authorization process for medicines between the EMA and the Food and Drug Administration (FDA) during the COVID-19 pandemic. It was concluded that, worldwide, several efforts were performed that allowed the approval of medicines (with a positive benefit/risk ratio) in record time, complying with all associated legislation and regulatory framework, and without compromising their quality, safety, and efficacy. For example, among the several implemented initiatives, the rolling review process, the rapid scientific advice through the establishment of working groups and the adoption of regulatory flexibility measures for labelling and packaging can be highlighted. Currently (August 31, 2022), several medicines are authorized in the European Union to prevent and treat COVID-19. For instance, the six available vaccines (Comirnaty®, Nuvaxovid®, Jcovden®, Spikevax®, COVID-19 vaccine Valneva® and Vaxzevria®) and some drugs, such as remdesivir (Veklury®), sotrovimab (Xevudy®) and regdanvimab (Regkirona®), can be emphasized.
Description
Keywords
Autorização de introdução no mercado Medicamentos COVID-19 Regulamentação Agência europeia de medicamentos Administração de alimentos e medicamentos