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Quadro de intervenção das Nações Unidas na harmonização regulamentar: o caso do medicamento
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O desenvolvimento de normas, guidelines, padrões éticos e científicos que promovam a garantia de qualidade, segurança e eficácia dos medicamentos é uma das principais responsabilidades da Organização Mundial de Saúde. Estes documentos são emitidos através dos relatórios dos departamentos e comités desta organização, sob a forma de Tecnhical Report Series, e incluem guidelines sobre a pré-qualificação dos medicamentos, sobre os procedimentos de obtenção da Autorização de Introdução no Mercado, sobre o Controlo de Qualidade dos laboratórios, sobre Ensaios clínicos, Boas Práticas de Distribuição (Good Distribution Practices - GDP) e, ainda, sobre Boas Práticas de Fabrico (Good Manufacturing Practices – GMP). Mesmo que os requisitos implementados nas diversas regiões globais não sejam comuns e provenham de edições diferentes das GMP, a partilha de informações entre os Estados-membros, através da Organização Mundial de Saúde, acaba por facilitar a circulação dos medicamentos e, consequentemente, o acesso à inovação.
A Organização Mundial de Saúde tem ainda um papel de observador em iniciativas externas de uniformização da área regulamentar, como a Convenção Internacional de Harmonização (ICH), tendo influência nas alterações regionais realizadas em algumas das normas que daí originam. No entanto, são vários os países que, ainda que pertencentes a determinadas regiões, não fazem parte dessas iniciativas de harmonização, pelo que compete à Organização Mundial de Saúde recolher e analisar dados, de modo a obter informação sobre quais as principais lacunas nos seus sistemas regulamentares. A Global Benchmarking Tool é a ferramenta utilizada pela Organização Mundial de Saúde para realizar essa avaliação.
Ao nível da Saúde Pública, a Organização Mundial de Saúde tem-se focado no controlo das resistências antimicrobianas, no combate a doenças infeciosas e na publicação de uma lista com os principais medicamentos necessários para satisfazer as necessidades de grande parte da população. Atualmente, o seu principal foco de atuação é a resposta à pandemia de COVID-19. A coordenação a nível regulamentar permite cimentar os processos de pré-qualificação, distribuição e produção dos medicamentos, o que por sua vez permite ajudar a combater a contrafação e a circulação de medicamentos abaixo dos padrões de qualidade exigidos, que representam uma ameaça para a Saúde Pública.
The development of recommendations, guidelines, ethic and scientific standards that promote the assurance of quality, safety and efficacy of medicines worldwide is one of the main responsibilities of the World Health Organization. These documents are published through the reports from the World Health Organization’s committees and programmes, as Technical Report Series, and include guidelines about medicines and pharmaceutical products prequalification, procedures to accelerate marketing authorization, laboratory and research institutes quality control, standards and norms for clinical trials, Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). Even though these requirements may not be exactly the same in specific regions, and different editions of GMP being implemented amongst them, sharing information between the Member States, through the World Health Organization, facilitates medicines circulation and, on consequence, access to health care innovation. Aside from its own committees, the World Health Organization has an observer position in some regulatory harmonization initiatives, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, having influence on some changes that are made to the subsequent recommendations. However, there are many countries which, although being a part of a specific region, do not belong to its regulamentar uniformization initiative. In these cases, World Health Organization has a main role in collecting and analyzing data, to obtain information about the difficulties and problems of these countries regulatory systems. The Global Benchmarking Tool has been used to pursue these evaluation. Within a Public Health perspective, the World Health Organization has been focusing on controlling antibiotics resistance, fighting falsified and substandard pharmaceutical products and publishing a list with the essential drugs to satisfy the need of the majority of the population. Nowadays, it has also been focusing on giving response to the COVID-19 pandemic. Regulatory cooperation provides the opportunity to solidify the processes of prequalification, distribution and production of medicines. This leads to help the fight against falsified and substandard drugs, which are a threat to Public Health.
The development of recommendations, guidelines, ethic and scientific standards that promote the assurance of quality, safety and efficacy of medicines worldwide is one of the main responsibilities of the World Health Organization. These documents are published through the reports from the World Health Organization’s committees and programmes, as Technical Report Series, and include guidelines about medicines and pharmaceutical products prequalification, procedures to accelerate marketing authorization, laboratory and research institutes quality control, standards and norms for clinical trials, Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). Even though these requirements may not be exactly the same in specific regions, and different editions of GMP being implemented amongst them, sharing information between the Member States, through the World Health Organization, facilitates medicines circulation and, on consequence, access to health care innovation. Aside from its own committees, the World Health Organization has an observer position in some regulatory harmonization initiatives, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, having influence on some changes that are made to the subsequent recommendations. However, there are many countries which, although being a part of a specific region, do not belong to its regulamentar uniformization initiative. In these cases, World Health Organization has a main role in collecting and analyzing data, to obtain information about the difficulties and problems of these countries regulatory systems. The Global Benchmarking Tool has been used to pursue these evaluation. Within a Public Health perspective, the World Health Organization has been focusing on controlling antibiotics resistance, fighting falsified and substandard pharmaceutical products and publishing a list with the essential drugs to satisfy the need of the majority of the population. Nowadays, it has also been focusing on giving response to the COVID-19 pandemic. Regulatory cooperation provides the opportunity to solidify the processes of prequalification, distribution and production of medicines. This leads to help the fight against falsified and substandard drugs, which are a threat to Public Health.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2020, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Harmonização Qualificação Guidelines Padrões Autoridades Mestrado integrado - 2020