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ANVISA abre consulta pública para reavaliar o prazo de aprovação de estudos clínicos originados no exterior.

 Central Rádio Jornalismo - parte 1 08/05/12

 Central Rádio Jornalismo - parte 2 08/05/12

The proposal, which is on public consultation, should be published today
FROM BRASÍLIA

Anvisa (National Health Surveillance Agency) promises to simplify and make the approval to carry out clinical researches aimed at the development of drugs and health products faster.The clinical research is one of the last steps before the registration of new products and involves tests with patients.

The idea is that researches which have already been approved by recognized agencies abroad – such as the American (FDA), the Australian and the Japanese – may go through a simplified analysis procedure by Anvisa.

And this proposal was approved by the Collegiate Board of the Agency on the day before yesterday and should be published today in the form of a public consultation, open for the next 30 days.

INTERNATIONAL

The direct impact will be greater in researches originated in a foreign country and with arms in many others, one of which Brazil, according to Dirceu Barbano, CEO of the Health Surveillance Agency.
"Our standard was to analyze the whole study [carried out abroad] again. It takes time; it sometimes meant that Brazil would be excluded from the study. We came to the conclusion that a simplified analysis is possible, evaluating specific health risk issues in the country,” he says.

Issues such as which centers will be used and if they have the capacity to develop the study will be evaluated by Anvisa, but the study design  (such as the statistical calculation to ensure the effectiveness of the analysis), will not.

DELAY

According to Barbano, the wait for the authorization of such researches has already been three months, but due to the increase in demand for national research centers, the delay may be up to seven months today. The goal is that this time drops to 30 days.

As a result, the agency would still have more agility in the approval of fully national researches, which need to go through a comprehensive analysis of Anvisa.

Greyce Lousana, Executive President of SSPPC (Brazilian Society of Clinical Research Professionals), says that the reduction in the time limits could open the way for patients with serious or rare diseases to have access to experimental drugs.She says that, recently, a research on breast cancer did not come to Brazil due to lengthy time limits – from Anvisa and the Ethics Committee of the institution - and therefore failed to benefit about one hundred patients.

Lousana, however, supports further changes to the regulation in force, such as totally separate analyses between drugs and other health products, which can shorten the time limits for analysis. (JN)

Entrevista com Charles Schmidt, fundador e vice-presidente da Associação Brasileira de Organizações Representativas de Pesquisas Clínicas.

Fonte: CBN - A Rádio que toca notícia

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 Rádio CBN - 07/04/12

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 CBN Saúde - Pesquisas Clínicas - 19/01/12

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 Programa Gente que fala - 30/11/11

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Resumo 

A Anvisa está em consulta pública para regulamentar o acesso a remédios que ainda estão em estudo, o que beneficia pacientes participantes de pesquisas clínicas. A discussão é antiga e hoje não há uma regra clara que estabeleça a continuidade do tratamento após o término da análise. A Anvisa quer o estabelecimento de critérios claros e objetivos para o acesso, já que o acesso indiscriminado pode trazer riscos aos pacientes. Sobre o assunto, o integrante da diretoria da Associação Brasileira de Organizações Representativas de Pesquisas Clínicas, Fernando Francisco, conversou com os jornalistas Lincon Macário e Daniele Popov.

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 Rádio São Francisco - 31/10/11

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 Rádio Globo - 17/10/11