mtruong wrote: It's possible the trial approval is
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Posted On: 06/16/2021 2:28:06 AM
mtruong wrote:
I wasn't sure this made sense -- isn't the idea of a clinical trial to determine if a drug is ethical? -- but you are quite right, mt.
This is from https://www.clinicaltrialsarena.com/news/rd-o...4935576-2/
So, great. More hoops to jump through.
Quote:
It's possible the trial approval is a multi-step process. One step is approval by an Etchics committee and then it goes to ANVISA for protocol approval.
I wasn't sure this made sense -- isn't the idea of a clinical trial to determine if a drug is ethical? -- but you are quite right, mt.
This is from https://www.clinicaltrialsarena.com/news/rd-o...4935576-2/
Quote:
The regulatory process to approve clinical trials in the country requires approval by two entities, an ethical approval by CONEP (Comissão Nacional de Éticaem Pesquisa/National Ethics Commission) and a regulatory approval by ANVISA (Agência Nacional de Vigilância Sanitária/National Agency of Health Surveillance)
So, great. More hoops to jump through.
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