RESOLUÇÃO RDC Nº 634, DE 24 DE Março DE 2022
Data de publicação | 30 Março 2022 |
Data | 24 Março 2022 |
Páginas | 299-299 |
Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Diretoria Colegiada |
Seção | DO1 |
RESOLUÇÃO RDC Nº 634, DE 24 DE Março DE 2022
Institui o Sistema de Informações de Estudos de Equivalência Farmacêutica e Bioequivalência (SINEB) e o Cadastro Nacional de Voluntários em Estudos de Bioequivalência (CNVB).
A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das atribuições que lhe confere o art. 7º, inciso III, aliado ao art. 15, III e IV, da Lei nº 9.782, de 26 de janeiro de 1999, e ao art. 187, VI, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 585, de 10 de dezembro de 2021, resolve adotar a seguinte Resolução, conforme deliberado em reunião realizada em 23 de março de 2022, e eu, Diretor-Presidente, determino a sua publicação.
Art. 1º Fica instituído o Sistema de Informações de Estudos de Equivalência Farmacêutica e Bioequivalência (SINEB) e o Cadastro Nacional de Voluntários em Estudos de Bioequivalência (CNVB).
Parágrafo único. O CNVB é parte integrante do SINEB.
Art. 2º Para efeito desta Resolução, ficam estabelecidas as seguintes definições:
I - sujeito de pesquisa: é o(a) participante pesquisado(a), individual ou coletivamente, de caráter voluntário, vedado qualquer forma de remuneração. O termo "voluntário" é usado como sinônimo de "sujeito de pesquisa";
II - Sistema de Informações em Estudos de Equivalência Farmacêutica e Bioequivalência (SINEB): é um sistema com a finalidade de controlar e monitorar as atividades dos centros de Equivalência Farmacêutica e de Biodisponibilidade/Bioequivalência que realizam estudos para o registro de medicamentos no...
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