May 2018: Brazil Regulatory Update

In accordance with the LawNo9.782ResolutionNo9, and Ord650/2014, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is responsible for reviewing and approving clinical trial applications for registered and unregistered drugs. The scope of ANVISA’s assessment includes all clinical trials (Phases I-IV) for the following:

  • New therapeutic indication
  • New method of administration
  • New concentration
  • New pharmaceutical form
  • Expansion of use
  • New dosage
  • New associations
  • Any post-registration change requiring clinical data, including registration renewal

As stated in ResolutionNo9ResolutionNo466, and the PANDRH-GCPs, the institutional ethics committee (EC) (known as a Comitê de Ética em Pesquisas) (CEP)) must review and approve all clinical trial applications prior to ANVISA initiating its review and approval process. Applications with coordination or sponsorship originating outside of Brazil require an additional EC review by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP). Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval. Per ResolutionNo9, ANVISA’s approval of a clinical trial application is not dependent upon CONEP’s approval. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

Clinical Trial Review Process

As delineated in Ord650/2014, ANVISA’s Office of Clinical Research Coordination on Drugs and Biologicals (Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos (COPEC)) is responsible for conducting the review of clinical trial applications. ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). Per ResolutionNo9 and Additional Resource (A), upon receipt of the DDCM, ANVISA has 90 calendar days to evaluate the application. If ANVISA fails to issue a response in 90 days after receipt, clinical development can begin as long as all of the ethical approvals have been obtained.

As per OSNo001/2013, in the instance of a multicenter clinical trial, the principal investigator (PI) is required to submit a list of the participating institutions and the associated protocols as part of the research protocol package sent to the CEP for review.

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