Brazil- Anvisa

Overview:

Brazil’s Anvisa adopts new workflow to accelerate requests for clinical studies with drugs for prevention and treatment of Covid-19.

COVID-19 Clinical Trial Committee

Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19. The committee is responsible for analyzing requests for approval of clinical studies with drugs for prevention and treatment of Covid-19, on a priority basis, within an average period of 72 hours after the formal submission of the protocol, among other duties.

Due to the increase in the number of Drugs Clinical Development Dossiers (DDCMs) and Clinical Trial Specific Dossiers (DEECs), Anvisa has adopted a new flow for the evaluation of requests for clinical trials

STEP 1 

The interested company should send an e-mail the COVID-19 Committee with the following information: 

  •  Text: summarized data of the research, petition schedule and expected start of studies in Brazil.
  •  Attachments: complete documentation of the DDCM and at least one DEEC, according to RDC 09/2015

STEP 2

The Committee evaluates the documentation and forwards by e-mail the main questions regarding the DDCM and the DEEC.

STEP 3

The company submits the DDCM/DEEC officially by Datavisa, with the answers to the questions sent by e-mail.

STEP 4

If the issues are resolved, the DDCM/DEEC is authorized. The Committee may schedule a meeting with the company to clarify the outstanding issues and the study may be authorized upon commitment by the company to submit the missing documentation (if applicable).

Regulatory Corner:

It is important to clarify that if the company formally files the DDCM/DEEC without having previously submitted the complete documentation, it may not be possible for the Committee to manifest its position within an average period of 72 hours.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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