Brazil's Clinical Trial Regulations

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is the regulatory authority responsible for review and approval of clinical trial applications for registered and unregistered drugs. ANVISA is attached to the Ministry of Health (MOH), which grants it authority to regulate food and drug laws in Brazil.

A Clinical Trial Application is referred to as the Drug Clinical Development Dossier or Desenvolvimento Clínico de Medicamento (DDCM) and ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin

Document Number Document Title Issued by Description Available Languages Download
RDC No. 9/2015 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 9, OF FEBRUARY 20th, 2015 Anvisa Provides for the Regulation for conducting clinical trials with medicines in Brazil. English/Portuguese For Sale
RDC No. 10/2015 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 10, OF FEBRUARY 20th, 2015 Anvisa Regulations for clinical trials with medical devices in Brazil. English/Portuguese For Sale
RDC No. 205/2017 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 205, OF DECEMBER 28th, 2017 Anvisa Establishes a special procedure for the consent of clinical trials, certification for good manufacturing practices and registration of new drugs for treatment, diagnosis or prevention of rare diseases. English/Portuguese For Sale
RDC No. 204/2017 RESOLUTION OF THE COLLEGIATE BOARD - RDC No. 204, OF DECEMBER 27th, 2017 Anvisa Features on the framework in the priority category, petitions of registration, post- registration and prior consent in clinical research of drugs. English/Portuguese For Sale
IN No. 20/2017 NORMATIVE INSTRUCTION - IN No. 20, OF OCTOBER 2nd, 2017 Anvisa Provides for the inspection procedures in Good Clinical Practices for clinical trials with medications. English/Portuguese For Sale
Technical Note No. 004/2016 TECHNICAL NOTE No. 004/2016/GGTPS/DIREG/ANVISA Anvisa Requirements to determine the need for clinical trials and guidelines for submission of data on safety and effectiveness for the purposes of registration of health products at the General Management of Technology of Health Products. English/Portuguese For Sale
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