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. 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 Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 10/2015: Regulations for Clinical Trials with Medical Devices in Brazil | This Resolution aims to define the procedures and requirements for conducting clinical trials with medical devices in Brazil. | Anvisa | English | For Sale |
| RDC No. 9/2015: Regulations for Clinical Trials with Medicines in Brazil | This Resolution aims to define the procedures and requirements for conducting clinical trials with medicines, including the submission of the Drug Clinical Development Dossier (DDCM) to be approved by Anvisa. | Anvisa | English | For Sale |
| IN No. 20/2017: Good Clinical Practices Inspection Procedures for Drug Clinical Trials | Normative No.20 aims to establish inspection procedures to harmonize, guide and verify the compliance with the Good Clinical Practices (GCP) in clinical trials with drugs. | Anvisa | English | For Sale |
| RDC No. 204/2017: Framework for Priority in the Registration, Post-Registration and Prior Consent in Drug Clinical Research | The Resolution outlines the criteria and procedures for the priority registration, post-registration and prior consent in clinical research of drugs. | Anvisa | English | For Sale |
| RDC No. 205/2017: Special Procedure for the consent of Clinical Trials, Good Manufacturing Practices Certification and New Drug Registration for the treatment, diagnosis or prevention of Rare Diseases | The Resolution provide the special procedure for the consent of clinical trials to be conducted in Brazil for the evaluation of drugs for rare diseases; the certification for good manufacturing practices (GMP) applicable to drugs for rare diseases; and the health registration of new drugs for rare diseases. | Anvisa | English | For Sale |
| TECHNICAL NOTE No. 004/2016: Technical note about the need for submission of clinical trials for the purposes of registration of health equipment and materials. | 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. | Anvisa | English | For Sale |