Brazil Profile Updated
December 8, 2021
The Brazil profile in ClinRegs has been updated with the following information:
- RDC No. 573 of October 29, 2021, which changes, on an emergency and temporary basis, RDC No. 9 of February 20, 2015, which approves the regulation for conducting clinical trials with medicines in Brazil (See Scope of Assessment, Scope of Review, and Submission Process)
- New guidelines on scheduling a pre-submission hearing or a hearing to discuss a previously submitted clinical trial application (See Scope of Assessment, Submission Process, Timeline of Review, and Trial Authorization)
- Requirements related to processing new versions of the Investigator's Brochure via Plataforma Brasil (See Scope of Assessment and Scope of Review)
- Updated safety reporting instructions, including details on registering sponsors and submitting serious adverse event notifications via VigiMed (See Safety Reporting)
- Resolution requiring all ethics committees (Comitês de Ética em Pesquisas (CEPs)) in Brazil to appoint research participant representatives (See Ethics Committee)
- Updated manual on submitting Clinical Drug Development Dossier (DDCM) modifications, amendments, suspensions, and cancellations (See Submission Process, Submission Content, Safety Reporting, and Trial Authorization)
- New resolution related to clinical trials with advanced research therapy products in Brazil (See Scope of Assessment and Scope of Review)
- New resolutions related to the transport of biological material of human origin and good practices in human cells for therapeutic use and clinical research (See the Specimens topic)
Sources Added During this Update:
- (Regulation) CNS Resolution No. 647 of October 12, 2020 (ResNo647 - Portuguese) (October 12, 2020)
National Health Council, Ministry of Health - (Regulation) Ordinance No. 188 of February 3, 2020 (OrdNo188 - Portuguese) (GoogleTranslate-OrdNo188) (February 3, 2020)
Ministry of Health - (Regulation) Resolution of the Collegiate Board - RDC No. 506 of May 27, 2021 (ResNo506 - Portuguese) (Effective July 1, 2021)
ANVISA, Ministry of Health - (Regulation) Resolution of the Collegiate Board - RDC No. 508 of May 27, 2021 (ResNo508 - Portuguese) (Effective July 1, 2021)
ANVISA, Ministry of Health - (Regulation) Resolution of the Collegiate Board - RDC No. 504 of May 27, 2021 (ResNo504 - Portuguese) (Effective July 1, 2021)
ANVISA, Ministry of Health - (Regulation) Resolution of the Collegiate Board - RDC No. 573 of October 29, 2021 (ResNo573 - Portuguese) (Effective October 29, 2021)
ANVISA, Ministry of Health - (Circular) Circular Letter No. 040 - Processing of the Investigator's Brochure via Plataforma Brasil (PB) (CLNo040 - Portuguese) (March 27, 2015)
National Research Ethics Commission, National Health Council, Ministry of Health - (Article) Clinical Research: Guidelines on Scheduling a Hearing (BRA-89 - Portuguese) (May 24, 2021)
ANVISA, Ministry of Health - (Article) Measure Expands the Authorization of Clinical Trials with Drugs in Brazil (BRA-92 - Portuguese) (Last Updated November 4, 2021)
ANVISA, Ministry of Health - (Article) Published Manual on Submission of Clinical Trial Modifications (BRA-82 - Portuguese) (April 28, 2021)
ANVISA, Ministry of Health - (Document) ANVISA Serious Adverse Event Notification Spreadsheet (BRA-84 - Portuguese) (Date Unavailable)
ANVISA, Ministry of Health - (Document) Plataforma Brasil - Researcher User Manual (BRA-91- Portuguese) (Version 3.2) (Last Updated December 10, 2018)
National Health Council, Ministry of Health - (Document) Technical Note 12/2021 - Guidance for Scheduling Hearings with the Coordination of Clinical Research in Medicines and Biological Products (COPEC) (BRA-90 - Portuguese) (May 21, 2021)
ANVISA, Ministry of Health - (Document) VigiMed: Adverse Event Reporting System in Drug Use - Questions and Answers (BRA-85 - Portuguese) (Version 1.0) (July 2019)
ANVISA, Ministry of Health - (International Guidance) ICH Guideline E2B (R3) on Electronic Transmission of Individual Case Safety Reports (ICSRs) - Data Elements and Message Specification - Implementation Guide (BRA-88) (Step 5 Version) (July 2013)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - (Webpage) VigiMed (BRA-83 - Portuguese) (Current as of December 7, 2021)
ANVISA, Ministry of Health
Sources Revised During this Update:
- (Guidance) Manual for Submission of Modifications, Amendments, Suspensions and Cancellations (G-DDCMAmdmts - Portuguese) (5th Edition) (April 26, 2021)
General Management of Medicines (GGMED), Coordination of Clinical Research in Medicines and Biological Products (COPEC), ANVISA - (Article) ANVISA Advises on Notification of Serious Adverse Events (BRA-78 - Portuguese) (Last Updated March 26, 2021)
ANVISA, Ministry of Health - (Document) Annex of Manual for Submission of Clinical Drug Development Dossier (DDCM) and Specific Clinical Trial Dossier (BRA-13 - Portuguese) (5th Edition) (Date Unavailable)
ANVISA, Ministry of Health - (Webpage) ANVISA - Notification of Adverse Events in Clinical Trials (BRA-37 - Portuguese) (Last Updated on May 28, 2021)
ANVISA, Ministry of Health