Brazil Profile Updated

April 12, 2023
Subscribe to these updates

The Brazil profile in ClinRegs has been reviewed and updated with the following information:

  • National Health Council (Conselho Nacional de Saúde (CNS)) regulation from 2022 providing review criteria and timelines to classify research and process protocols in the institutional ethics committee (EC) (Comitê de Ética em Pesquisas (CEP))/National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) system (See Scope of Review, Oversight of Ethics Committees, and Timeline of Review)
  • Additional sources from 2022 providing clarification on CNS regulation establishing the protocol classification and processing system in the CEP/CONEP System (See Scope of Review)
  • Various CONEP circular letters issued between 2011 and 2022 related to protocol review and processing procedures, submission instructions, investigator responsibilities, and more (See Scope of Review for complete list)
  • National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) resolution from 2022 on submitting Specific Clinical Trial Dossiers (Dossiês Específico de Ensaio Clínico (DEECs)) for comparative bioavailability studies and comparative biosimilar pharmacokinetic studies (See Submission Process)
  • ANVISA resolution from 2022 regarding the simplified analysis of COVID-19 related Clinical Drug Development Dossiers (DDCMs), amended DDCMs, and substantially amended protocols (See Scope of Assessment and Timeline of Review)
  • AVISA technical note from 2022 providing clarification on regulations related to: the suspended pre-submission meeting requirement for rare disease DDCM petitions; the simplified analysis of COVID-19 related DDCM petitions; and the amended review deadline for clinical research DDCM petitions (See Scope of Assessment)
  • ANVISA resolution from 2021 on submitting COVID-19 vaccine DDCM petitions by Brazilian public universities or publicly funded institutions (See Scope of Assessment and Timeline of Review)
  • ANVISA notice from 2022 on submitting email notifications of unexpected serious adverse events (SAEs) (See Safety Reporting)

Sources Added During this Update:

(Circular) Circular Letter No.008/2011 - Form to Submit Serious Adverse Events (SAEs) to CONEP (CLNo008 - Portuguese) (June 22, 2011)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Circular) Circular Letter No. 062/2011 - Documents Required for Center Inclusion; Center Exclusion; Change of Coordinating Center and Investigator; Transfer of Study Site; Change of Investigator; Cancellation; Suspension and Closure of the Study (CLNo062 - Portuguese) (July 19, 2011)
National Health Council (CNS), Ministry of Health

(Circular) Circular Letter No. 23/2022 -– Standardization of the Use of Consent and Electronic Assent for Research Participants and Biobanks (CLNo23 – Portuguese) (October 17, 2022)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 24/2022 – General Guidelines for Conducting Clinical Trials (CLNo24 – Portuguese) (October 17, 2022)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 34/2021 – New Guidelines for Processing Biobank Development Research Protocols through the Current Version of Plataforma Brasil (CLNo34 – Portuguese) (December 9, 2021)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 26/2022 – Guidelines for Studies with Human Bodies or Anatomical Parts (CLNo26 – Portuguese) (December 1, 2022)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 25/2022 – Conducting CEP/CONEP System Meetings in a Virtual Environment (CLNo25 – Portuguese) (October 17, 2022)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 39/2011 - Use of Medical Records Data for Research Purposes (CLNo039 - Portuguese) (September 30, 2011)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Circular) Clarification Note on Circular Letter No. 24/2022 – General Guidelines for Conducting Clinical Trials (CLNo24-Note – Portuguese) (October 26, 2022)
National Research Ethics Commission (CONEP), Executive Secretariat of the National Health Council (CNS)

(Circular) Circular Letter No. 183/2017 – Linking the Investigator and Institutions to the CEP (CLNo183 – Portuguese) (May 8, 2017)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Regulation) Resolution of the Collegiate Board - RDC No. 534 of August 23, 2021 (ResNo534 - Portuguese) (Effective August 25, 2021)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 601 of February 9, 2022 (ResNo601 - Portuguese) (Effective February 16, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) CNS Resolution No. 674, of May 6, 2022 (ResNo674 - Portuguese) (May 6, 2022)
National Health Council (CNS), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 742 of August 10, 2022 (ResNo742 - Portuguese) (Effective July 3, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) ANVISA Advises on Notification of Serious Adverse Events (BRA-78 - Portuguese) (Last Updated November 1, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) Draft Bill on Human Clinical Trials in Brazil (BRA-5) (June 7, 2022)
Maier, Camilla Mikaelian and Jambor, Daniela Guarita; SP Law

(Document) Research Ethics: Note on CNS Resolution No. 674/2022 - CEP/CONEP System (BRA-4 - Portuguese) (May 21, 2022)
National Association of Graduate Studies and Research in Education (Anped)

(Document) Technical Note No. 13/2022: Guidance on the Application of the Criteria Established by Resolution No. 763, Resolution No. 601, and Resolution No. 573 (BRA-3 - Portuguese) (December 12, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Not Available Online) NIAID Communication with Fiocruz (February 2023) (BRA-9)

(Webpage) Coordination of Clinical Research in Medicines and Biological Products (COPEC) (BRA-18 - Portuguese) (Last Updated November 21, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) General Management of Medicines (GGMED) (BRA-12 - Portuguese) (Last Updated July 29, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

Sources Revised During this Update:

(Guidance) Primer: Import License Petition through LPCO (G-LPCOImprtPetition - Portuguese) (Version 4.8) (March 22, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) ANVISA is Approved for Pharmaceutical Inspection Cooperation Scheme - PIC/S (BRA-55 - Portuguese) (Last Updated November 3, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Document) Pharmaceutical Inspection Co-operation Scheme (PIC/S) Brochure (BRA-100) (September 2022)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

(Webpage) Obtain Authorization to Import Drug Substance (BRA-103 - Portuguese) (Last Updated January 5, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Request Product Import Licensing Subject to Sanitary Surveillance through LPCO (BRA-104 - Portuguese) (Last Updated January 5, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Electronic Petition - Request System (BRA-38 - Portuguese) (Last Updated January 12, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

Back to list