Brazil Profile Updated

August 23, 2024
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The Brazil profile in ClinRegs has been reviewed and updated with the following information:

  • 2024 legislation on principles, guidelines, and rules for conducting research with human beings and establishing the National System of Ethics in Research with Human Beings (See Oversight of Ethics Committees and Timeline of Review)
  • National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) circular letters from 2023 and 2024 on exempt research, handling appeals, institutional strike/recess procedures, and consent from research participants under 18 and those lacking autonomy. (See Scope of Review, Timeline of Review, and Children/Minors)
  • National Data Protection Authority (Autoridade Nacional de Proteção de Dados (ANPD)) regulations, guidance, and related resources from 2023 and 2024 on personal data protection requirements for processing personal data, the use of databases, and consent (See Personal Data Protection)
  • National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) guidance and related resources from 2020, 2023, and 2024 on submitting electronic import license petitions via Solicita Electronic Petition Request System and Integrated Foreign Trade System (Siscomex) (See Regulatory Fees, Submission Process, Manufacturing & Import and Specimen Import & Export)
  • 2024 ANVISA regulation and related resources on collecting revenue from the from the Health Surveillance Inspection Fee (TFVS) (See Regulatory Fees and Submission Process)
  • 2023 regulation providing for research ethics committee (EC) (Comitê de Ética em Pesquisas (CEP)) registration, accreditation, renewal, alteration, suspension, and registration cancellation (See Ethics Committee and Oversight of Ethics Committees)
  • Regulations and resources from 2022 and 2024 on Equivalent Foreign Regulatory Authorities (Autoridades Reguladoras Estrangeiras Equivalentes (AREEs)) criteria and procedures (See Scope of Assessment and Quality Requirements)
  • Information on ANVISA’s Consultation System clinical trials search tool (See Initiation, Agreements & Registration)

Sources Added During this Update:

(Legislation) Law No. 8,069, of July 13, 1990 (LawNo8.069 - Portuguese) (Effective October 11, 1990)
Federative Republic of Brazil

(Legislation) Law No. 14,874, of May 28, 2024 (LawNo14.874 - Portuguese) (Effective August 27, 2024)
Federative Republic of Brazil

(Regulation) CD/ANPD Resolution No. 15, of April 24, 2024 (CD-ANPD-No15 - Portuguese) (Effective April 26, 2024)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Regulation) CD/ANPD Resolution No. 18, Of July 16, 2024 (CD-ANPD-No18 - Portuguese) (July 17, 2024)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Regulation) CNS Resolution No. 706 of February 16, 2023 (ResNo706 - Portuguese) (February 16, 2023)
National Health Council (CNS), Ministry of Health

(Regulation) CNS Resolution No. 738 of February 1, 2024 (ResNo738 - Portuguese) (February 1, 2024)
National Health Council (CNS), Ministry of Health

(Regulation) Ordinance No. 1,184, of October 17, 2023 (OrdNo1.184 - Portuguese) (Effective October 19, 2023)
Ministry of Health

(Regulation) Ordinance No. 344, of May 12, 1998  (OrdNo344 - Portuguese) (May 12, 1998)
Ministry of Health

(Regulation) Regulatory Instruction No. 289 of March 20, 2024 (RegNo289 - Portuguese) (Effective April 1, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Regulatory Instruction No. 292 of May 2, 2024 (RegNo292 - Portuguese) (Effective June 3, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 255, OF DECEMBER 10, 2018 (ResNo255 - Portuguese) (Effective December 11, 2018)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 658 of March 30, 2022 (ResNo658 - Portuguese) (Effective May 2, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board RDC No.741 of August 10, 2022 (ResNo741 - Portuguese) (Effective September 1, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board - RDC No. 811, of August 18, 2023 (ResNo811 - Portuguese) (September 1, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 836 of December 13, 2023 (ResNo836 - Portuguese) (Effective December 18, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board – RDC No. 857 of May 6, 2024 (ResNo857 - Portuguese) (Effective June 3, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Circular) Circular Letter No. 10/2024: Guidance on the Procedures to be Adopted in the Event of a Strike or Institutional Recess (CLNo10 - Portuguese) (English-CLNo10 - Google Translation) (April 9, 2024)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Circular) Circular Letter No. 11 – Guidelines Related to the Process of Obtaining Consent from Research Participants Under 18 Years of Age and People with a Permanent or Temporary “Lack of Autonomy” to Consent (CLNo11 - Portuguese) (English-CLNo11 – Google Translation) (July 26, 2023)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Circular) Circular Letter No. 29 – Guidelines for Forwarding Appeals to the CEP/CONEP System Instances (CLNo29 - Portuguese) (English-CLNo29 - Google Translation) (December 22, 2023)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Circular) Guidelines for the Implementation of Article 26 of CNS Resolution No. 674 of May 6, 2022, which Provides for the Classification of Research and the Processing of Research protocols in the CEP/CONEP System (CLNo12 - Portuguese) (English-CLNo12 - Google Translation) (July 27, 2023)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Guidance) Processing of Personal Data for Academic Purposes and for Carrying Out Studies and Research (G-PDP-Acad - Portuguese) (English-G-PDP-Acad - Google Translation) (June 2023)
National Data Protection Authority

(Notice) Statement of the CD/ANPD No.1 of May 22, 2023 (ANPD-No1 - Portuguese) (Effective May 24, 2023)
National Data Protection Authority (ANPD), Ministry of Justice and Public Security

(Article) ANPD Approves Data Breach Notifying Regulation (BRA-62) (May 6, 2024)
Manzueto, Cristiane; Leal, Rodrigo; Allavato, Ana Leticia; Semeraro, Diego; Tauil & Chequer Advogados

(Article) ANPD Approves the Security Incident Reporting Regulation (BRA-61 - Portuguese) (April 29, 2024)
KLA

(Article) ANPD Publishes Resolution on the Role of the Person Responsible for Processing Personal Data (BRA-116 - Portuguese) (July 17, 2024)
Mattos Filho

(Article) Anvisa Informs about Changes in Administrative Procedures for Imports (BRA-109 - Portuguese) (July 3, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) ANVISA’s Personal Data Protection Policy is Released (BRA-77 - Portuguese) (English-BRA-77 - Official Translation) (October 30, 2023)
Monteiro, Felipe De Arau̒jo and Mezher, Verginelli Giovanna; Kaznar Leonardos

(Article) ANVISA Updates Import Authorization Request Procedure with Mandatory Pre-Boarding (BRA-57 - Portuguese) (Last Updated October 11, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) ANVISA will Use Analysis from Equivalent Foreign Authorities for the GMP Inspection and Certification Process (BRA-64 - Portuguese) (Last Updated May 3, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) Brazilian National Health Surveillance Agency Approves Normative Ruling for Admitting Assessments by Foreign Authorities (BRA-26) (March 28, 2024)
CGM Advogados; Lexology

(Article) Do you Want to Know if a Clinical Trial is Authorized by ANVISA? (BRA-32 - Portuguese) (June 13, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Article) New Legal Framework for Clinical Trial with Human Subjects Approved in Brazil (BRA-117 - Portuguese) (June 3, 2024)
Mattos Filho

(Document) Research Participants’ Rights Booklet (BRA-29 - Portuguese) (English-BRA-29 - Google Translation) (Version 1.0) (2020)
National Research Ethics Commission (CONEP), National Health Council (CNS)

(Document) Solicita User Manual (BRA-47 - Portuguese) (English-BRA-47 - Google Translation) (Version 3.6) (Last Updated July 5, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(International Guidance) ICH Harmonised Guideline Addendum to ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population E11 (R1) (BRA-74) (Final Version) (August 18, 2017)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (BRA-66) (Step 4 Version) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Development Safety Update Report (E2F) (BRA-72) (Step 4 Version) (August 17, 2010)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (BRA-112) (Step 4 Version) (November 10, 2000)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) Addendum to ICH Guideline E6 to be Implemented within 2 Years (BRA‑113 - Portuguese) (Last Updated March 11, 2022)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) ANVISA Consultation System (BRA-44 - Portuguese) (Current as of August 23, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Business Registration (BRA-105 - Portuguese) (Current as of August 23, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Electronic Petition for Import (PEI) (BRA-108 - Portuguese) (Last Updated April 12, 2020)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) ICH Guideline Implementation (BRA-73) (Current as of August 23, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) ICH Members & Observers (BRA-65) (Current as of August 23, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) Import Authorization (BRA-110 - Portuguese) (Last Updated December 3, 2020)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Integrated Foreign Trade System (Siscomex) (BRA-106 - Portuguese) (Last Updated January 22, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Issue DARF for Payment of Federal Taxes (BRA-111 - Portuguese) (Last Updated March 21, 2024)
Federal Revenue Service, Government of Brazil

(Webpage) National Register of Legal Entities (CNPJ) (BRA-107 - Portuguese) (Current as of August 23, 2024)
Ministry of Finance

(Webpage) PagTesouro (BRA-114 - Portuguese) (Current as of August 23, 2024)
National Treasury

(Webpage) PagTesouro – Frequently Asked Questions (FAQs) (BRA-115 - Portuguese) (Last Updated January 19, 2021)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Webpage) Solicita Electronic Petition Request System Login (BRA-56 - Portuguese) (Current as of August 23, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

Sources Revised During this Update:

(Guidance) Manual: Petition for Import License through LPCO (G-LPCOImprtPetition - Portuguese) (Version 2.11) (Last Updated August 1, 2024)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Document) Annual Activity Report 2023 – Coordination of Clinical Research on Medicines and Biological Products – COPEC (BRA-60 - Portuguese) (English-BRA-60 – Google Translation) (7th Edition) (February 8, 2024)
Coordination of Clinical Research in Medicines and Biological Products (COPEC) Second Board of Directors, National Health Surveillance Agency (ANVISA)

(Document) Pharmaceutical Inspection Co-operation Scheme (PIC/S) Brochure (BRA-100) (September 2023)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

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