BRAZIL

Regulatory Authority: ANVISA

Overview of ANVISA

  • ANVISA is the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) in Brazil.

  • Responsible for clinical trial oversight, approval, and inspection of drugs to be registered in Brazil.

  • Operates under ResNo945, ResNo705 (amending ResNo585).

Legal Framework

  • Law No. 9.782 establishes ANVISA as an independent administrative agency linked to the Ministry of Health (MOH) for regulating, controlling, and supervising products and services involving public health risks.

  • Goods under ANVISA's regulation include:

    • Medicines for human use and active ingredients.

    • Immunobiologicals and their active substances.

    • Blood and blood products.

    • Advanced therapy products and their active components.

Organizational Structure

  • ANVISA is managed by a Collegiate Board responsible for strategic management and compliance with regulatory acts.

  • Organizational units operating under the Collegiate Board include:

    • General Management of Medicines (GGMED): Oversees the regulation of medicines and active pharmaceutical ingredients, quality assessments, and inspection coordination.

    • Coordination of Clinical Research on Medicines and Biological Products (COPEC): Oversees clinical research and Good Clinical Practice (GCP) inspections.

Recent Regulatory Updates

  • Decree No. 12,651 (effective October 8, 2025) regulates the 2024 clinical research law (Law No. 14.874).

  • RDC 997/2025: Established reliance review queue for petitions under ResNo945 and RegNo338.

  • RDC 1,001/2025: Outlines priority classification for registration, post-registration, and clinical trials.

Clinical Trial Review Process

  • Clinical trial applications (Dossiês de Desenvolvimento Clínico de Medicamento - DDCMs) must be submitted for approval.

  • Applications can be submitted at any stage of clinical development, except for Phase IV and non-interventional research.

  • Must obtain prior ethical approval from ECs (Comitês de Ética em Pesquisa).

  • DDCM and Specific Clinical Trial Dossiers (DEECs) are required for all proposed clinical trials.

Submission Requirements

  • Specific Clinical Trial Dossiers (DEEC) must be filed alongside the DDCM.

  • Submission of primary DDCM petitions must comply with G-DDCMManual guidelines and include:

    • GCP Declaration.

    • Investigator’s Brochure (IB).

    • Quality control documents.

Important Definitions and Concepts

  • Active Pharmaceutical Ingredients (APIs): Fundamental substances used for therapeutic effects in medications.

  • Good Clinical Practice (GCP): Ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

  • Substantial Modifications: Significant changes in trial protocols that impact quality or safety.

Ethical Considerations

  • Clinical trials involving human beings require prior ethical analysis by ECs in compliance with Law No. 14.874 and associated resolutions.

  • Rights of participants must be safeguarded, including informed consent and the right to withdraw at any time.

Informed Consent Requirements

  • Informed Consent Form (ICF) (Termo de Consentimento Livre e Esclarecido) must be obtained from participants, detailing:

    • Study purpose, duration, risks, benefits, and participant responsibilities.

    • Assurances of confidentiality and maintenance of participant rights.

Vulnerable Populations

  • Special protections must be in place for vulnerable populations, including:

    • Individuals with reduced capacity for decision-making.

    • Specific provisions for children, the elderly, prisoners, and those with mental impairments.

Data Protection and Confidentiality

  • General Law on the Protection of Personal Data (LGPD) requires that personal data processed during clinical trials is managed responsibly, ensuring confidentiality and participant rights.

  • Consent for data processing must be explicit and can be revoked at any time.

Document Submission Requirements

  • All clinical trial documentation must be submitted electronically via ANVISA’s system (Solicita System).

  • Documentation includes:

    • Original clinical trial applications.

    • Safety and quality assurance documents.

    • Investigator’s Brochure and modified trial protocols.

Monitoring and Inspection

  • ANVISA is authorized to conduct inspections of clinical research centers and monitor compliance with GCP standards.

  • Inspections focus on ensuring the rights of participants and adherence to trial protocols.

Cancellation and Suspension of Trials

  • ANVISA can suspend or cancel a trial based on:

    • Violation of study requirements or participant safety.

    • Unsafe conditions for trial participants as indicated by adverse event reporting.

Import and Export Regulations

  • Importing investigational products requires permit approval through ANVISA, with stringent record-keeping and compliance requirements.

  • Policies on the shipment of biological materials ensure adherence to national and international regulations.


Submission Requirements

  • Specific Clinical Trial Dossiers (DEEC) must be filed alongside the DDCM.

  • Submission of primary DDCM petitions must comply with G-DDCMManual guidelines and include:

    • GCP Declaration.

    • Investigator’s Brochure (IB).

    • Quality control documents.