Anvisa Publishes Implementation Plan for ICH E8(R1) and E6(R3) Guidelines
The Brazilian Health Regulatory Agency (Anvisa) has published its implementation plan for the ICH E8(R1) and ICH E6(R3) guidelines.
The plan is described in Technical Note No. 74/2026/SEI/COPEC/DIRE2/ANVISA and addresses the implementation of:
ICH E8(R1) — General Considerations for Clinical Studies;
ICH E6(R3) — Principles and Annex 1 on Good Clinical Practice (GCP). 1791040483782
A Gradual and Organised Implementation Approach
According to Anvisa, the proposed plan is intended to prepare stakeholders involved in clinical research for a gradual and organised implementation of the two ICH guidelines in Brazil.
The Agency plans to establish a working group to support implementation activities.
The group will be coordinated by Anvisa and supported by the Department of Science and Technology of the Ministry of Health (DECIT/MS).
Stakeholder Participation
The implementation process is expected to involve representatives from several parts of the clinical research ecosystem, including:
clinical trial centres;
clinical research professionals;
sponsors;
Representative Clinical Research Organisations;
associations and institutions representing these stakeholders.
This approach reflects Anvisa’s intention to involve regulated stakeholders directly in the transition to the updated ICH framework.
What Is ICH E8(R1)?
ICH E8(R1) sets out general considerations for the design and conduct of clinical studies.
The guideline is intended to support the development of studies that are scientifically sound, ethically appropriate and capable of generating reliable information.
Anvisa notes that the revised E8(R1) guideline was published by ICH on 6 October 2021.
What Is ICH E6(R3)?
ICH E6(R3) is the updated Good Clinical Practice framework.
The Principles and Annex 1 were published by ICH on 6 January 2025.
The revision modernises GCP expectations and is intended to support clinical trials that remain robust and reliable while accommodating evolving study designs, technologies and operational models.
Regulatory Harmonisation
Anvisa highlights that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to develop harmonised scientific and technical guidelines.
The objective is to increase consistency across countries in the requirements applied to the development and registration of medicines.
For clinical research, E8 and E6 are among the principal ICH guidelines used for planning and conducting clinical trials. 1791040483782
Previous Consultation With Stakeholders
The publication also refers to Anvisa’s earlier engagement with the clinical research community.
In May 2026, the Agency held the I Workshop on Good Clinical Practice Inspections, in partnership with the pharmaceutical industry.
The event was used to discuss and assess the potential impact of implementing ICH E8(R1) and E6(R3) in Brazil.
Anvisa states that the new implementation plan takes into account both the substantial changes introduced by the revised guidelines and the opinions collected during that event. 1791040483782
Why the Update Matters
The transition to ICH E8(R1) and E6(R3) may require organisations involved in clinical research to review existing processes, documentation and quality systems.
Potential areas requiring attention include:
clinical study design;
quality-by-design approaches;
risk-based quality management;
investigator and sponsor responsibilities;
clinical trial oversight;
data governance;
essential records;
informed consent processes;
vendor and service-provider oversight;
inspection readiness.
The exact operational changes will depend on how Anvisa implements the guidelines and on future supporting materials or regulatory instructions.
Impact on Sponsors and Clinical Research Organisations
For sponsors, CROs, clinical trial sites and regulatory teams operating in Brazil, the publication signals the start of a more structured transition toward the revised ICH standards.
Stakeholders should consider:
reviewing current SOPs against E8(R1) and E6(R3);
identifying gaps in quality systems;
assessing staff training needs;
evaluating sponsor and investigator responsibilities;
reviewing trial oversight arrangements;
monitoring Anvisa implementation timelines;
preparing for future GCP inspection expectations.
The gradual approach may provide organisations with time to adapt, but early preparation will be important given the breadth of changes introduced by the revised GCP framework.
Importance for Clinical Research in Brazil
The implementation of E8(R1) and E6(R3) represents an important step in aligning Brazilian clinical research requirements with updated international standards.
For multinational clinical development programmes, greater alignment with ICH principles may also help reduce differences between local and global study expectations.
Technical Note
The full implementation plan is available through Technical Note No. 74/2026/SEI/COPEC/DIRE2/ANVISA.
Anvisa also indicates that the document can be accessed through its portal under the clinical research and Good Clinical Practice guidance area. 1791040483782
