ANVISA Publishes 2024–2025 Good Clinical Practice Inspection Metrics: What Clinical Trial Sponsors and Manufacturers Should Know
Brazil’s health authority, ANVISA, has published its new Good Clinical Practice (GCP) Inspection Metrics Report 2024–2025, providing valuable insight into the most frequent inspection findings observed during clinical trial inspections across the country.
The report covers inspections performed in clinical trial centres during 2024 and 2025 and highlights recurring critical and major deficiencies affecting data integrity, participant safety, electronic systems, quality management, and investigational product control.
For manufacturers and sponsors conducting or planning clinical investigations in Brazil, the publication offers a clear indication of ANVISA’s current inspection priorities and enforcement expectations.
Key Inspection Data
According to the report:
12 GCP inspections were conducted in 2024–2025;
11 were routine inspections and 1 was investigative;
Inspections covered both public and private clinical trial centres across several Brazilian states;
Most inspected studies were Phase III clinical trials.
ANVISA reported a total of 136 inspection findings across 11 completed inspection reports, classified as:
31 critical findings
62 major findings
37 minor findings
6 informational observations
The authority noted that although the total number of findings decreased compared to 2023, this was partly due to changes in how findings are categorised and counted.
Main Areas of Non-Compliance
The report identifies several recurring inspection deficiencies that are particularly relevant for sponsors, CROs, and manufacturers overseeing clinical investigations.
1. Source Documentation and CRF Data Integrity
One of the most significant areas of concern involved inconsistencies between:
source documents,
electronic medical records,
and Case Report Forms (CRFs).
ANVISA identified critical findings related to:
delayed or retrospective data entry,
discrepancies between source data and CRFs,
incomplete participant records,
missing documentation supporting protocol-required procedures,
inadequate traceability of electronic data changes,
and data entered directly into sponsor systems without site access.
Why this matters for manufacturers
Manufacturers sponsoring clinical investigations should reassess:
electronic data governance,
monitoring oversight,
audit trail configuration,
source data verification processes,
and site training on contemporaneous documentation practices.
The report also reinforces ANVISA’s increasing focus on ALCOA+ data integrity principles and electronic record traceability.
2. Electronic Systems Validation
ANVISA highlighted several major and critical findings involving electronic systems used in clinical studies, including:
eCRF platforms,
ePRO systems,
IRT systems,
and Trial Master Files (TMFs).
Observed deficiencies included:
absence of system validation,
lack of study-specific validation,
inadequate user access controls,
insufficient audit trail management,
and continued access for personnel who had already left the study.
Impact for sponsors and CROs
Manufacturers using global electronic platforms in Brazil should verify whether:
validation documentation is readily available during inspection,
local study configurations have been assessed,
access management procedures are robust,
and electronic systems comply with ICH E6(R2) expectations.
This becomes particularly important as ANVISA references the ongoing implementation of ICH E6(R3) principles in Brazil.
3. Quality Systems and SOP Governance
The report also identified significant weaknesses in quality systems and SOP management, including:
missing SOP references,
inconsistent version control,
inadequate training documentation,
and ineffective quality management systems.
ANVISA specifically stressed the importance of:
documented procedures,
training traceability,
version history,
and controlled document management systems.
What manufacturers should review
Manufacturers and sponsors should evaluate whether:
SOP governance structures are inspection-ready,
training records are complete and contemporaneous,
delegated activities are clearly documented,
and quality oversight extends effectively to CROs and investigational sites.
4. Investigational Product Management
Inspection findings also covered investigational product management, including:
inadequate temperature monitoring,
insufficient restricted access controls,
incomplete accountability records,
and lack of contingency procedures during weekends or holidays.
ANVISA additionally identified issues involving:
investigational product reconciliation,
missing kit traceability,
and inconsistencies in stock control documentation.
Manufacturer implications
Sponsors should ensure that:
IMP accountability procedures are fully traceable,
pharmacy oversight is clearly defined,
monitoring activities adequately verify storage conditions,
and contingency processes are documented and operational.
Increased Regulatory Maturity in Brazil
The report also reflects the continued strengthening of Brazil’s clinical trial regulatory framework.
ANVISA references:
Law 14.874/2024, which formally establishes the authority to conduct GCP inspections and links non-compliance to sanitary penalties;
RDC 945/2024, which updated Brazil’s clinical trial framework;
and the evolving implementation of ICH E6(R3) principles.
This indicates a progressively more mature and risk-based inspection environment, aligned with international expectations.
Final Thoughts
ANVISA’s 2024–2025 inspection metrics report provides a useful benchmark for manufacturers, sponsors, and CROs operating clinical trials in Brazil.
The findings clearly demonstrate that regulators are increasingly focused on:
data integrity,
electronic systems governance,
quality management systems,
sponsor oversight,
and investigational product traceability.
Companies preparing for inspections in Brazil should use these findings proactively to strengthen internal controls, site oversight, and GCP compliance programmes.
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