ANVISA Risk-Based Inspection: What You Need to Know About Brazil's New Compliance System
Learn about Brazil's new compliance system, ANVISA's Risk-Based Inspection, and its impact on pharmaceutical safety and market access.
Quick Answer
Learn about Brazil's new compliance system, ANVISA's Risk-Based Inspection, and its impact on pharmaceutical safety and market access.
Key Questions
- What is ANVISA RDC 982/2025?
- Which companies must comply with RDC 982/2025?
- How does the ANVISA risk-based inspection system work?
- What is an Equivalent Foreign Regulatory Authority (AREE)?
- When does RDC 982/2025 take effect?
ANVISA's RDC 982/2025 introduces a risk-based inspection system that transforms how Brazil certifies Good Manufacturing Practices (CBPF) and Good Distribution Practices (CBPDA). Published on July 28, 2025, the regulation applies tiered oversight to pharmaceutical manufacturers based on product risk, facility complexity, and compliance history.
Contents10 sections
Key Takeaways
- Risk-based framework: RDC 982/2025 replaces uniform inspection schedules with tiered oversight. Facilities are classified by product risk class, operational complexity, compliance history, and international audit status.
- Multiple certification pathways: CBPF and CBPDA certificates can now be granted through three mechanisms: analysis of Equivalent Foreign Regulatory Authority (AREE) inspection reports, risk assessment-based decisions, or physical ANVISA inspection triggered by risk factors.
- International audit recognition: Under IN 292/2024, ANVISA recognizes inspection reports from PIC/S and ICH member authorities. See our international harmonization coverage for related developments.
- Continuous monitoring: ANVISA maintains ongoing compliance surveillance and can cancel certificates at any time based on risk analysis, independent of certificate validity periods.
- Implementation timeline: The regulation took effect July 28, 2025, with full implementation rolling out in 2026 following Collegiate Board approval of operational procedures.
What Is ANVISA RDC 982/2025?
The Collegiate Board Resolution No. 982 of July 28, 2025 establishes health risk management criteria for pharmaceutical manufacturing and distribution certification in Brazil. The resolution covers APIs, finished pharmaceutical products, biological products, medical devices, and medicinal cannabis products.
ANVISA issues two certificate types under this framework:
| Certificate | Portuguese Acronym | Scope |
|---|---|---|
| Good Manufacturing Practices | CBPF | Manufacturing facilities for APIs, drugs, biologics, devices |
| Good Distribution/Storage Practices | CBPDA | Distribution and warehousing operations |
The regulation marks a shift from prescriptive inspection intervals to dynamic risk assessment. ANVISA can now adjust oversight intensity based on actual risk factors rather than calendar schedules alone.
How Does the Risk Assessment Work?
ANVISA evaluates establishments using 17 objective criteria defined in Article 3 of RDC 982/2025. These factors determine inspection frequency and certification pathways.
Why this matters: Companies with strong compliance records and international certifications may qualify for reduced inspection burden. Facilities with complex operations or compliance gaps face enhanced oversight.
The four primary risk axes are:
- Product risk class: Higher-risk therapeutic categories (such as injectables, biological products, and critical APIs) receive more scrutiny than lower-risk product categories.
- Establishment complexity: Factors include facility size, number of product lines, manufacturing technology, and operational scope.
- Compliance history: Clean inspection records and responsive corrective actions improve risk classification. Previous violations or incomplete remediation increase risk scores.
- International audits: Valid inspection reports from recognized foreign authorities count favorably in risk assessment.
What Are the Certification Pathways Under RDC 982/2025?
Article 4 of the resolution establishes three mechanisms for CBPF and CBPDA issuance or renewal:
Pathway 1: Foreign regulatory report analysis. For facilities with inspection reports from Equivalent Foreign Regulatory Authorities (AREEs), ANVISA may grant certification based on document review. This pathway uses the IN 292/2024 framework for regulatory reliance.
Pathway 2: Risk analysis. ANVISA conducts a risk assessment using the Article 3 criteria. Companies with favorable risk profiles may receive certification without physical inspection.
Pathway 3: Risk-triggered inspection. When risk factors warrant direct verification, ANVISA conducts on-site or remote inspections to confirm compliance.
Companies may use different pathways for initial certification versus renewal, depending on their evolving risk profile and available documentation.
How Does ANVISA Recognize Foreign Regulatory Authorities?
The Normative Instruction No. 292 of May 2, 2024 defines criteria for designating Equivalent Foreign Regulatory Authorities (AREEs). ANVISA recognizes regulatory bodies that are:
- Members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- Members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
The European Medicines Agency (EMA) qualifies as a PIC/S-equivalent organization under the instruction. ANVISA designates AREEs at three confidence levels:
| Level | Description | CBPF Process |
|---|---|---|
| Partial Reliance | Full review of AREE inspection reports | Optimized analysis with complete document review |
| Full Reliance | Simplified review of AREE reports or partial certificate acceptance | Streamlined assessment with reduced documentation requirements |
| Mutual Recognition | Automatic acceptance of AREE certificates and reports | Certificate or inspection report adopted bilaterally via Mutual Recognition Agreement (MRA) |
Mutual Recognition Agreements require completion of a Confidence Building Program between ANVISA and the foreign authority, followed by Collegiate Board deliberation.
Which Companies Must Comply With RDC 982/2025?
The regulation applies to all establishments performing manufacturing, distribution, or storage activities for:
- Active pharmaceutical ingredients (APIs/IFAs)
- Finished pharmaceutical products
- Biological products
- Medical devices
- Medicinal cannabis products
This includes:
- Domestic Brazilian manufacturers
- Foreign API and drug product manufacturers supplying Brazil
- Pharmaceutical distributors and wholesalers
- Import-oriented distribution operations
- Storage facilities handling regulated products
Foreign manufacturers must work through a Brazilian legal representative who assumes responsibility for GMP certification procedures and product compliance.
What Continuous Monitoring Requirements Apply?
Article 6 of RDC 982/2025 establishes ongoing compliance monitoring independent of certificate validity periods. ANVISA maintains surveillance through:
- Review of company-submitted information
- ANVISA database cross-referencing
- External data source monitoring
- Post-market surveillance data
Monitoring findings may trigger inspection at any time, regardless of current certificate status. ANVISA may also initiate investigations or cancel certificates based on risk analysis without waiting for scheduled renewal dates.
What to watch next: ANVISA will issue technical guidance detailing the specific weighting methodology for each risk factor. This guidance will clarify how international audit documentation should be submitted and how risk classifications translate into inspection schedules.
How Does RDC 982/2025 Align With Global Regulatory Trends?
Brazil's shift to risk-based oversight follows patterns established by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other mature regulators. The PIC/S Guidance on GMP Inspection Reliance (PI 048-1) provides a framework that ANVISA's approach mirrors.
The regulation positions Brazil within international harmonization efforts. By recognizing PIC/S and ICH member inspections, ANVISA reduces redundant oversight while maintaining quality standards. This alignment may influence other Latin American regulators such as Mexico's COFEPRIS and Colombia's INVIMA to adopt similar reliance mechanisms.
For multinational pharmaceutical companies, RDC 982/2025 offers potential efficiency gains. Facilities with FDA inspections, EMA GMP certificates, or WHO prequalification can use these credentials to streamline Brazilian market access.
Frequently Asked Questions
What is ANVISA RDC 982/2025?
RDC 982/2025 is a Brazilian regulation published on July 28, 2025, that introduces a risk-based inspection system for Good Manufacturing Practices (CBPF) and Good Distribution Practices (CBPDA) certification. It replaces uniform inspection schedules with a tiered approach based on product risk, facility complexity, compliance history, and international audit recognition.
Which companies must comply with RDC 982/2025?
The regulation applies to all manufacturers and distributors of active pharmaceutical ingredients (APIs), finished pharmaceutical products, biological products, medical devices, and medicinal cannabis products operating in Brazil. This includes domestic facilities and foreign establishments supplying the Brazilian market.
How does the ANVISA risk-based inspection system work?
ANVISA evaluates four criteria: product risk class, establishment complexity, compliance history, and valid international audits. Lower-risk facilities with clean records and international certifications may receive extended inspection intervals. Higher-risk operations undergo more frequent oversight. Certification can now be granted through analysis of foreign regulatory reports, risk assessment, or physical inspection depending on the risk profile.
What is an Equivalent Foreign Regulatory Authority (AREE)?
AREE (Autoridade Reguladora Estrangeira Equivalente) refers to foreign regulatory bodies recognized by ANVISA as having equivalent standards to Brazilian requirements. Under IN 292/2024, ANVISA recognizes authorities that are PIC/S or ICH members. Inspection reports from AREEs can streamline CBPF certification through optimized analysis procedures.
When does RDC 982/2025 take effect?
The regulation was published on July 28, 2025, with full implementation rolling out in 2026 following Collegiate Board approval of operational procedures. Companies should prepare compliance documentation and conduct risk self-assessments to align with the new framework.
Primary Sources
- ANVISA. Collegiate Board Resolution No. 982 of 28 July 2025. Official English translation. Provides health risk management criteria and compliance monitoring for CBPF and CBPDA certification.
- ANVISA. Normative Instruction No. 292 of 2 May 2024. Establishes criteria for Equivalent Foreign Regulatory Authorities (AREE) and optimized analysis procedures for CBPF certification.
- ANVISA. Vote No. 301/2025/SEI/DIRE4/ANVISA. Technical proposal for CBPF prioritization matrix under RDC 982/2025, approved August 2025.
- PIC/S. PI 048-1 Guidance on GMP Inspection Reliance. International framework for regulatory reliance in pharmaceutical inspections, adopted June 2018.
- ANVISA. Good Manufacturing Practices Overview. Official guidance on CBPF certification procedures, international inspections, and regulatory requirements.
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