Your Trusted Partner for Pharmacovigilance Support in Brazil
If you’re a pharmaceutical company, medical device manufacturer, or clinical research organization entering Brazil’s regulated market, having the right pharmacovigilance services in Brazil is essential.
At DDReg, we provide comprehensive Brazilian pharmacovigilance services, combining global expertise with deep local regulatory understanding. From QPPV services in Brazil to PV outsourcing, our team ensures your products meet ANVISA’s Good Pharmacovigilance Practices (GVP) and patient safety standards.
Understanding Pharmacovigilance Services for the Brazil Market
The Agência Nacional de Vigilância Sanitária (ANVISA) defines pharmacovigilance as “the science and activities related to identifying, evaluating, understanding, and preventing adverse effects or any other drug-related problems.”
To strengthen post-marketing surveillance and patient safety, Anvisa mandates Marketing Authorization Holders (MAHs) to maintain a structured pharmacovigilance system. This includes appointing a Local Qualified Person for Pharmacovigilance (LQPPV or LCPPV), maintaining a Brazil-specific Pharmacovigilance System Master File (PSMF), and reporting all adverse drug reactions (ADRs) via the VigiMed platform.
QPPV / LQPPV / LCPPV Requirements in Brazil
Under Resolution RDC No. 406/2020, every MAH must designate a Pharmacovigilance Officer responsible for establishing and maintaining the company’s PV system in Brazil.
Key Requirements:
- The officer (equivalent to a QPPV) must reside in Brazil and act as the primary contact with Anvisa for all PV matters.
- They are accountable for compliance with Good Pharmacovigilance Practices (GVP), including the collection, evaluation, and reporting of adverse events related to marketed medicines.
- Their qualifications, responsibilities, and delegation limits are specified in Anvisa’s regulatory framework and must be documented in the company’s PV system.
- The QPPV/LQPPV/LCPPV is responsible for ensuring the safety profile of all products and maintaining timely reporting to VigiMed.
Key Normative Documents Governing Pharmacovigilance in Brazil
Resolution RDC No. 406/2020Defines Good Pharmacovigilance Practices (GVP) for MAHs and outlines roles, system requirements, and reporting timelines.
Normative Instruction No. 63/2020Specifies the format and submission of the Periodic Benefit-Risk Evaluation Report (PBRER), including frequency and content aligned with ICH E2C(R2).
Guidelines on Regulatory Reliance (2024)Introduced by Anvisa to streamline approval processes for drugs, biologicals, and vaccines by leveraging reviews from equivalent foreign regulatory agencies, improving efficiency while maintaining high safety standards.
Together, these frameworks ensure that Brazil’s pharmacovigilance system remains harmonized with international best practices while safeguarding local patient populations.
Our Pharmacovigilance & Drug Safety Services in Brazil Include
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Individual Case Safety Reports (ICSR) Management
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Aggregate Safety Reporting
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Signal Detection & Risk Management
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PV System Setup, Maintenance & Audit Support
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QPPV and Local Pharmacovigilance Support
Why Choose DDReg as Your Pharmacovigilance Company in Brazil?
As a global regulatory science and drug-safety firm, DDReg acts as your local pharmacovigilance partner in Brazil, combining global experience with in-country operational capability. With evolving requirements such as RDC 967/2025 (effective March 2026) mandating E2B(R3) data standards and MedDRA/WHODrug coding, partnering with an expert PV firm is crucial.
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