Drug Product Registration in Brazil
Brazil presents a substantial opportunity for pharmaceutical firms. Yet, entering the market successfully requires an in-depth grasp of the regulatory ecosystem under the Agência Nacional de Vigilância Sanitária (ANVISA) and tailored execution for regulatory approvals. At DDReg, we specialise in Brazil drug registration services, helping global sponsors and local firms alike to navigate product approvals, generics registration and lifecycle compliance in Brazil.
ANVISA Drug Registration Process in Brazil for Global Companies
Brazil stands as one of Latin America’s most dynamic and stringently regulated pharmaceutical markets, a vital destination for companies seeking sustainable market access in the region. Governed by ANVISA (Agência Nacional de Vigilância Sanitária), Brazil’s regulatory ecosystem features well-defined pathways for the registration of new drugs, generics, similar products, and biologics, ensuring quality, safety, and efficacy standards are upheld.
ANVISA’s drug approval framework provides structured and transparent timelines, typically 365 days for standard reviews and as short as 120 days for priority or fast-track applications. Each registration (Registro de Medicamentos) is valid for 10 years, after which renewal is mandatory.
For foreign companies, the appointment of a locally established representative or Brazilian Registration Holder (BRH) is a regulatory requirement. This partner manages dossier submissions, liaises with ANVISA, oversees importation, and ensures compliance with post-market surveillance obligations.
Given its regulatory maturity and market scale, Brazil serves not only as a standalone market but also as a regional hub for Latin America. Successful pharmaceutical product registration in Brazil thus becomes a strategic milestone, opening doors to broader regional commercialization and cross-market reliance opportunities.
Our Services for Drug Registration in Brazil
We provide full-spectrum support for pharmaceutical products registration in Brazil, tailored to your needs. Our service offerings include:
- End-to-End Drug Registration in Brazil
- Product Classification Services aligned with ANVISA regulations
- Strategic Regulatory Guidance throughout Product Development
- Regulatory Affairs Consulting for Pharmaceutical Products in Brazil
- Gap Analysis, Dossier Review, and Submission to ANVISA
- Preparation and Publishing of Registration Dossiers (CTD/eCTD formats)
- Local Representation and Authorized Agent Support for Foreign Companies
- Interpretation of Brazil Pharmaceutical Regulations and Documentation Development
- Direct Liaison and Communication with ANVISA
- Strategic Query Management and Preparation of Response Packages
- Lifecycle Management & Post-Approval Support (renewals, variations, updates)
- Management of Artwork, Packaging, and Labeling Requirements
- Regulatory Intelligence and Monitoring of ANVISA Updates
- Import License and Market Authorization Support
- Compliance Support for Pharmaceutical Product Maintenance
- GMP Certification and Site Master File Support for Foreign Manufacturers
- Technical Dossier Auditing and Regulatory Remediation
- Regulatory Translation and Document Localization for ANVISA Submissions
Why Work with DDReg for Brazil Drug Registration?
- Regulatory Expertise: Deep knowledge of Brazil’s statutes (e.g., Law 6.360/1976, RDCs for drugs) and recent updates.
- Local & Global Blend: We combine global best-practice in regulatory affairs with local execution across Brazil’s regulatory environment.
- Accelerated Pathways: We help identify priority review, reliance, or generics routes to optimise time to market.
- Full Lifecycle Support: Comprehensive support across pre- and post-approval stages for seamless regulatory compliance.
Beyond approval, we assist with renewals, variations, compliance and post-market obligations.