Brazil Drug Registration and Approval process

Pharmaceutical Regulatory Affairs in Brazil- Overview

Drug registration and approval process in Brazil is governed by a high-quality Regulatory system that constantly updates its standards, driven by the belief that healthcare is a constitutional right. This commitment to excellence has propelled Brazil to become the largest pharmaceutical market in LATAM, and it also holds a prominent position globally, ranking sixth among the largest pharma markets with a total share of 2.6%. Over the past decade, Brazil's pharma industry has experienced steady growth, making it an attractive ground for investments with the potential for substantial returns. With Brazil’s strong ANVISA Regulatory guidelines in place, companies entering the market can rely on a well-structured framework for drug registration and approval in Brazil.

The Agência Nacional de Vigilância Sanitária (ANVISA) is the drug Regulatory Authority under the Health Ministry in Brazil. The ANVISA is a part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products & services subject to Brazil pharmaceutical regulations, including related environments, processes, ingredients, and technologies, as well as control in the ports, airports, and borders.

Freyr supports Regulatory Affairs in Brazil by assisting clients with drug registration in Brazil, acting as a Legal Representative in Brazil, and enabling successful market access through Regulatory Affairs Consulting in Brazil.

Freyr for Brazil – Regulatory Affairs Support

• Representing as RA CMC in Health Authority Meetings
• Interacting with the ANVISA
• Regulatory Affairs Consulting in Brazil
• Strategically Handling the HA Queries and Preparing Response Packages
• Query Support Management
• Lifecycle Management Support

Medicinal Product Classification in Brazil

• Synthetic Drugs
• Generic Drugs
• Similar Drugs
• Potentized Medicines
• Specific Medicines
• Notified Medicines
• Over-the-counter (OTC) Drugs
• Herbal Medicines
• Medicinal Gases
• Biologic Products
• Radiopharmaceuticals

Understanding medicinal product classification in Brazil is critical before initiating the drug registration process in Brazil.

Drug registration and approval process in Brazil

After the classification of the medicinal product, an application should be submitted to the ANVISA for the registration of the pharmaceutical product in compliance with Brazil Pharmaceutical Regulations. It is necessary for a foreign entity that does not have any local presence to appoint a local agent. The agent acts as a Market Authorization Holder (MAH) in Brazil, who acts as a local agent responsible for the licensing of drugs and companies in Brazil and carries out the pharmaceutical product registration. The applicant should identify the subject code of their petition and file a petition. It is necessary to obtain documents like the sanitary license of the local agent, the Federal Sanitary License (AFE and/or AE), GMP certification, pharmacovigilance reports, clinical & nonclinical studies, chemical, manufacturing, quality control reports, product labeling in Portuguese, worldwide registration status report of the product, etc. These are a part of the registration dossier. Freyr supports the Brazil drug registration and approval process at ANVISA through the GAP analysis, review, compilation, & submission of the dossier, ensuring complete alignment with ANVISA Regulatory guidelines.

ANVISA carries out an expert evaluation of each document and generates a query, if necessary. It checks if the dossier satisfies the current regulation and meets Brazil's drug regulatory requirements. Once all the evaluations and inspections are done, the product is approved for Drug Brazil Market access or rejected.

Product Maintenance & Compliance

Brazil Drug Registration and Approval - Freyr Expertise

• End-to-end Drug Registration in Brazil.
• Product Classification Services, According to the ANVISA.
• Strategic Regulatory Guidance During Product Development & Pharmaceutical Regulatory Affairs in Brazil
• Carrying out Gap Analysis, Reviewing, & Submitting the Dossier to the ANVISA.
• Interpreting the Brazil pharmaceutical regulations and Developing the Regulatory Documentation.
• Representing as RA CMC in Health Authority Meetings.
• Interacting with the ANVISA.
• End-to-end Regulatory Affairs Support in Brazil with flexible engagement models
• Acting as Legal Representative in Brazil
• Regulatory Affairs Consulting.
• Strategically Handling the HA Queries and Preparing Response Packages.
• Query Support Management.
• Lifecycle Management Support, including Product Maintenance and Compliance
• Managing Artwork & Labeling Requirements.
• Assisting with post-registration changes (variations) of drugs in Brazil, including documentation, submission, and follow-up with ANVISA