Brazil Drug Registration and Approval - Overview
In Brazil drug registration and approval are 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.
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 health regulation, including related environments, processes, ingredients, and technologies, as well as control in the ports, airports, and borders.
Freyr assists with drug registration in Brazil, in addition to Regulatory affairs consulting and pharma market access effectively.
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
Medicinal Product Registration in Brazil
After the classification of the medicinal product, an application should be submitted to the ANVISA for the registration of the pharmaceutical product. 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) 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. Subsequently, the GAP analysis, review, compilation, & submission of the dossier is carried out.
ANVISA carries out an expert evaluation of each document and generates a query, if necessary. The ANVISA checks if the dossier satisfies the current regulation. Once all the evaluations & inspections are done, the product is approved for pharma market access or is rejected.
Product Maintenance & Compliance
Validity of Registration Certificate
Post-approval Changes (Variations)
Ten (10) years
The renewal application must be submitted six (06) months before the expiration of the existing registration certificate, along with documents mentioned in the format given in RDC 317/2019.
Any change of registered medicine must be sent to the ANVISA with relevant documents in accordance with the current requirements.
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 & Regulatory Affairs Support.
- Carrying out Gap Analysis, Reviewing, & Submitting the Dossier to the ANVISA.
- Interpreting the Regulations and Developing the Regulatory Documentation.
- Representing as RA CMC in Health Authority Meetings.
- Interacting with the ANVISA.
- Regulatory Affairs Consulting.
- Strategically Handling the HA Queries and Preparing Response Packages.
- Query Support Management.
- Lifecycle Management Support.
- Managing Artwork & Labeling Requirements.