Case Study 63: Registration of Vaccines with Anvisa in Brazil

Company Situation

The Client is an Asia based global vaccine manufacturer with products marketed in 50+ countries. Client’s management had decided to expand its presence in Latin American countries, with initial focus on Brazil. Client needed a partner with regional presence in Brazil and experience in vaccines or biologics products registration in the country. Considering the business impact of multi-million USD, Client needed a partner that could provide end to end regulatory services.

GRP Solution

GRP was identified and retained by the Client as a partner of choice to meet its expansion needs in Latin America, starting with Brazil. GRP, with its local offices in Brazil has helped several biologic, vaccines products registration with ANVISA. Vaccines are registered as biologics in Brazil. GRP performed a thorough assessment of available studies and clinical data on the products, (the products were not registered in USA or Europe) and drafted an optimum regulatory strategy for their registration in Brazil. Client was interested in evaluating opportunities to reduce the time to market and identifying options for fast-track registration of vaccine in Brazil.

Based on GRP’s experience, the appropriate options were recommended to the client to register its vaccines in Brazil following the fast track pathway. GRP scheduled a consultation meeting with ANVISA to validate the proposed regulatory strategy for fast track. GRP prepared the meeting package working with Client teams and led the consultation meeting with ANVISA. Upon validation of strategy, GRP prepared the registration dossier in Portuguese and submitted it successfully to Anvisa for review. GRP further assisted client with applying for GMP audits by ANVISA and supported the client to be ready for such audits by performing GMP mockup audits. 

GRP’s office in Brazil was used as local representative for the application and primary distributor of vaccines in Brazil. Since GRP has authorized warehouse in Brazil, GRP supported Client with importation and storage of vaccine for further distribution through their marketing partners. GRP continues to act as Client’s local representative in Brazil, managing the life cycle of the vaccines and performing pharmacovigilance activities as well.

Services Offered :

Fast track registration of COVID-19 vaccine in Brazil

GRP White paper: FAst-track registration of COVID-19 vaccines in Brazil

On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .

Want to be updated on the Latest Regulatory Information

Follow GRP on Social Media !