BRAZIL Trends and Developments Contributed by: Marianne Albers, Thais Fernandes and Mariana Vianna, Felsberg Advogados
Leveraging Foreign Authority Evaluations for Product Registration in Brazil and Simplified Registration for Companies Within the Same Economic Group In an effort to strengthen international co-oper- ation, standardise approval processes, and accelerate the registration of drugs, biologics and raw materials in Brazil, ANVISA has begun to leverage evaluations from foreign regulatory authorities (reliance). This approach significantly reduces the time required for the registration and post-registration processes with the Brazilian regulatory agency when a product has already been approved by foreign authorities. As a result, companies that have already received approval from agencies such as the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), the European Directorate for the Quality of Medicines & Healthcare (EDQM), the European Medicines Agency (EMA), Health Canada, the Swiss Agency for Therapeutic Prod- ucts (Swissmedic), or the World Health Organi- zation (WHO) gain a significant advantage when introducing the same product into Brazil. Additionally, Brazil offers a simplified registra- tion process for medicines that allows compa- nies within the same economic group to register and market the same medicine under different names, with a faster approval process. This procedure is known as the “clone registration process” .
The clone registration process is designed for medicines that share the same manufacturer, production line, technical and clinical reports, and the same composition as a medicine already registered through the standard process in Bra- zil. This mechanism is widely used by economic groups that have companies dedicated to mar- keting only similar or generic medicines, as the time for granting a clone registration is much shorter than in the regular process. Conclusion The Brazilian life sciences market is already one of the most significant in the world and is con- stantly evolving and improving to meet emerg- ing innovations. With an active and competent regulatory agency, Brazil’s increasing interaction with regulatory agencies from other countries is becoming more commonplace, providing great- er legal certainty and confidence for domestic companies seeking to explore international mar- kets, as well as for international companies look- ing to tap into the Brazilian healthcare market. As seen, the expected expansion spans across all life sciences sectors, with notable growth in cannabis products, cosmetics, public-private partnership for the transfer of technology, and clinical research.
62
CHAMBERS.COM
Powered by FlippingBook