When it comes to regulating agencies, the United States’ FDA is tough, yet the Brazilian ANVISA has been said to be ‘even tougher’. FDA’s main focus of regulating is on the reviewing of documentation where ANVISA spends its time focusing on the live operations and the conditions of facility. The reason that ANVISA takes this approach and doesn’t only focus on the documentation is to ensure they can witness everything. This gives the agency a chance to see what goes on in the facility on a daily basis.

ANVISA and FDA don’t only differ on the type of regulatory compliance reviews they focus on, but they differ on warning notices as well. To read more about the difference of the two agencies click here.

Want to launch into Brazil and need help? Thinking of whether to use ANVISA or FDA? Our excellent staff can help. Contact us at contact@pathways.com!