The Brazil Subgroup of the GRRO leads outreach to industry and regulatory agencies in Brazil with the goal of building relationships with those organizations to support advancement of sound scientific approaches and regulations for OINDP in Brazil.
The GRRO Brazil Subgroup conducts research and develops material for educating IPAC-RS members on current/emerging regulatory and technical topics relevant to OINDP in Brazil. The Subgroup is also the entity within IPAC-RS that is developing contacts with regulators within ANVISA, the Brazilian pharmaceutical regulatory agency and with Brazilian standard setting bodies and other organizations as appropriate and needed. The Subgroup will lead IPAC-RS commenting on any OINDP relevant regulatory guidelines, standards and other documents; and plans to present IPAC-RS perspectives and scientific output at targeted forums relevant to the Brazilian OINDP regulatory arena. The Subgroup also collaborates actively with other IPAC-RS working groups to develop and convey consortium perspectives on scientific/regulatory issues to Brazilian agencies and organizations.
The Global Regulatory Review and Outreach Brazil Group continues to develop a strategy for providing ANVISA with scientific information on topics identified as priorities by the ANVISA regulators, especially around in-vitro testing. Previously, ANVISA indicated its intention to issue a guidance for inhalation products by the end of 2014.