The GRRO Brazil Subgroup of the GRRO leads outreach to industry groups 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 conducts outreach to 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 presentations of 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.
12 March 2020
The PBE Working Group and GRRO Brazil presented a webinar, “Review on the Population Bioequivalence Criterion” to Anvisa on March 12. The webinar had over 80 attendees from Anvisa and industry.
IPAC-RS met with Dr. Gustavo Mendes Lima Santos to discuss the newly issued Resolution RDC 278/2019 and Normative Instruction 33.
IPAC-RS and Anvisa co-authored and published Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products (AAPS Pharm Sci Tech, August 2019).
In June 2019, GRRO Brazil provided comments on Resolution RDC 278/2019 and Normative Instruction 33 that were published by Anvisa in April 2019.