NRA’s moving towards convergence

National Regulatory Agencies (NRA) in Latin America are:

• Transitioning towards Convergence in Regulatory Systems Development guiding national regulatory policy.
• Prioritizing their regulatory legal frameworks, structure and quality management systems.
• Defining core regulatory functions based on national policy objectives.
• Cooperating with partner / reference NRAs for regulatory policy decision making, that is, leveraging regulatory processes as those taken by more well established / resourced NRAs.
• Strengthening National Regulatory Authorities for Medicines and Biologics for the qualification of regulatory authorities of regional reference.

Currently, there are seven regulatory authorities in the Americas that qualified as competent and efficient in the performance (Level 4 category) per WHO recommended regulatory functions:

1. Argentina (2009).
2. Brazil (2010).
3. Colombia (2010).
4. Cuba (2010).
5. México (2012).
6. Canada.
7. United States of America.

The key topics for alignment have included sharing safety data, developing a common pharmacopeia, recognizing reciprocal acknowledgement of clinical site and GMP inspections. There are several on- going Institutional development plans in process for: Costa Rica, Chile, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Paraguay, Trinidad & Tobago.