Institucional relationship 

 

Anvisa, in order to carry out its institutional mission, acts in alignment with various governmental agencies. Among them are the Ministry of Health, the Ministry of Planning, Development and Management, the Ministry of Agriculture, Livestock and Supply, and control bodies such as the Federal Audit Office and the Ministry of Transparency. As the coordinator of the Brazilian Health Regulatory System (SNVS), the Agency has made efforts to promote greater integration and alignment with the regulatory bodies in States and Municipalities.

Following a worldwide trend, Anvisa pursues strategies to modernize the processes of issuing market authorization to regulated products, maintaining their quality, safety and efficacy. In this process, it is worth highlighting the following stakeholders: the regulated sector, in charge of delivering safe products and services; the National Congress, legislative body that should act based on qualified technical information; and the society, which must be increasingly aware of health risks and must be able to evaluate the products and services consumed.


Challenges

  • Simplification of critical working processes
  • Reduction of waiting times for granting market authorizations, performing inspections and issuing import licenses
  • Moving forward in promoting international regulatory convergence, consolidating advancements achieved, alignment to best practices, and joining harmonization initiatives
  • Reaching a workforce size compatible to the extent of the regulatory activity
  • Strengthening post-market and post-use vigilance models
  • Consolidating a service policy in accordance with good governance, access to information, transparency and communication values

International position

Anvisa aims at reaching the highest standards for sanitary regulation, in line with the best scientific evidence available to date. The results achieved in the last years show an advance in the international leading role of the Agency.

2016:     Becomes a member of International Council for Harmonization (ICH)

2015:    Controls performed by Anvisa for pharmaceutical ingredients are recognized as equivalent to those of the European Community

               Becomes member of International Cooperation on Cosmetics Regulation (ICCR)

2012:     Co-founds the International Medical Device Regulators Forum (IMDRF)

2010:     Meets all the necessary criteria to be recognized as a Regulatory Authority of Regional    Reference (NRArr) by the Pan American Health Organization (PAHO)