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 that Anvisa maintains relations with 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

With the aim at keeping the Brazilian regulatory framework up-to-date, as well as ensuring that the Brazilian context is included in the process of preparing the international references that will guide health regulation worldwide, Anvisa participates in the main forums for discussion and regulation of products and services subject to health regulation.

Anvisa's participation in bilateral, regional and international negotiations and regulatory convergence initiatives promotes the use existing international tools to assist the Agency in its role of regulating, monitoring and supervising products subject to health regulation. These activities aim at avoiding duplication of efforts and making the better use of available resources, with a focus not only on health protection and promotion, but also on the national economic development.

Anvisa is also an important player in Brazilian technical cooperation efforts. Technical cooperation in health regulation is an effective instrument for strengthening the regulatory capacities of all parties involved, promoting the exchange of experiences and the use of best regulatory practices carried out by different health authorities.

These are some of the main recent international achievements by Anvisa:

2016:    Becomes a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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)