Institutional
Institutional 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
Scope of action
Market authorization for products prior to its manufacturing, market exposure or delivery to consumers
Inspections to ensure manufacturing quality; products’ post-market and post-use activities (monitoring, oversight, complaints’ receipt, etc.)
Oversight to enforce compliance with sanitary regulations
Control of the import, export and circulation of ingredients and goods subject to health regulation
Health regulation actions in services for outpatient care (routine or emergency) and hospitalization; diagnostic support and therapeutic services that entail the incorporation of new technologies
Coordination of special programmes to monitor the quality of regulated products and services
Control actions in ports, airports and borders, to ensure the sanitary control of facilities, services and means of transportation, products’ import and the protection of travelers’ health
Adoption of preemptive and control measures for outbreaks, epidemics and public health emergencies