From a government health body in Brazil to one of the most respected regulatory agencies in the world. The National Health Surveillance Agency (Anvisa) was created by Law 9,782, of January 26, 1999, to meet the popular desire for more safe consumption of products and services and has become an indispensable tool for the Unified Health System (SUS). ). Its first president was the renowned public health expert Gonzalo Vecina Neto.
The entity was born in a period marked by important transformations in the country, such as the implementation of the 1988 Federal Constitution, the opening to the globalization process and the stabilization of the economy with the consolidation of the Real Plan.
Before Anvisa, there was the National Health Surveillance Secretariat which had a precarious structure in technical-administrative terms and number of employees. There were no clear and transparent guidelines, registration analysis was carried out without technical-scientific depth, the demand for registrations and post-registrations was high and the body was under pressure from the regulated sector to meet them.
This precarious situation and the scandals involving medicines, such as the Androcur counterfeit case; the deaths of chronic kidney patients due to the use of contaminated water by a dialysis unit in Caruaru (PE); the circulation of counterfeit medicines in the country and the sale of contraceptive placebos (the case of the “flour pills”) forced the Government to take measures for greater health control and security. It was in this context that the Agency was born.
Anvisa was inspired by the American model (Food and Drug Administration – FDA). Its creation was a historic milestone and a watershed for the country as it represented a significant change by establishing itself as an independent body, with political, administrative and technical autonomy.
Initially, to meet the need for professionals capable of joining the workforce, Anvisa established a consortium with the Pan American Health Organization (PAHO) to hire technicians. Only later was the first competition held.
Since its creation, technical training has been one of the greatest assets, counting on a team of competent and qualified professionals who spare no effort to carry out efficient work in favor of building the well-being of the Brazilian population. The quality of deliveries, combined with the adoption of and respect for best regulatory practices, has guaranteed excellence and recognition both from the regulated sector and from international agencies, such as the FDA and the European Medicines Agency (EMA), among other regulatory bodies.
Over more than two decades, Anvisa's work was marked by important actions that greatly contributed to the leap in the quality of medicines in Brazil. Highlights include the creation of generics, the establishment of a regulatory framework for the registration of biological products in 2002, the regulatory framework of 2003 and, more recently, the establishment of standards for advanced therapies and their registration pathways. Anvisa transformed the medicine sector in Brazil, always raising standards and prioritizing quality and safety.
Anvisa's mission is to promote and protect the health of the population, ensuring control of the production and use of all products and services that may affect it, such as medicines, medical products, health services, food, cosmetics, sanitizing products, tobacco products, pesticides, blood and blood products. Today, Anvisa regulates sectors of the Brazilian economy responsible for around 20% of the country's Gross Domestic Product (GDP).
Over these 25 years, observers of Anvisa's evolution can say that the institution has gone through several phases, from a certain isolation to the present day, when we can see its maturation marked by robust dialogue with the regulated sector and international alignment, which is shows quite positive.
Currently, Anvisa operates in regulatory convergence with the most influential authorities in the world, participating in relevant international entities, such as the International Council for Harmonization (ICH), the International Forum of Medicines Regulators (IPRF), the Pharmaceutical Inspection Cooperation Scheme (Pharmaceutical Inspection Co-operation Scheme – PIC/s), among others.
Anvisa's evolution is remarkable. In these times, we have a transparent Agency, open to dialogue and with a high technical level, compared in terms of quality with the main international regulatory agencies, even with a smaller staff.
Despite the notable reduction in its staff over the years, Anvisa still manages to maintain high levels of productivity, achieving notable development, such as regulatory production capacity, technical knowledge and the development of leadership that serves as a reference for other regulatory authorities at an international level.
Despite the impressive quality results and highly experienced technical staff, it is undeniable that there are challenges ahead, especially dealing with growing demand and meeting legal deadlines. However, we recognize that overcoming these challenges necessarily requires an increase in the number of professionals to enable even better deliveries.
In these 25 years, there is much to celebrate. There were years of learning and maturity that today provide open and transparent communication with the regulated sector.
For these and many other stories, on this day we want to honor and congratulate the entire Anvisa team.
Sources:
• Brazilian Association of Fine Chemical Industries (Abifina)
Peci A, Ramalho PIS, Pereira SFS.
• Institutionalizing regulocracy: an analysis of the historical trajectory of Anvisa Revista do Serviços Público (RSP), Brasília 74(3) 613–633 Jul/Sep 2023
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