Dec. 24, 2018
By Leonardo Gottems, reporter for AgroPages
The three agencies responsible for the registration of agrochemicals in Brazil signed a technical cooperation agreement for the development of the Integrated System of Agrochemicals (SIA). The goal of this unification is to shorten the registration deadlines for new active ingredients or post-patent generic products.
Currently, the average time for a generic registration is four years, while for new molecules, it can drag on for up to eight years. Much of this delay is due to the fact that each organ has its own bureaucracy and registration system isolated from the others.
The estimated cost for the implementation of the system is US$ 2.5 million, and the unification of the data should be completed in two years. The "Agrofit" database will be used as the starting point. This system, operated by the Ministry of Agriculture, has currently registered some two thousand products formulated, of which approximately 50% are generic.
The project to unify the agrochemical register was signed by the Ministry of Agriculture, Livestock and Supply (Map), the Brazilian Institute of Environment and Renewable Resources (IBAMA), and the National Agency of Sanitary Surveillance (Anvisa). Also participating in the initiative are the Brazilian Cotton Institute (IBA) and the Brazilian Cooperation Agency of the Ministry of Foreign Affairs and the Brazilian Association of Cotton Producers (Abrapa).
According to the Agricultural Defense Secretary of the Map, Luis Rangel, the Integrated Agrochemicals System will unify all requests for the registration of these existing products to MAPA, IBAMA and ANVISA. The advantages of the new system, which will work in two years, will be transparency and speed in the registration process.
"In two and a half years of the administration of Minister Blairo Maggi, there were a record of more than 1,100 more modern and less toxic products to the environment and human health," explained Rangel. Some 1,500 registration applications are still pending.