3 Sept 2019
Brazil Adopts New Good Manufacturing Practices for Medicines, New Regulatory Framework for Pesticides
The Brazilian Health Agency (ANVISA) recently approved new good manufacturing practices for medicines as well as a new regulatory framework for pesticides.
The new GMPs for medicines update a previous ANVISA resolution as well as 14 regulatory instructions on this matter, with the goal of ensuring safe access to medicines and improving Brazil’s regulatory framework for these products. The new rules are based on the guidelines of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/s), which is the most relevant global forum for the establishment of guidelines and training on pharmaceutical inspection. The main consumer markets for medicines are members of this scheme, including the United States, Canada, the European Union, Japan, Australia and South Africa. The objectives of the new GMPs include harmonising Brazilian GMPs with international standards, enabling Brazil to accede to PIC/s, and promoting the acceptance of Brazilian medicines in other markets.
The new regulatory framework for pesticides updates and clarifies the evaluation criteria and toxicological classification of pesticide products in Brazil. It also adopts significant changes to the labelling requirements for these products by requiring the use of information, warning language and pictograms that facilitate the identification of hazards to human life and health. The amendments are based on the standards of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and harmonise Brazil’s rules with those of countries in the European Union and Asia, thereby enhancing the commercial attractiveness of Brazilian products in international markets.
ANVISA also recently completed a toxicological reclassification of pesticides already registered in Brazil. A total of 1,942 pesticide products were evaluated by the agency and 1,924 of those were ultimately reclassified. ANVISA indicates that 43 products were reclassified as extremely toxic, 79 as highly toxic, 136 as moderately toxic, 599 as non-toxic, and 899 as unlikely to cause acute damage. An additional 168 products were categorised as “unclassified”. The reclassification was necessary as part of the new regulatory framework for pesticides.