Brazil's ANVISA lowers barriers for some product registrations

The National Agency for Health Vigilance (ANVISA), the medicines regulator in Brazil, has increased the list of health products which, because of lower risk, are subject to less rigorous rules to obtain the renewal of country registration.

The new arrangement includes 37 products in the simplified notification list, amongst which are folic acid, salts for oral hydration or rehydration and ferrous sulphate.

The president of ANVIS, Jarbas Barbosa, affirmed that the measure, apart from facilitating the introduction of new products to the market permits the Agency professionals to concentrate their efforts on the analysis of products considered to have a higher risk. “It is a step which will bring more agility in evaluation,” he said. With the new version, the number of products with simpler rules for obtaining ANVISA registration grows by 112. The list will be reviewed periodically. The last update was in 2009.