SIPLA

Events

Workshops on regulatory fast track for pharmaceuticals, fertilizers, pesticides and food
17-10-2024 - 17-10-2024

To approach these possible designs, the actual regulatory system in Argentina and Brazil for fertilizers and pesticides was examined and compared. An overview of Mercosur regulations on the subject was also presented, as well as a brief comparison with other neighboring jurisdictions, such as Uruguay. Representatives of companies, such as the Brazilian public company EMBRAPA, were invited to discuss issues related to the regulation of fertilizers and pesticides, including aspects and processes which aren’t regulated yet or are in the process of being regulated. It was the case of the Brazilian Bioinputs Law, which is still going through Congress and has the potential to change the rules on fertilizers and pesticides.

Based on the theoretical framework developed by the WHO, the workshop aimed to determine the degree of development of national regulations in each country concerning the use of regulatory decisions from other jurisdictions (reliance) in national drug registration procedures. The Uruguayan experience was deeply examined and was compared to other countries’ systems. The role of reliance procedures for the access of medicines within the Latin America region was also a topic discussed during the workshop. 

IMPRESSIONS