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Regulatory pathways for approval of biological products in Brazil

04:28 EDT 22 Sep 2017 | Generics and Biosimilars Initiative

Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’.

Original Article: Regulatory pathways for approval of biological products in Brazil

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