Abstract
To register a generic drug in Brazil, three pilot batches (PB) of the drug product are manufactured. All studies to prove the safety, efficacy, and quality of the drug are performed with these batches. There is constant concern about the equivalence between these batches and the commercial product. In Brazil, minimum PB of solid oral dosage forms, must be at least 50,000 units, although internationally, it is 100,000. The objective of this study is to provide an overview of registration and post-approval of generic drug products in solid oral dosage form using PB in Brazil, during 2010–2013. Among the 90 generic drug processes analyzed, 36% were registered with batches smaller than 100,000 units. Regarding PB size, we found an opportunity to improve IN 02/2009 through the establishment of a new minimum amount of units produced (100,000). This new minimum amount may increase the assurance that the registered medicines using PB represent the same commercially marketed lots.
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