Contributing Factors for the Performance of Generic Drug Development Projects

Generic drugs represent significant part of the Brazilian
pharmaceutical market, playing a major role in its health system. Recent studies
show that a significant portion of applications for registration of new generic
drugs is denied. These results gave rise to the question of this research, which
sought to identify which factors contributed to the failure of the generic drug
development projects (GDDP) in Brazil. The data collected through an
electronic questionnaire were analyzed using the structural equation modeling
method with partial least squares estimation (PLS-SEM). The results validate 5
indicators for the performance of the GDDP and 44 indicators for the
contributing factors classified into three dimensions: Managerial, Structural and
Technical. The results also indicated that management difficulties contributed
directly to the performance of the GDDP. However, the contributions of
technical difficulties and structural difficulties had only confirmed their indirect
effects through mediation by managerial difficulties.