Svarch-Pérez AE, Molina-Gasman AM, Enríquez-Ríos N, Olivares-Trejo MP, Molina-Leza JF, Alcocer-Varela JC

Language: Spanish
References: 12
Page: 296-303
PDF size: 488.91 Kb.

ABSTRACT

Objective. Measure the efficiency in the issuance of health authorizations for drugs by analyzing the requests for procedures - inputs - and the issuance of opinions - outputs -, and their relationship with the modifications in the registration conditions in the last four years. Materials and methods. Review of the Comisión Federal para la Protección contra Riesgos Sanitarios automated database (SIIPRIS), supported with a grade 3 polynomial regression model to corroborate the validity of the observed trends. Results. There was an increase in the entry and exit of procedures between 2019 and 2022, punctuated by a reduction in these in 2020 and the first half of 2022. In 2022 the increase in completed procedures was greater than 200% compared to 2019 and between 2021 and 2022, the average time of procedures was reduced, doubling the percentage of those completed in less than 90 days and halving the percentage of those completed in less than 360 days. Conclusions. There is notable progress in efficiency linked to indicators such as the increase in review staff, process automation and adjustments in the internal organization. The challenge of closing the gap of unfinished procedures and completing them in less than 90 days on average persists.

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