Better practices in the National Authority for updating the Cuban regulation for medical products

Abstract

Objective: To identify the necessary improvements to the control of the regulation and to the planning of the update and elaboration of regulatory provisions. 

Methods: Descriptive, longitudinal and retrospective study with information from internal sources from 2018 to 2022 analyzed with brainstorming techniques and expert criteria. Implementation was measured during the first ten months of 2022. 

Results: Were identified the need to expand the control and characterization of regulation as a reference line to evaluate impact of improvements, and lack of methodologies with uniform criteria for the selection, evaluation and approval of the regulations to be updated and developed. The regulation database was characterized in terms of current status and number of editions. An application was created to automatically generate the information. A priority algorithm with five aspects was designed that included the mandatory evaluation of the alignment with international trends and regulations of specific references. The use of the methodology was formalized and two efficiency indicators were developed, the measurement of which yielded very satisfactory results. 

Conclusions: The improvement and sustainability of the control of the regulatory base and the new priority algorithm of the methodology for the elaboration of standards, contribute to optimize the planning practices of the regulatory update and ensure a more effective response to the current global regulatory demands.