Characterization of the regulations implemented by the Cuban national regulatory authority

Abstract

Introduction: The regulations for the field of medical products have special importance due to its relevant impact in human health.

Objective: Characterize the regulatory framework of the Center for the State Control of Drugs, Equipment and Medical Devices in the moment of the presentation of its dossier as national regulatory agency.

Methods: Descriptive, longitudinal and retrospective study of the juridical dispositions and technical existing rules from 1989 to 2021 organized according to the issuer and characteristics of its targets.

Results: The external juridical dispositions applied were 47 general ones, from 14 institutions, and 57 specific ones from 7 issuers.  The regulatory dispositions, issued by the center as legal and methodological bases for its function of regulations were four of three types. The referential sources for their own dispositions were 21, 13 of them from international agencies and eight from foreign authorities. Their targets by type of product were seven for drugs, eight for equipment and medical devices, and two that were enforceable to all the products. The issued and valid dispositions were 170, and they were published in its web site and in the bulletin called Ámbito Regulador.  The rules were acknowledged in three dispositions with 89 standards for drugs and biological products, and in two for equipment and medical devices with 627. The System of Quality Management applies 15 standards.

Conclusions: The regulatory framework of the Center for the State Control of Drugs, Equipment and Medical Devices when formalized its incorporation as national regulatory agency presents a large, transparent and organized regulation that protects the exercise of its functions for the products and processes under its scope, and also aligned with the international referents keeping control of external dispositions that it should implement.