Abstract

SANCHEZ GONZALEZ, Celeste Aurora. Respaldo de la reglamentación farmacéutica cubana para la intercambiabilidad terapéutica de los medicamentos genéricos. Rev Cubana Farm [online]. 2004, vol.38, n.1, pp. 1-1. ISSN 1561-2988.

A characterization of the Cuban Pharmaceutical Regulation during the last 24 years was made, starting from the international approach on the supporting requirements for the theapeutical interchangeability of generic drugs or of multiple sources. The standards established on the adequate manufacturing practices and quality control for drugs and for inspections as a way to check their fulfillment, on the registry of drugs as a health tool to control commercialization, where the characteristics of the pharmaceutical were evaluated in relation to the fulfillment of standing parameters to prove its quality, safety and efficiency, were approached. The regulations that should be fulfilled for the rotulation of and information about drugs and, particularly, the guidelines showing the therapeutic interchangeability and bioequivalence as specific guides for the generic products were identified. The institutional levels of the national health authorities of the legal instruments for the guidelines and regulatory actions protecting in a general way the equivalence and clinical substitution of the multiorigen pharmaceuticals were included. It was concluded that the normative level attained was satisfactory and it was shown a figure with the quantitative summary of the events regulating the time that evidence the platform of assurance for the therapeutical interchangeability of the generic drugs in our country.

Keywords : INTERNATIONAL COMMON DENOMINATION (ICD); COMMERCIAL NAMES OF DRUGS; GENERIC NAMES OF DRUGS; CUBAN REGULATIONS ON DRUG NAMES.