Abstract

SANCHEZ GONZALEZ, Celeste A  and  PEREZ MASSIPE, Rodrigo Omar. Evolución y perspectivas del registro de medicamentos en Cuba. Rev Cubana Farm [online]. 2002, vol.36, n.3, pp. 197-206. ISSN 1561-2988.

The health authorities in charge of authorizing the commercialization of drugs in Cuba from 1959 to 2001, as well as their subordination level were evaluated. The evolution of the normative and legal documents, which are the basis of the Drug Registry in Cuba and of its evaluation, was described in order to characterize the national approach of the requirements and procedures demanded to register a drug. Some stages in the evolution of the authorities were identified and those aspects considered as quality leaps in the development spiral of this activity were approached. Emphasis was made on the present situation and on the outlooks to guarantee the improvement of the normative and legal level of the Drug Control System.

Keywords : LEGISLATION, DRUG; DRUG AND NARCOTIC CONTROL; PRODUCT SURVEILLANCE, POST MARKETING.

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