Resumo

SANCHEZ GONZALEZ, Celeste Aurora. Grand-national Project ALBASALUD for Regulatory Center of Essential Drugs for the ALBA-TCP countries. Rev Cubana Farm [online]. 2011, vol.45, n.3, pp. 321-330. ISSN 0034-7515.

The Drug Regulatory Authority of Cuba is coordinating a Project of the Bolivarian Alliance for the Peoples of America- Free Trade Agreement (ALBA-TCP) aimed at developing a Regulatory Center that will operate as a new regional body of pharmaceutical integration for the ALBA countries. It will provide a Grand-national Register that will be valid for all the member states to facilitate the access to quality essential drugs. The objective of this research work was to design and to conduct a project from the technical viewpoint in order to lay down the legal and methodological basis of the future center and its main functions. Some techniques like nominal group, points of reference and expert consultation were used, and the specific methodologies to plan and to prepare the required documents were devised. The guidelines of international regulatory bodies, the basic groups of drugs and the pharmaceutical regulations of the participating countries were reviewed. Several documents and strategies for the project work in the pre-investment stage were developed, the first listing of essential drugs for the ALBA countries was defined and the main legal provisions and the regulation that states the functions of registering, surveillance, supervision, lab work and release of batches of the new entity were approved. The Grand-national Project ALBASALUD " Regulatory Center of Drugs for the ALBA-TCP" has proved its efficiency and capacities to achieve the set objectives through collective involvement-supported scientific and technical work that has guaranteed the required provisions and guidelines for the basic functions and the legal endorsement of the center.

Palavras-chave : pharmaceutical integration initiatives; systems and centers of drug regulation; grand-national register of essential drugs.

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