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Revista Cubana de Salud Pública

versión impresa ISSN 0864-3466versión On-line ISSN 1561-3127

Resumen

ORTA HERNANDEZ, Santa Deybis. The Cuban drug regulatory authority. Experience gained and training offered to other Latin American agencies in authorizing clinical trials. Rev Cubana Salud Pública [online]. 2011, vol.37, n.1. ISSN 0864-3466.

The Department of Vaccines and Biologics in the World Health Organization has developed an evaluation tool to identify the condition of the regulatory functions and the training of drug regulatory authorities to comply with their functions. This article was intended to provide the drug regulatory agencies from the non-developed countries with the necessary training, so that they can successfully perform their basic function in giving authorization to clinical trials with vaccines. Literature from WHO, the International Conference of Harmonization, the European Union, the Council of the International Organization of Medical Sciences, the US Food and Drug Administration and other regulatory documents of interest was reviewed. Data related to those indicators evaluating the performance of the drug regulatory authorities in giving permission for clinical trials with vaccines were collected and the five indicators assessing the contents and function of these authorities, their characteristics and relevant aspects were described. Furthermore, a summary of the essential aspects of the clinical trials with vaccines according to the WHO guideline as well as the experience of the Cuban regulatory authority in authorizing the conduction of these clinical trials was provided. The Drug Regulatory Authority is the responsible for assuring that vaccines for human beings meet the regulatory requirements of the country in the first place, and then for the research, commercialization or introduction of the vaccine in the National Immunization Program.

Palabras clave : Center for the State Control of Drug Quality (CECMED); Drug Regulatory Authority; clinical trials with vaccines; basic function.

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