Revisión crítica y análisis comparativo de los requerimientos normativos para la autorización de comercialización de productos naturales en diferentes países
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Saldarriaga Agudelo, Illiz Yurany
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De la población de países miembros de ICH, países de referencia para Colombia y países recomendados por un experto, se eligió una muestra por conveniencia de cinco países, a la que mediante una revisión sistemática, un estudio descriptivo observacional y un análisis comparativo se le evaluó el marco normativo para la obtención de registro de productos herbales medicinales en cada uno de los países incluidos en el estudio, lo que permitió que se lograra proponer unas equivalencias terminológicas. Se extractaron, se agruparon por tópicos y se compararon los requisitos solicitados para la obtención de registro en cada uno de los países incluidos en el estudio frente a Colombia y se encontró que las exigencias para este último país, en general, no eran tan variables con respecto a los demás países, pero si existe diferencias considerables en tópicos como seguridad y eficacia para estos productos, también se hallaron diferencias en cuanto a la trazabilidad del material vegetal activo.
Abstract. Of the population of ICH member countries, countries of reference to Colombia and countries recommended by an expert, were chose for convenience a sample from 5 countries, that by systematic review, a descriptive study and a comparative analysis was evaluated the regulatory framework for obtaining registration of herbal medicinal products in each of the countries included in the study, what allowed that was achieved propose some equivalent terms. Were extracted, were grouped by topic and were compare with the establish requirements for obtaining registration in each countries included in the study against Colombia. Was found that the requirements for this country, in general, were not as variables with relation to other countries, but was found considerable differences in topics such as safety and efficacy for these products. Was also found differences concerning to traceability of the active plant material.
Abstract. Of the population of ICH member countries, countries of reference to Colombia and countries recommended by an expert, were chose for convenience a sample from 5 countries, that by systematic review, a descriptive study and a comparative analysis was evaluated the regulatory framework for obtaining registration of herbal medicinal products in each of the countries included in the study, what allowed that was achieved propose some equivalent terms. Were extracted, were grouped by topic and were compare with the establish requirements for obtaining registration in each countries included in the study against Colombia. Was found that the requirements for this country, in general, were not as variables with relation to other countries, but was found considerable differences in topics such as safety and efficacy for these products. Was also found differences concerning to traceability of the active plant material.