Análisis crítico de la regulación medicamentos biológicos en el contexto colombiano con referencia a la normatividad internacional y propuesta de una guía general de evaluación

Abstract

El desarrollo de medicamentos de origen biotecnológico ha conllevado al replanteamiento y evolución de la normatividad en cada país con el fin de reglamentar la comercialización de medicamentos y así garantizar la seguridad, calidad y eficacia de los mismos. Con base en lo anterior, este trabajo pretende desde el punto de vista técnico y científico hacer una evaluación que permita desarrollar una propuesta de guía que proporcione una ágil y adecuada identificación de los requisitos generales exigidos y como estos pueden contribuir a certificar la calidad y seguridad de los productos que pretendan ingresar al mercado.De otro lado mediante un análisis retrospectivo de la dinámica de mercado, la diversidad de oferta y las diferencias entre diferentes normativas, la evaluación del posible impacto del establecimiento de esta reglamentación sobre el acceso a los medicamentos encontrando una dinámica favorable en este aspecto

Abstract. Medicines of biological and biotechnological origin are obtained from cells, tissue, animal fluids or plant viruses, microorganisms, toxins using methodologies rDNA, transgénesis, hybridoma, among others, as set forth in Decree 1782 of 2014 in their definitions. These have proven to be a new alternative in the treatment of diseases of high impact on health with less toxicity for its resemblance to the biological components and for which conventional chemical therapy, it has shown greater inherent adverse effects chemistry and low selectivity the therapeutic target. The development of drugs of biotechnological origin has led to rethinking and changing regulations in each country in order to regulate the marketing of medicinal and guarantee the safety, quality and efficacy thereof. In this context, Colombia has not been the exception and issue in our country of Decree 1782 of 2014 which establishes the health requirements and the procedure for pharmacological evaluation and pharmaceutical biological medicinal products for processing health record is the sign of this situation. On the other hand, due to the high cost of these medicines, governments have shown great concern to generate strategies that ensure access as part of citizens' rights. Based on the above, this work aims from the point of technically and scientifically makes an evaluation to develop a proposal for a guide that provides a quick and accurate identification of the required general requirements and how they can contribute to certify the quality and safety products seeking to enter the market. On the other hand through a retrospective analysis of market dynamics, diversity of supply and the differences between different laws, assessing the possible impact of the establishment of this regulation on access to medicines finding a favorable dynamic in this regard