Revisión bibliográfica de normas técnico-legales para el registro y control de productos biológicos y propuesta de reglamentación nacional 2012
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2012-12
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Universidad de Guayaquil. Unidad de Postgrado, Investigación y Desarrollo
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El principal objetivo es establecer, mediante revisión bibliográfica, las Normativas Técnico-Legales para el Registro y Control de Productos Biológicos en el Ecuador y propuesta de Reglamentación Nacional 2012. La finalidad será proteger la salud pública a través del control de la calidad de los medicamentos; dada en la Constitución de la Republica del Ecuador, Ley Orgánica de Salud, indicando que la autoridad sanitaria a través de su organismo técnico el Instituto de Higiene y Medicina Tropical será el que otorgara el certificado de Registro Sanitario. Mediante acuerdo No 00000586 publicado en el Registro Oficial No 335, 7 diciembre 2010 se expidió la reforma al reglamento de Registro Sanitario para Medicamentos que no contempla los requisitos correspondientes para el Registro de medicamentos de origen biológico y por la complejidad de estas moléculas. El método fue la recopilación de las Normativas y Reglamentos Internacionales para Productos Biológicos. Se realizó en el INHMT en el Proceso de Control de Biológicos e Inmunizantes. El periodo fue de un año. Los resultados serán puestos a consideración de la Dirección del Instituto, para análisis y discusión interna, luego externa, involucrándose a representantes de la industria, para plantearlas como borrador de Normativas a las autoridades del MSP y, en base a ellas y a la experiencia Nacional, implementar la propuesta de Reglamentación Nacional para Productos Biológicos.
The main objective is to establish, through literature review, the Technical and Legal Regulations for the Registration and Control of Biological Products in Ecuador and proposed National Regulations 2012.'s Purpose is to protect public health through the quality control of medicines ; given in the Constitution of the Republic of Ecuador, Organic Health Act, indicating that the health authority through its technical body the Institute of Hygiene and Tropical Medicine which will grant the Sanitary Registration Certificate. By 00000586 No agreement published in the Official Gazette No 335, December 7, 2010 was issued to reform regulation of Health Registry for Drugs that includes the requirements for Registration of biologicals and the complexity of these molecules. The method was the collection of the International Standards and Regulations for Biological Products. Was performed in INHMT in Biological Process Control and Immunizing. The period was one year. The results will be put to consideration of the Director of the Institute for analysis and then external internal discussion, engaging with industry representatives to raise them as draft regulations to the authorities of the MSP and, based on them and the national experience, implement the proposed National Regulations for Biological Products.
The main objective is to establish, through literature review, the Technical and Legal Regulations for the Registration and Control of Biological Products in Ecuador and proposed National Regulations 2012.'s Purpose is to protect public health through the quality control of medicines ; given in the Constitution of the Republic of Ecuador, Organic Health Act, indicating that the health authority through its technical body the Institute of Hygiene and Tropical Medicine which will grant the Sanitary Registration Certificate. By 00000586 No agreement published in the Official Gazette No 335, December 7, 2010 was issued to reform regulation of Health Registry for Drugs that includes the requirements for Registration of biologicals and the complexity of these molecules. The method was the collection of the International Standards and Regulations for Biological Products. Was performed in INHMT in Biological Process Control and Immunizing. The period was one year. The results will be put to consideration of the Director of the Institute for analysis and then external internal discussion, engaging with industry representatives to raise them as draft regulations to the authorities of the MSP and, based on them and the national experience, implement the proposed National Regulations for Biological Products.
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Revisión bibliográfica, Productos biológicos, Prevención, Legislación, Registro sanitario, Calidad de los medicamentos, Propuesta de reglamentos, Salud pública, Ecuador, Instituto Nacional de Higiene y Medicina Tropical (INHMT), Cantón Guayaquil