{"id":4334,"date":"2023-07-25T14:37:49","date_gmt":"2023-07-25T06:37:49","guid":{"rendered":"https:\/\/regask.com\/?p=4334"},"modified":"2024-10-26T02:49:58","modified_gmt":"2024-10-25T18:49:58","slug":"normas-de-seguridad-farmaceutica-de-los-mfd","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/mfds-pharmaceutical-safety-regs\/","title":{"rendered":"MFDS Propone Revisi\u00f3n Parcial de Reglamento sobre el Sa\u2026"},"content":{"rendered":"<div>\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div class=\"css-xdofzv\">\n<div id=\"alert__details__read__summary\" class=\"css-25930v\">\n<div><a href=\"https:\/\/www.mfds.go.kr\/eng\/index.do\" target=\"_blank\" rel=\"noopener\">Ministerio de Seguridad Alimentaria y Farmac\u00e9utica de Corea (MFDS)<\/a> Propuso una revisi\u00f3n parcial del Reglamento sobre la seguridad de los productos farmac\u00e9uticos mediante el Aviso de seguridad n.\u00ba 2023-333. A continuaci\u00f3n se presenta un resumen del proyecto propuesto:<\/div>\n<div><\/div>\n<ul>\n<li>Ampliaci\u00f3n del \u00e1mbito de reconocimiento de los datos presentados para el registro de materias primas de medicamentos (art\u00edculos 15 y 16)<\/li>\n<li>Los datos presentados sobre el sitio de fabricaci\u00f3n del medicamento de materia prima en el momento del registro del medicamento de materia prima se ampliar\u00e1n para incluir datos que certifiquen que los est\u00e1ndares de fabricaci\u00f3n y control de calidad del medicamento de materia prima son apropiados, o datos reconocidos por el MFDS como un certificado de fabricaci\u00f3n o un equivalente como tal.<\/li>\n<li>Reglamento sobre procedimientos y m\u00e9todos para la aprobaci\u00f3n del uso terap\u00e9utico de nuevos medicamentos en investigaci\u00f3n en el extranjero (art\u00edculo 28(2))<\/li>\n<li>Como el alcance de los nuevos medicamentos en investigaci\u00f3n sujetos a aprobaci\u00f3n para uso terap\u00e9utico se ha ampliado para incluir nuevos medicamentos en investigaci\u00f3n en el extranjero, se han preparado reglamentos sobre los procedimientos de solicitud y los documentos de presentaci\u00f3n.<\/li>\n<li>Regulaci\u00f3n de asuntos distintos de cambios menores que no requieren aprobaci\u00f3n de cambio de BPM (Art\u00edculo 48.3)<\/li>\n<li>Como los objetivos para cambios menores son m\u00ednimos y los objetivos para la aprobaci\u00f3n de cambios son amplios, los cambios significativos que pueden afectar la calidad del medicamento se determinan como distintos a cambios menores y est\u00e1n sujetos a la aprobaci\u00f3n del cambio.<\/li>\n<li>Reglamento sobre m\u00e9todos y normas de etiquetado de medicamentos y productos no farmacol\u00f3gicos para personas con discapacidad visual y auditiva (art\u00edculos 71(2), 75(2) y 75(3))<\/li>\n<li>Como ahora es obligatorio marcar c\u00f3digos Braille y de conversi\u00f3n audiovisual en medicamentos y cuasimedicamentos recetados por el MFDS para personas con discapacidad visual y auditiva, los reglamentos establecen m\u00e9todos y normas para dichas marcas, as\u00ed como el contenido y los m\u00e9todos de las encuestas y evaluaciones sobre su adecuaci\u00f3n.<\/li>\n<li>Reglamento sobre m\u00e9todos y procedimientos para el seguimiento en l\u00ednea de la venta ilegal de drogas (nuevo art\u00edculo 71.3)<\/li>\n<li>Una vez establecidas las bases para encomendar la vigilancia en l\u00ednea de las ventas ilegales de medicamentos, se ha preparado un reglamento sobre los m\u00e9todos y procedimientos de vigilancia.<\/li>\n<\/ul>\n<div>La consulta p\u00fablica est\u00e1 abierta hasta el 11 de septiembre de 2023.<\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-md-12\">\n<div class=\"jss1501\">\n<div class=\"jss1521\">\n<div class=\"jss409 jss434 summaryParagraph\">\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/es\/contacto\/\">Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios regulatorios en Corea del Sur.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-142495312\">\n\n\t<div id=\"col-768030974\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-farmacia-biotecnologia\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria farmac\u00e9utica y biotecnol\u00f3gica<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"MuiGrid-root jss1499 MuiGrid-item MuiGrid-grid-xs-12\">\n<div class=\"jss1500\">\n<div class=\"jss409 jss417 dataText\"><\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El Ministerio de Seguridad de Alimentos y Medicamentos de Corea (MFDS) propuso una revisi\u00f3n parcial de las Regulaciones sobre la Seguridad de los Productos Farmac\u00e9uticos a trav\u00e9s del Aviso de Seguridad N.\u00b0 2023-333. A continuaci\u00f3n, se incluye un resumen del borrador propuesto: Ampliaci\u00f3n del alcance del reconocimiento de los datos presentados para el registro de medicamentos a partir de materias primas (art\u00edculos 15 y 16) Los datos presentados sobre la\u2026<\/p>","protected":false},"author":39,"featured_media":4047,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,520],"tags":[40],"class_list":["post-4334","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-south-korea-regulations","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MFDS: Pharmaceutical Safety Updates | RegASK<\/title>\n<meta name=\"description\" content=\"The MFDS proposes revisions to pharmaceutical safety regulations. 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