{"id":9193,"date":"2025-11-18T16:08:53","date_gmt":"2025-11-18T08:08:53","guid":{"rendered":"https:\/\/regask.com\/?p=9193"},"modified":"2025-11-18T16:08:53","modified_gmt":"2025-11-18T08:08:53","slug":"la-hsa-de-singapur-publica-una-regulacion-actualizada-sobre-los-suplementos-de-salud-y-sus-ingredientes-prohibidos-y-restringidos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/singapores-hsa-issues-updated-health-supplement-regulation-on-prohibited-and-restricted-ingredients\/","title":{"rendered":"La HSA de Singapur publica una normativa actualizada sobre suplementos de salud\u2026"},"content":{"rendered":"<p><strong>El 29 de octubre de 2025<\/strong>, el <a href=\"https:\/\/www.hsa.gov.sg\/\"><strong>Autoridad de Ciencias de la Salud (HSA)<\/strong><\/a><strong> de Singapur<\/strong> public\u00f3 directrices actualizadas que rigen <strong>Ingredientes prohibidos y restringidos en suplementos de salud (HS) y medicinas tradicionales (MT)<\/strong>. La actualizaci\u00f3n fortalece la claridad regulatoria y las expectativas de seguridad para las empresas globales involucradas en la formulaci\u00f3n, fabricaci\u00f3n y distribuci\u00f3n de suplementos de salud.<\/p>\n<div class=\"row\"  id=\"row-1635665942\">\n\n\t<div id=\"col-726509608\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Descripci\u00f3n general de la actualizaci\u00f3n<\/strong><\/h3>\n\t<div id=\"gap-232711938\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-232711938 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La versi\u00f3n revisada <strong>Regulaci\u00f3n de los suplementos de salud de la HSA<\/strong> describe qu\u00e9 sustancias son <strong>prohibido<\/strong>, que son <strong>restringido<\/strong>, y qu\u00e9 obligaciones deben cumplir los distribuidores para garantizar la seguridad del producto. Las directrices se aplican a <strong>importadores, fabricantes, distribuidores mayoristas y vendedores<\/strong> de suplementos de salud y medicinas tradicionales de todo el mundo que se distribuyen en Singapur.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-726509608 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-507215142\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Detalles de las normas actualizadas sobre ingredientes prohibidos y restringidos<\/strong><\/h3>\n\t<div id=\"gap-719418893\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-719418893 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las directrices confirman que <strong>sustancias prohibidas<\/strong> incluyen aquellos definidos en el <a href=\"https:\/\/sso.agc.gov.sg\/Act\/PA1938\"><strong>Ley de venenos de 1938<\/strong><\/a> y <a href=\"https:\/\/sso.agc.gov.sg\/Act\/MDA1973\"><strong>Ley de 1973 sobre el uso indebido de drogas<\/strong><\/a>, as\u00ed como los ingredientes <strong>derivado de partes humanas<\/strong> y sustancias reguladas por la <a href=\"https:\/\/sso.agc.gov.sg\/Act\/ESIEA2006\"><strong>Ley de Especies en Peligro de Extinci\u00f3n<\/strong><\/a>, a menos que est\u00e9 espec\u00edficamente permitido.<\/p>\n<p>La actualizaci\u00f3n tambi\u00e9n establece condiciones estrictas para <strong>ingredientes restringidos<\/strong>, como <strong>l\u00edmites m\u00e1ximos de dosis diaria<\/strong> y <strong>requisitos de etiquetado obligatorios<\/strong>, que se detallan en <strong>Anexo A<\/strong>.<br \/>\nSustancias identificadas como que tienen <strong>posibles preocupaciones de seguridad<\/strong> exigir a los distribuidores que <strong>Monitorear los comentarios de los consumidores<\/strong> y aplicar medidas adecuadas <strong>medidas de mitigaci\u00f3n de riesgos<\/strong>, como se indica en <strong>Anexo B<\/strong>.<\/p>\n<p>Para cumplir, los distribuidores deben realizar <strong>evaluaciones de seguridad<\/strong>, mantener <strong>evidencia de seguridad del producto<\/strong>, asegurar <strong>etiquetado adecuado<\/strong>, y reportar <strong>efectos adversos<\/strong> asociado con productos que contienen sustancias reguladas.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-507215142 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-411080802\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Fecha l\u00edmite para comentarios<\/strong><\/h3>\n\t<div id=\"gap-1373745141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1373745141 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Hay <strong>No hay fecha l\u00edmite para comentarios<\/strong> asociado con esta actualizaci\u00f3n regulatoria.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-411080802 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-133221346\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Fecha de entrada en vigor<\/strong><\/h3>\n\t<div id=\"gap-1729956880\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1729956880 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las directrices actualizadas entraron en vigor en <strong>Octubre de 2025.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-133221346 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1824703498\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Por qu\u00e9 es importante<\/strong><\/h3>\n\t<div id=\"gap-69856295\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-69856295 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n mejora la transparencia en torno a <strong>Restricciones de ingredientes de los suplementos de salud<\/strong>, Refuerza la supervisi\u00f3n de la seguridad tanto de los suplementos como de los medicamentos tradicionales, y establece expectativas regulatorias consistentes para la formulaci\u00f3n, el etiquetado y la supervisi\u00f3n de productos. Este marco m\u00e1s claro promueve un desarrollo de productos m\u00e1s seguro y procesos de cumplimiento m\u00e1s predecibles sin a\u00f1adir una carga operativa innecesaria.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1824703498 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1365042560\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>\u00bfQui\u00e9n deber\u00eda revisar esta actualizaci\u00f3n?<\/strong><\/h3>\n\t<div id=\"gap-1047051280\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1047051280 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Este desarrollo normativo es particularmente relevante para <strong>Asuntos regulatorios<\/strong>, <strong>Seguro de calidad<\/strong>, <strong>fabricantes<\/strong>, <strong>importadores<\/strong>, <strong>distribuidores<\/strong>, y los equipos de cumplimiento involucrados en <strong>suplementos de salud<\/strong>, <strong>medicinas tradicionales<\/strong>, y global <strong>evaluaciones de seguridad de productos sanitarios<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1365042560 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1433038083\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><strong>Pr\u00f3ximos pasos<\/strong><\/h3>\n\t<div id=\"gap-851697868\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-851697868 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los equipos reguladores deben evaluar las directrices actualizadas para identificar los productos afectados y determinar si se requieren actualizaciones en las formulaciones, la documentaci\u00f3n de seguridad, los sistemas de monitoreo o el etiquetado. Las empresas deben revisar <strong>Anexo B<\/strong> sustancias, realizar las acciones necesarias <strong>evaluaciones de seguridad<\/strong>, y garantizar que existan sistemas para <strong>notificaci\u00f3n de efectos adversos<\/strong> y seguimiento continuo.<\/p>\n<p>A medida que las organizaciones eval\u00faan sus carteras, esta es una oportunidad oportuna para fortalecer el monitoreo de ingredientes y agilizar los flujos de trabajo regulatorios globales. <a href=\"https:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a><strong> es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de agencia.<\/strong> que ayuda a las organizaciones a gestionar entornos regulatorios complejos en m\u00e1s de 140 pa\u00edses. Al combinar la IA avanzada de Agentic con expertos en el sector, RegASK proporciona informaci\u00f3n predictiva y pr\u00e1ctica oportuna, facilita la verificaci\u00f3n del cumplimiento normativo de los ingredientes y automatiza la supervisi\u00f3n regulatoria para acelerar el acceso al mercado global. <a href=\"https:\/\/regask.com\/es\/producto\/\"><strong>M\u00e1s informaci\u00f3n<\/strong><\/a><strong> o <\/strong><a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong>Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1433038083 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-317502035\">\n\n\t<div id=\"col-2023453384\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-1539084545\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1539084545 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u00bfQu\u00e9 sustancias est\u00e1n prohibidas seg\u00fan la regulaci\u00f3n actualizada de los suplementos de salud de la HSA?<\/h4>\n\t<div id=\"gap-366594745\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-366594745 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las sustancias prohibidas incluyen aquellas enumeradas en la <strong>Ley de venenos de 1938<\/strong>, <strong>Ley de 1973 sobre el uso indebido de drogas<\/strong>, <strong>materiales derivados del ser humano<\/strong>, y sustancias reguladas por la <strong>Ley de Especies en Peligro de Extinci\u00f3n<\/strong>, a menos que est\u00e9 expl\u00edcitamente permitido.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2023453384 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1761042010\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfCu\u00e1les son los ingredientes restringidos en las pautas de suplementos de salud de HSA?<\/h4>\n\t<div id=\"gap-1520157160\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1520157160 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los ingredientes restringidos son sustancias que solo pueden usarse en condiciones espec\u00edficas, como <strong>l\u00edmites m\u00e1ximos de dosis diaria<\/strong> o <strong>requisitos de etiquetado<\/strong>, tal como se establece en <strong>Anexo A<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1761042010 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-598933946\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfQu\u00e9 obligaciones tienen los concesionarios seg\u00fan las nuevas directrices de la HSA?<\/h4>\n\t<div id=\"gap-2096970334\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2096970334 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los distribuidores deben realizar <strong>evaluaciones de seguridad<\/strong>, informe <strong>efectos adversos<\/strong>, mantener <strong>evidencia de seguridad del producto<\/strong>, asegurar <strong>etiquetado apropiado<\/strong>, y monitorear las sustancias con posibles problemas de seguridad enumeradas en <strong>Anexo B<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-598933946 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1063719448\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>\u00bfC\u00f3mo puede RegASK ayudar a las empresas afectadas por la actualizaci\u00f3n de la regulaci\u00f3n de suplementos de salud de HSA?<\/h4>\n\t<div id=\"gap-1972965667\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1972965667 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>RegASK ayuda a las empresas a realizar un seguimiento de los cambios regulatorios, evaluar el cumplimiento de los ingredientes y automatizar el monitoreo global mediante IA agentic, lo que respalda respuestas precisas y oportunas a actualizaciones como esta revisi\u00f3n de las pautas de HSA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1063719448 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 29 de octubre de 2025, la Autoridad de Ciencias de la Salud (HSA) de Singapur public\u00f3 directrices actualizadas sobre los ingredientes prohibidos y restringidos en los suplementos para la salud y la medicina tradicional. Esta actualizaci\u00f3n refuerza la claridad regulatoria y las expectativas de seguridad para las empresas globales dedicadas a la formulaci\u00f3n, fabricaci\u00f3n y distribuci\u00f3n de suplementos para la salud.<\/p>","protected":false},"author":32,"featured_media":9195,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,583],"tags":[],"class_list":["post-9193","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-singapore-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Singapore\u2019s HSA Issues Updated Health Supplement Regulation<\/title>\n<meta name=\"description\" content=\"Stay informed about Singapore\u2019s HSA new health supplement regulation on prohibited and 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