{"id":4013,"date":"2022-11-23T09:11:33","date_gmt":"2022-11-23T01:11:33","guid":{"rendered":"https:\/\/regask.com\/?p=4013"},"modified":"2024-10-26T03:03:37","modified_gmt":"2024-10-25T19:03:37","slug":"normas-para-ensayos-clinicos-de-medicamentos-en-india","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/india-drug-clinical-trial-rules\/","title":{"rendered":"India propone enmiendas a la nueva normativa sobre medicamentos y ensayos cl\u00ednicos"},"content":{"rendered":"<div>\n<p><a href=\"https:\/\/main.mohfw.gov.in\/\" target=\"_blank\" rel=\"noopener\">Ministerio de Salud y Bienestar Familiar de la India (MoHFW)<\/a> propuso una enmienda a las Reglas sobre nuevos medicamentos y ensayos cl\u00ednicos (tercera enmienda), 2022 con respecto a los formularios de registro de nuevos medicamentos, nuevas API, ensayos cl\u00ednicos y estudios de biodisponibilidad\/bioequivalencia relacionados con la Autoridad Central de Licencias.<\/p>\n<p>Esta enmienda muestra los siguientes formularios y sus respectivas instrucciones:<\/p>\n<ul>\n<li>\u2026<\/li>\n<\/ul>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-1991290918\" >\n    <div class=\"slider slider-nav-circle slider-nav-large slider-nav-dark slider-style-normal\"\n        data-flickity-options='{            \"cellAlign\": \"center\",            \"imagesLoaded\": true,            \"lazyLoad\": 1,            \"freeScroll\": false,            \"wrapAround\": true,            \"autoPlay\": 4500,            \"pauseAutoPlayOnHover\" : true,            \"prevNextButtons\": true,            \"contain\" : true,            \"adaptiveHeight\" : true,            \"dragThreshold\" : 10,            \"percentPosition\": true,            \"pageDots\": false,            \"rightToLeft\": false,            \"draggable\": true,            \"selectedAttraction\": 0.1,            \"parallax\" : 0,            \"friction\": 0.6        }'\n        >\n        \n     <\/div>\n\n     <div class=\"loading-spin dark large centered\"><\/div>\n\n\t<\/div>\n\n\n\t<div id=\"gap-2098440552\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2098440552 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_1437862737\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-548800565\">\n\n\t<div id=\"col-1015549795\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_1171238322\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-168041336\">\n\n\n\t<div id=\"col-1923152479\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>Lo sentimos, este contenido premium es solo para clientes de RegASK.<\/h2>\n<p>\u00bfQuieres acceder a todo el contenido de la alerta o navegar por todas las noticias?\u00a0<\/p>\n<div class=\"row\"  id=\"row-897228553\">\n\n\n\t<div id=\"col-913271931\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Inicio de sesi\u00f3n del cliente<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/solicitar-una-demostracion\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/es\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Navegar por las noticias<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1171238322 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1437862737 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-2008629463\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2008629463 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>El Ministerio de Salud y Bienestar Familiar de la India (MoHFW) propuso una enmienda a las Normas de Nuevos Medicamentos y Ensayos Cl\u00ednicos (Tercera Enmienda) de 2022, en relaci\u00f3n con los formularios de registro de nuevos medicamentos, nuevos API, ensayos cl\u00ednicos y estudios de biodisponibilidad\/bioequivalencia, relacionados con la Autoridad Central de Licencias. Esta enmienda incluye los siguientes formularios y sus respectivas instrucciones:<\/p>","protected":false},"author":39,"featured_media":3995,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[516,35],"tags":[40,56],"class_list":["post-4013","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-india-regulations","category-pharma-biotech-latest-insights","tag-latest-insights","tag-premium-news"],"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>India: Drug &amp; Clinical Trial Rules | RegASK<\/title>\n<meta name=\"description\" content=\"India proposes amendments to its New Drugs and Clinical Trials Rules. 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Stay updated on the latest regulations with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/normas-para-ensayos-clinicos-de-medicamentos-en-india\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-11-23T01:11:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-25T19:03:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2022\/11\/India-Proposed-Amendment-to-New-Drugs-and-Clinical-Trials-Rules.png\" \/>\n\t<meta property=\"og:image:width\" content=\"330\" \/>\n\t<meta property=\"og:image:height\" content=\"300\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"India Proposed Amendment to New Drugs and Clinical Tria&hellip;\",\"datePublished\":\"2022-11-23T01:11:33+00:00\",\"dateModified\":\"2024-10-25T19:03:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/\"},\"wordCount\":88,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/India-Proposed-Amendment-to-New-Drugs-and-Clinical-Trials-Rules.png\",\"keywords\":[\"Latest Insights\",\"Premium News\"],\"articleSection\":[\"India\",\"Pharma and Biotech\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/\",\"name\":\"India: Drug & Clinical Trial Rules | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/india-drug-clinical-trial-rules\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/India-Proposed-Amendment-to-New-Drugs-and-Clinical-Trials-Rules.png\",\"datePublished\":\"2022-11-23T01:11:33+00:00\",\"dateModified\":\"2024-10-25T19:03:37+00:00\",\"description\":\"India proposes amendments to its New Drugs and Clinical Trials Rules. 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