{"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":"regeln-fur-klinische-arzneimittelstudien-in-indien","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/india-drug-clinical-trial-rules\/","title":{"rendered":"Indien schl\u00e4gt \u00c4nderung der Vorschriften f\u00fcr neue Arzneimittel und klinische Studien vor \u2026"},"content":{"rendered":"<div>\n<p><a href=\"https:\/\/main.mohfw.gov.in\/\" target=\"_blank\" rel=\"noopener\">Das indische Ministerium f\u00fcr Gesundheit und Familienf\u00fcrsorge (MoHFW)<\/a> schlug eine \u00c4nderung der Regeln f\u00fcr neue Arzneimittel und klinische Studien (dritte \u00c4nderung) 2022 in Bezug auf Registrierungsformulare f\u00fcr neue Arzneimittel, neue APIs, klinische Studien und Bioverf\u00fcgbarkeits-\/Bio\u00e4quivalenzstudien in Bezug auf die zentrale Zulassungsbeh\u00f6rde vor.<\/p>\n<p>Dieser \u00c4nderungsantrag enth\u00e4lt die folgenden Formulare und die dazugeh\u00f6rigen Anweisungen:<\/p>\n<ul>\n<li>\u2026<\/li>\n<\/ul>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-66974106\" >\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-1638482024\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1638482024 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_1012253321\">\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-1706818845\">\n\n\t<div id=\"col-89754757\" 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_669694215\">\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-1340075822\">\n\n\n\t<div id=\"col-1548106273\" 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>Entschuldigung, dieser Premium-Inhalt ist nur f\u00fcr RegASK-Kunden.<\/h2>\n<p>M\u00f6chten Sie auf den gesamten Inhalt der Warnung zugreifen oder alle Nachrichten durchsuchen?\u00a0<\/p>\n<div class=\"row\"  id=\"row-1531733881\">\n\n\n\t<div id=\"col-1328967311\" 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>Kunden-Login<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/demo-anfordern\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Demo buchen<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Durchsuchen Sie die Nachrichten<\/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_669694215 {\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_1012253321 {\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-94299820\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-94299820 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>The India Ministry of Health and Family Welfare (MoHFW) proposed an amendment to New Drugs and Clinical Trials (Third Amendment) Rules, 2022 regarding new drugs, new APIs, clinical trials, and bioavailability\/bioequivalence studies registration forms relating to Central Licensing Authority. This amendment shows the following forms and their respective instructions: \u2026<\/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 v27.5) - 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. Stay updated on the latest regulations with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/regeln-fur-klinische-arzneimittelstudien-in-indien\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"India Proposed Amendment to New Drugs and Clinical Trials Rules\" \/>\n<meta property=\"og:description\" content=\"India proposes amendments to its New Drugs and Clinical Trials Rules. Stay updated on the latest regulations with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/regeln-fur-klinische-arzneimittelstudien-in-indien\/\" \/>\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\u00a0Minute\" \/>\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\":\"de\"},{\"@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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