{"id":417,"date":"2023-08-25T13:59:15","date_gmt":"2023-08-25T05:59:15","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=417"},"modified":"2024-01-18T09:57:21","modified_gmt":"2024-01-18T01:57:21","slug":"nmpa-announcement-on-adopting-ich-guidelines-m10-qas-and-faqs","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/fr\/nmpa-announcement-on-adopting-ich-guidelines-m10-qas-and-faqs\/","title":{"rendered":"Annonce des NMPA sur l'adoption des lignes directrices M10 de l'ICH - questions et r\u00e9ponses et FAQ"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">\u00a0 \u00a0 \u00a0 Afin d'aligner les normes techniques d'enregistrement des m\u00e9dicaments sur les normes internationales, l'APMN a d\u00e9cid\u00e9, apr\u00e8s d\u00e9lib\u00e9ration, d'adopter les lignes directrices M10 de l'ICH (Conseil international d'harmonisation des exigences techniques relatives aux produits pharmaceutiques \u00e0 usage humain) : Validation de la m\u00e9thode bioanalytique et analyse de l'\u00e9chantillon d'\u00e9tude (ci-apr\u00e8s d\u00e9nomm\u00e9es M10), ainsi que les documents de questions et r\u00e9ponses et les documents de questions et r\u00e9ponses. Les \u00e9l\u00e9ments pertinents sont annonc\u00e9s comme suit :<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">1. Les \u00e9tudes pertinentes \u00e0 partir du 29 juillet 2023 (sur la base de la date d'enregistrement originale de l'analyse de l'\u00e9chantillon biologique) s'appliquent aux documents M10 Q&amp;R et aux documents FAQ.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">2. Les lignes directrices techniques pertinentes peuvent \u00eatre consult\u00e9es sur le site web du Centre d'\u00e9valuation des m\u00e9dicaments de l'APMN. Le CDE de l'APNM fournira des conseils techniques en rapport avec la mise en \u0153uvre de la pr\u00e9sente annonce.<\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">L'administration nationale des produits m\u00e9dicaux<\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14pt;\">29 juin 2023<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&#038;As documents and FAQs documents. The relevant items are hereby announced as follows:<\/p>","protected":false},"author":4,"featured_media":418,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[70],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts\/417"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/comments?post=417"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/posts\/417\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/media\/418"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/media?parent=417"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/categories?post=417"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/fr\/wp-json\/wp\/v2\/tags?post=417"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}