{"id":8174,"date":"2025-04-04T03:30:11","date_gmt":"2025-04-03T19:30:11","guid":{"rendered":"https:\/\/regask.com\/?p=8174"},"modified":"2025-04-09T14:29:54","modified_gmt":"2025-04-09T06:29:54","slug":"conformite-aux-bpf-au-mexique-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/mexico-gmp-compliance-2025\/","title":{"rendered":"COFEPRIS (Mexique) publie des lignes directrices pour les documents GMP\u2026"},"content":{"rendered":"<p data-pm-slice=\"1 3 []\">Le 20 mars 2025, la Commission f\u00e9d\u00e9rale mexicaine pour la protection contre les risques sanitaires (COFEPRIS) a publi\u00e9 au Journal officiel (JO) l&#039;accord portant \u00e9mission des lignes directrices pour la soumission des documents garantissant les bonnes pratiques de fabrication (BPF) des principes actifs, des m\u00e9dicaments et des dispositifs m\u00e9dicaux. Ces lignes directrices s&#039;appliquent aux demandes de nouveaux enregistrements sanitaires, ainsi qu&#039;\u00e0 leurs extensions et modifications. La nouvelle r\u00e9glementation d\u00e9finit les exigences et les crit\u00e8res de soumission des documents BPF, visant \u00e0 optimiser la conformit\u00e9 aux normes internationales et \u00e0 renforcer la coop\u00e9ration avec les autorit\u00e9s r\u00e9glementaires reconnues.<\/p>\n<h4><strong>Points cl\u00e9s<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Les lignes directrices pr\u00e9cisent la documentation n\u00e9cessaire, y compris les certificats de bonnes pratiques de fabrication ou les documents \u00e9quivalents, requis pour les ingr\u00e9dients pharmaceutiques, les m\u00e9dicaments et les dispositifs m\u00e9dicaux dans les demandes d&#039;enregistrement sanitaire, les renouvellements et les modifications.<\/li>\n<li>L\u2019accent est mis sur le respect des normes internationales GMP pour garantir la s\u00e9curit\u00e9, l\u2019efficacit\u00e9 et la coh\u00e9rence des produits tout au long du processus de fabrication.<\/li>\n<li>Les cat\u00e9gories de produits concern\u00e9es comprennent :\n<ul data-spread=\"false\">\n<li>Ingr\u00e9dients pharmaceutiques actifs (API)<\/li>\n<li>M\u00e9dicaments en vente libre (OTC)<\/li>\n<li>M\u00e9dicaments sur ordonnance<\/li>\n<li>Divers dispositifs m\u00e9dicaux, y compris des \u00e9quipements de diagnostic et th\u00e9rapeutiques<\/li>\n<\/ul>\n<\/li>\n<li>Le r\u00e8glement favorise l\u2019alignement avec les autorit\u00e9s r\u00e9glementaires reconnues \u00e0 l\u2019\u00e9chelle mondiale, facilitant potentiellement un acc\u00e8s plus facile aux produits conformes sur les march\u00e9s internationaux.<\/li>\n<li>Les fabricants sont encourag\u00e9s \u00e0 respecter strictement ces directives afin de maintenir leur statut d\u2019enregistrement et d\u2019assurer un processus d\u2019approbation plus fluide pour les enregistrements sanitaires nouveaux ou modifi\u00e9s.<\/li>\n<\/ul>\n<h4><strong>Prochaines \u00e9tapes<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Les fabricants doivent \u00e9valuer et mettre \u00e0 jour leur documentation GMP pour l\u2019aligner sur les nouvelles directives COFEPRIS.<\/li>\n<li>Les entreprises doivent s\u2019assurer que leurs processus de production et leurs syst\u00e8mes de contr\u00f4le de la qualit\u00e9 r\u00e9pondent aux attentes r\u00e9glementaires r\u00e9vis\u00e9es.<\/li>\n<li>Un suivi \u00e9troit des mises \u00e0 jour r\u00e9glementaires et un engagement proactif avec COFEPRIS seront essentiels pour maintenir la conformit\u00e9 et rationaliser les processus d\u2019approbation.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Le 20 mars 2025, la Commission f\u00e9d\u00e9rale mexicaine pour la protection contre les risques sanitaires (COFEPRIS) a publi\u00e9 au Journal officiel (JO) l&#039;accord \u00e9tablissant les lignes directrices pour la soumission des documents garantissant les bonnes pratiques de fabrication (BPF) des principes actifs, des m\u00e9dicaments et des dispositifs m\u00e9dicaux. Ces lignes directrices s&#039;appliquent aux demandes d&#039;homologation sanitaire, ainsi qu&#039;aux\u2026<\/p>","protected":false},"author":43,"featured_media":8207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[521,35],"tags":[609],"class_list":["post-8174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico-regulations","category-pharma-biotech-latest-insights","tag-guideline"],"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>Mexico GMP 2025: Key Updates | RegASK<\/title>\n<meta name=\"description\" content=\"Stay compliant! COFEPRIS updates GMP rules in 2025. Key changes for APIs, drugs, &amp; devices.Ensure seamless compliance now.\" \/>\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\/fr\/conformite-aux-bpf-au-mexique-2025\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"COFEPRIS (Mexico) Publishes Guidelines for GMP Documentation for Active Ingredients, Medicines, and Medical Devices Submissions\" \/>\n<meta property=\"og:description\" content=\"Stay compliant! COFEPRIS updates GMP rules in 2025. Key changes for APIs, drugs, &amp; devices.Ensure seamless compliance now.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/conformite-aux-bpf-au-mexique-2025\/\" \/>\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=\"2025-04-03T19:30:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-09T06:29:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\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=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"COFEPRIS (Mexico) Publishes Guidelines for GMP Document&hellip;\",\"datePublished\":\"2025-04-03T19:30:11+00:00\",\"dateModified\":\"2025-04-09T06:29:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/\"},\"wordCount\":269,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png\",\"keywords\":[\"Guideline\"],\"articleSection\":[\"Mexico\",\"Pharma and Biotech\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/\",\"name\":\"Mexico GMP 2025: Key Updates | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png\",\"datePublished\":\"2025-04-03T19:30:11+00:00\",\"dateModified\":\"2025-04-09T06:29:54+00:00\",\"description\":\"Stay compliant! COFEPRIS updates GMP rules in 2025. Key changes for APIs, drugs, & devices.Ensure seamless compliance now.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/mexico-gmp-compliance-2025\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png\",\"width\":800,\"height\":600,\"caption\":\"Cofepris Mexico Publishes Guidelines Gmp Documentation Active Ingredients Medicines Medical Devices Submissions\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\",\"name\":\"Reva Ananda\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Mexique GMP 2025\u00a0: principales mises \u00e0 jour | RegASK","description":"Restez conforme ! COFEPRIS met \u00e0 jour les r\u00e8gles GMP en 2025. Changements cl\u00e9s pour les API, les m\u00e9dicaments et les dispositifs. Assurez une conformit\u00e9 parfaite d\u00e8s maintenant.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/conformite-aux-bpf-au-mexique-2025\/","og_locale":"fr_FR","og_type":"article","og_title":"COFEPRIS (Mexico) Publishes Guidelines for GMP Documentation for Active Ingredients, Medicines, and Medical Devices Submissions","og_description":"Stay compliant! COFEPRIS updates GMP rules in 2025. Key changes for APIs, drugs, & devices.Ensure seamless compliance now.","og_url":"https:\/\/regask.com\/fr\/conformite-aux-bpf-au-mexique-2025\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2025-04-03T19:30:11+00:00","article_modified_time":"2025-04-09T06:29:54+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png","type":"image\/png"}],"author":"Reva Ananda","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Reva Ananda","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/#article","isPartOf":{"@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/"},"author":{"name":"Reva Ananda","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926"},"headline":"COFEPRIS (Mexico) Publishes Guidelines for GMP Document&hellip;","datePublished":"2025-04-03T19:30:11+00:00","dateModified":"2025-04-09T06:29:54+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/"},"wordCount":269,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png","keywords":["Guideline"],"articleSection":["Mexico","Pharma and Biotech"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/","url":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/","name":"Mexique GMP 2025\u00a0: principales mises \u00e0 jour | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png","datePublished":"2025-04-03T19:30:11+00:00","dateModified":"2025-04-09T06:29:54+00:00","description":"Restez conforme ! COFEPRIS met \u00e0 jour les r\u00e8gles GMP en 2025. Changements cl\u00e9s pour les API, les m\u00e9dicaments et les dispositifs. Assurez une conformit\u00e9 parfaite d\u00e8s maintenant.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/mexico-gmp-compliance-2025\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/mexico-gmp-compliance-2025\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/04\/cofepris-mexico-publishes-guidelines-gmp-documentation-active-ingredients-medicines-medical-devices-submissions.png","width":800,"height":600,"caption":"Cofepris Mexico Publishes Guidelines Gmp Documentation Active Ingredients Medicines Medical Devices Submissions"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Le syst\u00e8me d&#039;exploitation d&#039;IA r\u00e9glementaire pour les \u00e9quipes performantes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926","name":"Reva Ananda"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/8174","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=8174"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/8174\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/8207"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=8174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=8174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=8174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}