{"id":11353,"date":"2026-09-29T11:27:36","date_gmt":"2026-09-29T03:27:36","guid":{"rendered":"https:\/\/regask.com\/?p=11353"},"modified":"2026-09-29T11:27:36","modified_gmt":"2026-09-29T03:27:36","slug":"sciences-de-la-vie-en-septembre-2026-trois-signes-que-les-organismes-de-reglementation-travaillent-de-concert","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/life-sciences-in-september-2026-three-signs-regulators-are-moving-together\/","title":{"rendered":"Sciences de la vie en septembre 2026\u00a0: trois signes que les organismes de r\u00e9glementation\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW255062761 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW255062761 BCX0\">Septembre 2026 a mis en lumi\u00e8re un point essentiel dans le domaine des sciences de la vie\u00a0: les organismes de r\u00e9glementation commencent \u00e0 harmoniser leurs efforts. Notre outil Trends Radar a analys\u00e9 l\u2019activit\u00e9 dans les secteurs des dispositifs m\u00e9dicaux, de la pharmacovigilance et des produits biologiques, et une m\u00eame tendance s\u2019est constamment d\u00e9gag\u00e9e. Les autorit\u00e9s de diff\u00e9rents continents\u2026 <\/span><span class=\"NormalTextRun SCXW255062761 BCX0\">alignement<\/span><span class=\"NormalTextRun SCXW255062761 BCX0\"> normes partag\u00e9es, reconnaissance des d\u00e9cisions de chacun et aboutissement \u00e0 des conclusions similaires \u00e0 <\/span><span class=\"NormalTextRun SCXW255062761 BCX0\">\u00e0 peu pr\u00e8s le<\/span><span class=\"NormalTextRun SCXW255062761 BCX0\"> Ce mois-ci, nous analysons trois tendances \u00e0 l&#039;origine de cette \u00e9volution. Premi\u00e8rement, la convergence discr\u00e8te des r\u00e9glementations relatives aux dispositifs m\u00e9dicaux et aux diagnostics in vitro (DIV) vers un socle commun. Deuxi\u00e8mement, l&#039;\u00e9ch\u00e9ance du 1er octobre fix\u00e9e par la FDA pour le d\u00e9p\u00f4t des E2B(R3) et la r\u00e9vision des BPC chinoises t\u00e9moignent d&#039;une standardisation rapide de la pharmacovigilance. Troisi\u00e8mement, la d\u00e9pendance r\u00e9glementaire acc\u00e9l\u00e8re l&#039;acc\u00e8s des produits biologiques \u00e0 de nouveaux march\u00e9s. Pour les \u00e9quipes internationales, cette convergence offre de r\u00e9elles opportunit\u00e9s, \u00e0 condition de respecter le calendrier de chaque autorit\u00e9.<\/span><\/span><span class=\"EOP Selected SCXW255062761 BCX0\" data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-1128104003\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1128104003 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW147708193 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW147708193 BCX0\" data-ccp-parastyle=\"heading 2\">Le cadre r\u00e9glementaire mondial des dispositifs m\u00e9dicaux est en train de se mettre en place discr\u00e8tement.<\/span><\/span><span class=\"EOP Selected SCXW147708193 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-1967893151\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1967893151 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-1658236323\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1658236323 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Si vous g\u00e9rez les enregistrements de dispositifs m\u00e9dicaux ou de diagnostics in vitro sur plusieurs march\u00e9s, vous \u00eates probablement habitu\u00e9 \u00e0 une disparit\u00e9 flagrante\u00a0: classifications diff\u00e9rentes, exigences de fabrication diff\u00e9rentes, r\u00e9glementations post-commercialisation diff\u00e9rentes selon les juridictions. Cette disparit\u00e9 est en train de se r\u00e9sorber. En septembre\u00a02026, notre Radar des tendances a recens\u00e9 plus de 50\u00a0d\u00e9veloppements officiels concernant les dispositifs m\u00e9dicaux et les diagnostics in vitro (le th\u00e8me le plus suivi du mois), et le plus frappant n\u2019\u00e9tait pas le nombre, mais la direction. Les autorit\u00e9s r\u00e9glementaires de diff\u00e9rents continents s\u2019orientent vers un r\u00e9f\u00e9rentiel commun.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/09\/11\/2026-18612\/medical-devices-cardiovascular-devi%E2%80%A6\"><span data-contrast=\"none\">La FDA am\u00e9ricaine<\/span><\/a><span data-contrast=\"auto\"> La Chine a finalis\u00e9 les classifications d&#039;une nouvelle g\u00e9n\u00e9ration de dispositifs, notamment un logiciel de notification cardiovasculaire bas\u00e9 sur l&#039;apprentissage automatique, signe de l&#039;importance qu&#039;elle accorde d\u00e9sormais aux produits adaptatifs pilot\u00e9s par l&#039;IA. La Chine a confirm\u00e9 sa r\u00e9vision <\/span><a href=\"https:\/\/english.nmpa.gov.cn\/2025-11\/07\/c_1138710.htm\"><span data-contrast=\"none\">Bonnes pratiques de fabrication<\/span><\/a><span data-contrast=\"auto\"> La r\u00e9glementation relative aux dispositifs m\u00e9dicaux entrera en vigueur le 1er novembre 2026. Ta\u00efwan a modifi\u00e9 sa r\u00e9glementation. <\/span><a href=\"https:\/\/www.fda.gov.tw\/tc\/newsContent.aspx?cid=3&amp;id=31726\"><span data-contrast=\"none\">r\u00e9glementation sur le rappel des dispositifs<\/span><\/a><span data-contrast=\"auto\">, et le <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/medical-devices\"><span data-contrast=\"none\">EMA<\/span><\/a><span data-contrast=\"auto\"> L&#039;institut a fait progresser son projet pilote d&#039;experts sur les dispositifs r\u00e9volutionnaires. L&#039;intelligence artificielle est omnipr\u00e9sente, tandis que les autorit\u00e9s s&#039;accordent sur la mani\u00e8re d&#039;autoriser les logiciels qui continuent d&#039;apprendre apr\u00e8s leur commercialisation.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Pour les \u00e9quipes r\u00e9glementaires, cette convergence ouvre la voie \u00e0 des exigences communes. Les attentes, autrefois tr\u00e8s divergentes (documentation technique, donn\u00e9es cliniques, syst\u00e8mes qualit\u00e9), tendent \u00e0 se rapprocher. Ainsi, le travail effectu\u00e9 pour satisfaire une autorit\u00e9 exigeante est de plus en plus transf\u00e9r\u00e9 aux autres. Cependant, convergence ne rime pas avec harmonisation\u00a0: chaque organisme r\u00e9glementaire avance \u00e0 son propre rythme, et l\u2019\u00e9ch\u00e9ance de novembre pour les BPF en Chine nous rappelle concr\u00e8tement que \u201c\u00a0alignement de principe\u00a0\u201d signifie encore \u201c\u00a0agir avant une date pr\u00e9cise\u00a0\u201d. Les \u00e9quipes qui tireront profit de cette \u00e9volution seront celles qui suivront le calendrier de chaque autorit\u00e9, et non celles qui miseront sur une transition mondiale unique.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW77488179 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW77488179 BCX0\" data-ccp-parastyle=\"heading 2\">Deux \u00e9ch\u00e9ances, une seule direction\u00a0: la pharmacovigilance se standardise rapidement<\/span><\/span><span class=\"EOP Selected SCXW77488179 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-152154952\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-152154952 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Le 1er octobre 2026 est une date \u00e0 retenir. C&#039;est \u00e0 cette date que\u2026 <\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/electronic-submission-postmarket-safety-reports\"><span data-contrast=\"none\">L&#039;agence am\u00e9ricaine des produits alimentaires et m\u00e9dicamenteux (FDA)<\/span><\/a><span data-contrast=\"auto\"> passage obligatoire au <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/fda-adverse-event-monitoring-system-aems\/fda-adverse-event-monitoring-system-aems-electronic-submissions\"><span data-contrast=\"none\">ICH E2B(R3)<\/span><\/a><span data-contrast=\"auto\"> Le format de soumission des rapports de s\u00e9curit\u00e9 post-commercialisation entre en vigueur\u00a0; fini les transitions volontaires et les anciens formats. Il intervient quelques semaines seulement apr\u00e8s la r\u00e9vision par la Chine\u2026, <\/span><a href=\"https:\/\/www.ccfdie.org\/en\/gzdt\/webinfo\/2026\/06\/1784092178460426.htm\"><span data-contrast=\"none\">Bonnes pratiques cliniques align\u00e9es sur les directives ICH<\/span><\/a><span data-contrast=\"auto\"> sont entr\u00e9es en vigueur le 1er septembre. Prises ensemble, elles t\u00e9moignent d&#039;une tendance mondiale constante vers des normes communes concernant la collecte, le formatage et l&#039;\u00e9change des donn\u00e9es sur la s\u00e9curit\u00e9 des m\u00e9dicaments.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Mais l&#039;harmonisation technique ne repr\u00e9sente que la moiti\u00e9 de l&#039;histoire que notre Radar des tendances a relev\u00e9e ce mois-ci. L&#039;autre moiti\u00e9 concerne la convergence scientifique sur les signaux de s\u00e9curit\u00e9 eux-m\u00eames (les autorit\u00e9s parvenant de plus en plus souvent aux m\u00eames conclusions en mati\u00e8re d&#039;\u00e9tiquetage et de risques, et ce, quasiment au m\u00eame moment), dans un contexte exceptionnellement charg\u00e9 de rappels de produits et d&#039;alertes de s\u00e9curit\u00e9 en Afrique subsaharienne, en Am\u00e9rique latine et au Moyen-Orient. L&#039;activit\u00e9 de pharmacovigilance a concern\u00e9 l&#039;ensemble des neuf r\u00e9gions que nous suivons, soit la couverture g\u00e9ographique la plus \u00e9tendue de tous les th\u00e8mes li\u00e9s aux sciences de la vie.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Pour toute personne en charge de la s\u00e9curit\u00e9 \u00e0 l&#039;\u00e9chelle mondiale, deux enseignements pratiques se d\u00e9gagent. Le premier, \u00e0 court terme, est op\u00e9rationnel\u00a0: si vos syst\u00e8mes ne le sont pas\u2026 <\/span><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/electronic-submission-postmarket-safety-reports\"><span data-contrast=\"none\">E2B(R3)<\/span><\/a><span data-contrast=\"auto\">L&#039;\u00e9ch\u00e9ance fix\u00e9e par la FDA est imminente. \u00c0 plus long terme, l&#039;enjeu est strat\u00e9gique\u00a0: face \u00e0 la convergence des autorit\u00e9s, un signal de s\u00e9curit\u00e9 apparu sur un march\u00e9 est devenu un indicateur fiable des mesures r\u00e9glementaires \u00e0 prendre sur d&#039;autres march\u00e9s. Consid\u00e9rer chaque alerte nationale comme un \u00e9v\u00e9nement isol\u00e9 revient \u00e0 sous-estimer l&#039;interd\u00e9pendance de ces d\u00e9cisions. L&#039;avantage concurrentiel r\u00e9side dans la capacit\u00e9 \u00e0 interpr\u00e9ter le premier signal comme un avertissement pr\u00e9coce pour l&#039;ensemble des march\u00e9s de votre portefeuille.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW193139655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW193139655 BCX0\" data-ccp-parastyle=\"heading 2\">Reliance red\u00e9finit la mani\u00e8re dont les produits biologiques atteignent de nouveaux march\u00e9s.<\/span><\/span><span class=\"EOP Selected SCXW193139655 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/strong><\/h3>\n\t<div id=\"gap-1066537312\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1066537312 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Pendant des d\u00e9cennies, l&#039;introduction d&#039;un produit biologique ou d&#039;un vaccin dans un nouveau pays impliquait une seule chose\u00a0: un nouvel examen r\u00e9glementaire complet, reproduisant en grande partie le travail d\u00e9j\u00e0 effectu\u00e9 ailleurs. Ce mod\u00e8le est en train de dispara\u00eetre, et septembre\u00a02026 en a fourni un exemple frappant. <\/span><a href=\"https:\/\/sidof.segob.gob.mx\/notas\/docFuente\/5797710\"><span data-contrast=\"none\">COFEPRIS du Mexique<\/span><\/a><span data-contrast=\"auto\"> a cr\u00e9\u00e9 une proc\u00e9dure d&#039;autorisation de mise sur le march\u00e9 abr\u00e9g\u00e9e qui reconna\u00eet formellement les approbations de l&#039;ANVISA du Br\u00e9sil, un exemple concret de d\u00e9pendance r\u00e9glementaire, o\u00f9 une d\u00e9cision de r\u00e9f\u00e9rence fiable se substitue \u00e0 une \u00e9valuation ind\u00e9pendante compl\u00e8te.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Ce ph\u00e9nom\u00e8ne n&#039;est pas isol\u00e9. Notre outil de veille des tendances a recens\u00e9 pr\u00e8s de 20 d\u00e9veloppements dans les domaines des produits biologiques, des vaccins et des th\u00e9rapies innovantes ce mois-ci, dont beaucoup concernent les march\u00e9s \u00e9mergents. <\/span><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-atualiza-vacina-da-covid-e-lista-de-medicamentos-de-baixo-risco\"><span data-contrast=\"none\">ANVISA<\/span><\/a><span data-contrast=\"auto\"> Singapour a mis \u00e0 jour ses propres listes de vaccins contre la COVID-19 et de m\u00e9dicaments \u00e0 faible risque\u00a0; la ville a adopt\u00e9 une loi consolidant ces listes. <\/span><a href=\"https:\/\/www.hsa.gov.sg\/announcements\"><span data-contrast=\"none\">fonctions de r\u00e9gulation de la sant\u00e9<\/span><\/a><span data-contrast=\"auto\"> en vertu de la loi HSA, rationalisation de la surveillance; et le <\/span><a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/06\/24\/2026-12622\/demonstrating-substantial-evidence-%E2%80%A6\"><span data-contrast=\"none\">La FDA<\/span><\/a><span data-contrast=\"auto\"> Des lignes directrices r\u00e9vis\u00e9es et avanc\u00e9es ont \u00e9t\u00e9 \u00e9labor\u00e9es concernant la d\u00e9monstration de preuves substantielles d&#039;efficacit\u00e9 pour les m\u00e9dicaments et les produits biologiques. Le point commun est l&#039;acc\u00e8s aux m\u00e9dicaments\u00a0: les autorit\u00e9s mettent en place des proc\u00e9dures d&#039;autorisation plus rapides et plus simples, plut\u00f4t que de r\u00e9inventer la roue \u00e0 chaque fois.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">L&#039;opportunit\u00e9 pour les entreprises est r\u00e9elle, mais conditionnelle. Un dossier solide sur un march\u00e9 de r\u00e9f\u00e9rence reconnu constitue d\u00e9sormais un atout pr\u00e9cieux, susceptible de r\u00e9duire consid\u00e9rablement les d\u00e9lais d&#039;approbation dans les juridictions adoptant ce cadre r\u00e9glementaire. Le hic\u00a0? Chaque cadre r\u00e9glementaire poss\u00e8de sa propre liste d&#039;autorit\u00e9s reconnues, de types de produits \u00e9ligibles et de r\u00e8gles de documentation. Savoir pr\u00e9cis\u00e9ment quelles approbations sont valides et o\u00f9 elles le sont devient un \u00e9l\u00e9ment central de la strat\u00e9gie de lancement mondial, et non plus une simple formalit\u00e9 r\u00e9glementaire.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>September 2026 made one thing clear across life sciences: regulators are starting to move in step. Our Trends Radar tracked activity across devices, drug safety and biologics, and the same pattern kept showing up. Authorities on different continents are aligning shared standards, recognizing each other&#8217;s decisions, and reaching similar conclusions at roughly the same time&#8230;.<\/p>","protected":false},"author":46,"featured_media":9717,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-11353","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Life Sciences in September 2026: Key Regulatory Changes<\/title>\n<meta name=\"description\" content=\"Explore signs of harmonization in Life Sciences in September 2026 as regulators align standards across continents.\" \/>\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\/sciences-de-la-vie-en-septembre-2026-trois-signes-que-les-organismes-de-reglementation-travaillent-de-concert\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Life Sciences in September 2026: Three Signs Regulators Are Moving Together\" \/>\n<meta property=\"og:description\" content=\"Explore signs of harmonization in Life Sciences in September 2026 as regulators align standards across continents.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/sciences-de-la-vie-en-septembre-2026-trois-signes-que-les-organismes-de-reglementation-travaillent-de-concert\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta 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