{"id":27491,"date":"2020-11-16T10:08:30","date_gmt":"2020-11-16T09:08:30","guid":{"rendered":"https:\/\/kymos.com\/news\/tests-par-lots-et-mise-en-circulation-la-vie-apres-le-brexit\/"},"modified":"2025-12-03T19:00:39","modified_gmt":"2025-12-03T18:00:39","slug":"tests-par-lots-et-mise-en-circulation-la-vie-apres-le-brexit","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/tests-par-lots-et-mise-en-circulation-la-vie-apres-le-brexit\/","title":{"rendered":"Tests par lots et mise en circulation : la vie apr\u00e8s le Brexit"},"content":{"rendered":"

Chez KYMOS<\/a> et ASPHALION,<\/a> nous sommes partenaires de longue date dans la fourniture de services analytiques et r\u00e9glementaires aux secteurs pharmaceutique et biotechnologique internationaux. Notre exp\u00e9rience d\u00e9passe le cadre classique des CRO travaillant avec des clients britanniques<\/em> pour surmonter les obstacles \u00e0 l’internationalisation. Nos services respectifs s’inscrivent dans une cha\u00eene d’approvisionnement internationale complexe, ce qui rend les effets du Brexit plus visibles et quantifiables. Le contr\u00f4le qualit\u00e9 (CQ) est l’un des d\u00e9partements les plus interdisciplinaires de KYMOS, avec une forte demande de la part de clients internationaux, notamment pour les tests de lots et la lib\u00e9ration des m\u00e9dicaments et des produits exp\u00e9rimentaux (IMP) au niveau de l’UE. Les caract\u00e9ristiques intrins\u00e8ques de ces services en font un excellent indicateur non tarifaire de la conjoncture actuelle du march\u00e9. <\/span><\/p>\n

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Le Brexit a entra\u00een\u00e9 d’importants changements dans l’autorisation des m\u00e9dicaments au Royaume-Uni. Imm\u00e9diatement apr\u00e8s le 31 janvier (jour du Brexit), une p\u00e9riode de transition<\/a><\/strong> a \u00e9t\u00e9 instaur\u00e9e avec l’UE afin de permettre aux deux parties de s’entendre sur les nouvelles modalit\u00e9s. Cette p\u00e9riode de transition s’est prolong\u00e9e jusqu’au 31 d\u00e9cembre 2020<\/g> , date \u00e0 laquelle la nouvelle relation UE-Royaume-Uni a d\u00e9but\u00e9, le d\u00e9lai pour prolonger la p\u00e9riode de transition \u00e9tant d\u00e9sormais expir\u00e9. \u00c0 compter du 1er janvier 2021<\/u> , la Medicines and Healthcare products Regulatory Agency (MHRA) est devenue l’autorit\u00e9 de r\u00e9glementation autonome des m\u00e9dicaments et des dispositifs m\u00e9dicaux au Royaume-Uni et a constitu\u00e9 le seul obstacle aux demandes d’autorisation pour les essais cliniques, l’importation et l’exportation, les licences et autres activit\u00e9s. <\/span><\/p>\n

Lors de la lib\u00e9ration de lots, il est crucial de disposer d’un processus de transfert de m\u00e9thodes bien \u00e9tabli, car tout retard peut compromettre les stocks de produits pharmaceutiques \u00e0 travers le monde. Llu\u00eds Racionero, directeur du contr\u00f4le qualit\u00e9, a travaill\u00e9 au sein du d\u00e9partement D\u00e9veloppement\/Validation de KYMOS avant de prendre la direction du contr\u00f4le qualit\u00e9. Son expertise couvre donc chaque \u00e9tape du processus, du d\u00e9veloppement des m\u00e9thodes \u00e0 la validation, en passant par le transfert et l’analyse des \u00e9chantillons. La demande de services de contr\u00f4le et de lib\u00e9ration de lots (T&R) a quintupl\u00e9 ces deux derni\u00e8res ann\u00e9es, probablement en raison d’un manque de confiance dans les mesures prises par le gouvernement britannique apr\u00e8s le Brexit. <\/span><\/p>\n

De plus, la plupart des clients de KYMOS au Royaume-Uni pour les essais et la validation de lots (Batch T&R) fabriquent leurs m\u00e9dicaments hors du Royaume-Uni. Ils peuvent donc chercher \u00e0 assurer la continuit\u00e9 de leurs projets et \u00e0 minimiser les risques en faisant appel \u00e0 des CRO et \u00e0 des personnes qualifi\u00e9es (PQ) bas\u00e9es en Europe continentale. Par ailleurs, KYMOS n’a pas activement promu ses services de Batch T&R, ce qui indique que la hausse de la demande est spontan\u00e9e et probablement li\u00e9e aux nouvelles exigences r\u00e9glementaires entre le Royaume-Uni et l’UE apr\u00e8s le Brexit. <\/span><\/p>\n

KYMOS est une CRO certifi\u00e9e BPF et BPL, r\u00e9guli\u00e8rement inspect\u00e9e par l’EMA et la FDA. Les clients qui collaborent avec KYMOS ont l’assurance de b\u00e9n\u00e9ficier d’un partenaire \u00e0 chaque \u00e9tape du processus, pour une large gamme de produits, des poudres aux solutions injectables, analys\u00e9s gr\u00e2ce \u00e0 un vaste \u00e9ventail de techniques. Les normes de qualit\u00e9 \u00e9lev\u00e9es de KYMOS sont appliqu\u00e9es \u00e0 chaque projet, avec une am\u00e9lioration continue de l’int\u00e9gration et de la compilation des donn\u00e9es. Nos clients savent qu’ils peuvent compter non seulement sur la qualit\u00e9 de notre travail, mais aussi sur notre flexibilit\u00e9. En cas d’urgence, nous mettons tout en \u0153uvre pour nous adapter \u00e0 leurs besoins. <\/span><\/p>\n

Nos partenaires d’ASPHALION nous apportent leur expertise gr\u00e2ce \u00e0 leur vaste exp\u00e9rience en mati\u00e8re de conseil r\u00e9glementaire. Ils estiment que le Brexit entra\u00eenera le transfert des activit\u00e9s de fabrication, de qualification des personnes qualifi\u00e9es (QP) et de lib\u00e9ration des lots au Royaume-Uni vers l’Europe continentale afin de garantir l’approbation de l’UE apr\u00e8s la p\u00e9riode de transition. Cette ann\u00e9e, ASPHALION a accompagn\u00e9 plusieurs entreprises pharmaceutiques dans l’adaptation de leurs infrastructures et proc\u00e9dures aux nouvelles l\u00e9gislations attendues, d\u00e9finies par les lignes directrices de la MHRA publi\u00e9es le 1er septembre 2020 concernant les d\u00e9marches \u00e0 suivre \u00e0 compter du 1er janvier 2021 pour la commercialisation des m\u00e9dicaments au Royaume-Uni. Bien que certaines incertitudes subsistent quant \u00e0 ces lignes directrices, ASPHALION recommande vivement, pendant la p\u00e9riode de transition, de suivre les recommandations de la MHRA et de solliciter l’avis de consultants en affaires r\u00e9glementaires au Royaume-Uni et dans l’UE. C’est pourquoi ASPHALION a ouvert un nouveau bureau au c\u0153ur de Londres en 2020 afin de proposer ses services aux clients ayant des activit\u00e9s en cours ou pr\u00e9vues au Royaume-Uni, l’un des march\u00e9s les plus importants d’Europe. Ce bureau londonien vient s’ajouter \u00e0 la liste croissante des implantations d’ASPHALION, qui comprennent d\u00e9j\u00e0 l’Espagne, l’Allemagne et les Pays-Bas. <\/span><\/p>\n

Si les hypoth\u00e8ses concernant les tendances actuelles hors du Royaume-Uni se confirment, la hausse des activit\u00e9s de contr\u00f4le et de lib\u00e9ration des lots devrait se maintenir pendant la transition de 2020 et au-del\u00e0. Les entreprises ayant entrepris les d\u00e9marches complexes li\u00e9es au passage \u00e0 un CRO continental, notamment le transfert et la validation des m\u00e9thodes ainsi que la s\u00e9lection du prestataire, pourraient exiger des garanties importantes pour un retour en arri\u00e8re. Le partenariat KYMOS-ASPHALION offre \u00e0 ses clients des services de conseil r\u00e9glementaire performants et des services de contr\u00f4le et de lib\u00e9ration des lots de la plus haute qualit\u00e9. <\/span><\/p>\n

ASPHALION peut vous accompagner dans les d\u00e9marches r\u00e9glementaires li\u00e9es au Brexit, notamment en tant que titulaire d&#39;autorisation de mise sur le march\u00e9 (AMM) bas\u00e9 au Royaume-Uni et interlocuteur local aupr\u00e8s de la MHRA. ASPHALION propose \u00e9galement des services tels que le r\u00e9tablissement de votre statut de PME ; la d\u00e9signation de m\u00e9dicament orphelin (UK PIP et YK Orphan), la d\u00e9signation de personne responsable pour l&#39;importation (RP-I) ; la pharmacovigilance (en tant que QPPV britannique) ; et la soumission \u00e9lectronique (publication et soumission via le portail britannique), ainsi que la d\u00e9finition des valeurs de r\u00e9f\u00e9rence pour les produits centralis\u00e9s b\u00e9n\u00e9ficiant de droits acquis. Pour plus d&#39;informations, veuillez contacter info@asphalion.com<\/a> . <\/em><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27492,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[],"class_list":["post-27491","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nTests par lots et mise en march\u00e9\u00a0: la vie apr\u00e8s le Brexit - Kymos<\/title>\n<meta name=\"description\" content=\"Tests et lib\u00e9ration des lots\u00a0: L\u2019apr\u00e8s-Brexit \u2013 Kymos est un importateur et fabricant certifi\u00e9 (titulaire d\u2019une licence MIA). 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Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.\",\"url\":\"https:\\\/\\\/kymos.com\\\/fr\\\/news\\\/author\\\/joan-puig-de-dou\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Tests par lots et mise en march\u00e9\u00a0: la vie apr\u00e8s le Brexit - Kymos","description":"Tests et lib\u00e9ration des lots\u00a0: L\u2019apr\u00e8s-Brexit \u2013 Kymos est un importateur et fabricant certifi\u00e9 (titulaire d\u2019une licence MIA). 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Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.","url":"https:\/\/kymos.com\/fr\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27491","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/comments?post=27491"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27491\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media\/27492"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media?parent=27491"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/categories?post=27491"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/tags?post=27491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}