{"id":5404,"date":"2022-03-17T14:27:19","date_gmt":"2022-03-17T18:27:19","guid":{"rendered":"https:\/\/spharm-inc.com\/wp2021\/?p=5404"},"modified":"2023-01-25T18:23:49","modified_gmt":"2023-01-25T23:23:49","slug":"comment-le-processus-de-demande-du-canada-se-compare-t-il-a-celui-des-e-u-et-de-lue","status":"publish","type":"post","link":"https:\/\/spharm-inc.com\/fr\/comment-le-processus-de-demande-du-canada-se-compare-t-il-a-celui-des-e-u-et-de-lue\/","title":{"rendered":"Comment le processus de demande du Canada se compare-t-il \u00e0 celui des \u00c9.-U. et de l\u2019UE?"},"content":{"rendered":"\t\t
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Comment le processus de demande du Canada se compare-t-il \u00e0 celui des \u00c9.-U. et de l\u2019UE?<\/h1>

COMMENT LE PROCESSUS DE DEMANDE D\u2019ESSAI CLINIQUE DE SANT\u00c9 CANADA SE COMPARE-T-IL \u00c0 CELUI DES \u00c9TATS-UNIS?<\/strong><\/span><\/p>

Lorsque le processus est bien compris et que le promoteur ou les repr\u00e9sentants ont \u00e9tabli des contacts avec Sant\u00e9 Canada, soumettre une demande d\u2019essai clinique au Canada est relativement simple, tout comme le processus d\u2019examen. La structure de soumission proprement dite est \u00e9galement simple et les exigences en mati\u00e8re de contenu sont en r\u00e9alit\u00e9 moindres qu\u2019aux \u00c9tats-Unis ou en Europe.<\/p>

Aucun rapport d\u2019\u00e9tude clinique ou non-clinique n\u2019est requis dans la demande d\u2019essai clinique. Ce qu\u2019il faut, ce sont les documents administratifs et les documents scientifiques cl\u00e9s, \u00e0 savoir le protocole, le formulaire de consentement \u00e9clair\u00e9 et la brochure de l\u2019investigateur. Il faut aussi g\u00e9n\u00e9rer deux documents sp\u00e9cifiques au Canada: le r\u00e9sum\u00e9 du protocole et le Document certifi\u00e9 d\u2019information sur le produit. Tout cela est assez facile \u00e0 pr\u00e9parer.<\/p>

Le processus de r\u00e9vision est \u00e9galement efficace. Une p\u00e9riode de r\u00e9vision par d\u00e9faut de 30 jours s\u2019applique. Si des questions sont soulev\u00e9es pendant l\u2019examen du dossier, une r\u00e9ponse doit \u00eatre fournie dans les deux jours civils (des exceptions peuvent s\u2019appliquer). \u00c0 titre de comparaison, au Canada, il n\u2019y a pas de p\u00e9riode d\u2019attente clinique comme aux \u00c9tats-Unis. La p\u00e9riode de r\u00e9vision est toujours de 30 jours, alors que dans certains pays europ\u00e9ens, la p\u00e9riode de r\u00e9vision peut aller jusqu\u2019\u00e0 60 jours ou plus, et aux \u00c9tats-Unis elle peut varier.<\/p>

La p\u00e9riode d\u2019examen standard de 30 jours au Canada facilite la demande d\u2019\u00e9valuation aux comit\u00e9s d\u2019\u00e9thique, acc\u00e9l\u00e9rant ainsi le lancement des essais cliniques. De plus, il existe au Canada des experts en d\u00e9marrage d\u2019essais cliniques efficaces qui contribuent \u00e0 optimiser le processus de d\u00e9marrage de l\u2019\u00e9tude parall\u00e8lement ou apr\u00e8s l\u2019approbation de la demande d\u2019essai clinique.<\/p>

Les politiques et lignes directrices de Sant\u00e9 Canada en mati\u00e8re de s\u00e9curit\u00e9 sont-elles plus strictes que celles impos\u00e9es par la FDA?<\/strong><\/p>

Les exigences sont semblables au Canada et aux \u00c9tats-Unis pour les demandes d\u2019essais cliniques ainsi que pour les modifications ou initiatives post-approbation.

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\u00a0<\/strong><\/p>

Pour toute question sur le processus canadien d\u2019examen et de r\u00e9glementation des m\u00e9dicaments qui n\u2019est pas couverte dans cette section, n\u2019h\u00e9sitez pas \u00e0 communiquer directement avec nous<\/a>.<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Comment le processus de demande du Canada se compare-t-il \u00e0 celui des \u00c9.-U. et de l\u2019UE? COMMENT LE PROCESSUS DE DEMANDE D\u2019ESSAI CLINIQUE DE SANT\u00c9 CANADA SE COMPARE-T-IL \u00c0 CELUI DES \u00c9TATS-UNIS? Lorsque le processus est bien compris et que le promoteur ou les repr\u00e9sentants ont \u00e9tabli des contacts avec Sant\u00e9 Canada, soumettre une demande […]<\/p>\n","protected":false},"author":3,"featured_media":6564,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"class_list":["post-5404","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nComment le processus de demande du Canada se compare?<\/title>\n<meta name=\"description\" content=\"Analyse comparative d\u00e9taill\u00e9e entre les processus r\u00e9glementaires du Canada, des \u00c9tats-Unis et de l\u2019Union europ\u00e9enne.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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