{"id":17818,"date":"2024-11-14T10:59:27","date_gmt":"2024-11-14T09:59:27","guid":{"rendered":"https:\/\/biokteca.com\/necesidad-de-evaluacion-regulatoria-en-las-inversiones-biotecnologicas\/"},"modified":"2025-03-05T10:24:04","modified_gmt":"2025-03-05T09:24:04","slug":"necessite-devaluation-reglementaire-dans-les-investissements-biotechnologiques","status":"publish","type":"post","link":"https:\/\/biokteca.com\/fr\/necessite-devaluation-reglementaire-dans-les-investissements-biotechnologiques\/","title":{"rendered":"N\u00e9cessit\u00e9 d\u2019\u00e9valuation r\u00e9glementaire dans les investissements biotechnologiques"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"17818\" class=\"elementor elementor-17818 elementor-36\">\n\t\t\t\t<div class=\"elementor-element elementor-element-723530b e-flex e-con-boxed e-con e-parent\" data-id=\"723530b\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d8b387 elementor-widget elementor-widget-wcf--blog--post--title\" data-id=\"1d8b387\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;data-duration&quot;:0.75,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"wcf--blog--post--title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"wcf--title\">N\u00e9cessit\u00e9 d\u2019\u00e9valuation r\u00e9glementaire dans les investissements biotechnologiques<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d15deb7 e-con-full e-flex e-con e-child\" data-id=\"d15deb7\" data-element_type=\"container\" 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fill=\"#8DCF9B\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b383f2b elementor-widget elementor-widget-wcf--blog--post--meta-info\" data-id=\"b383f2b\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--blog--post--meta-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <ul class=\"wcf--meta-list style-2\">\r\n\t        \t\t\t\r\n\t\t\t                <li class=\"wcf--author-wrap\">\r\n                    <div class=\"wcf-author-img\">\r\n                        <img alt='' src='https:\/\/biokteca.com\/wp-content\/litespeed\/avatar\/814c0006a0d8e6d8dd0edcee7ec5ccff.jpg?ver=1776177320' class='avatar avatar-55 photo' height='55' width='55' \/>                    <\/div>\r\n                    <div class=\"wcf--author-info\">\r\n                        <div class=\"wcf--author-title label\">\r\n\t\t                    R\u00e9dig\u00e9 par                        <\/div>\r\n                        <div class=\"wcf--meta-author\">\r\n                            <a href=\"https:\/\/biokteca.com\/fr\/author\/andrea-romero\/\">Andrea Romero<\/a>\r\n                        <\/div>\r\n                    <\/div>\r\n                <\/li>\r\n\t\t\t\t\t        <\/ul>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28e028e e-con-full e-flex e-con e-child\" data-id=\"28e028e\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f46d52d elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"f46d52d\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"50\" height=\"50\" viewBox=\"0 0 50 50\" fill=\"none\"><rect opacity=\"0.1\" width=\"50\" height=\"50\" rx=\"25\" fill=\"#8DCF9B\"><\/rect><path d=\"M30.8333 16.6667H30V15.8333C30 15.3733 29.6275 15 29.1667 15C28.7058 15 28.3333 15.3733 28.3333 15.8333V16.6667H21.6667V15.8333C21.6667 15.3733 21.2942 15 20.8333 15C20.3725 15 20 15.3733 20 15.8333V16.6667H19.1667C16.8692 16.6667 15 18.5358 15 20.8333V30.8333C15 33.1308 16.8692 35 19.1667 35H30.8333C33.1308 35 35 33.1308 35 30.8333V20.8333C35 18.5358 33.1308 16.6667 30.8333 16.6667ZM19.1667 18.3333H30.8333C32.2117 18.3333 33.3333 19.455 33.3333 20.8333V21.6667H16.6667V20.8333C16.6667 19.455 17.7883 18.3333 19.1667 18.3333ZM30.8333 33.3333H19.1667C17.7883 33.3333 16.6667 32.2117 16.6667 30.8333V23.3333H33.3333V30.8333C33.3333 32.2117 32.2117 33.3333 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    <div class=\"wcf--category-title label\">\r\n\t\t                    \t\t                    Cat\u00e9gorie                        <\/div>\r\n                        <ul class=\"wcf--category-list\">\r\n\t\t\t\t\t\t\t                                <li class=\"wcf--meta-category wcf-separator\"\r\n                                    data-separator=\"|\">\r\n                                    <a class=\"wcf-btn-default btn-hover-none\" href=\"https:\/\/biokteca.com\/fr\/category\/actualites\/\">\r\n\t\t\t\t\t\t\t\t\t\tActualit\u00e9s                                    <\/a>\r\n                                <\/li>\r\n\t\t\t\t\t\t\t                            <\/ul>\r\n                    <\/li>\r\n\t\t\t\t\t\t\t\t\t        <\/ul>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fb55d39 e-con-full e-flex e-con e-child\" data-id=\"fb55d39\" data-element_type=\"container\" 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35C25.1948 35 25.3855 34.9301 25.536 34.8028L29.2502 31.6669H31.6669C32.551 31.6669 33.3988 31.3157 34.024 30.6906C34.6491 30.0654 35.0003 29.2176 35.0003 28.3335V18.3334C35.0003 17.4493 34.6491 16.6015 34.024 15.9763C33.3988 15.3512 32.551 15 31.6669 15ZM33.3336 28.3335C33.3336 28.7756 33.158 29.1995 32.8454 29.512C32.5329 29.8246 32.1089 30.0002 31.6669 30.0002H29.2502C28.8563 30.0003 28.4751 30.14 28.1744 30.3944L25.0001 33.0753L21.8276 30.3944C21.5264 30.1396 21.1446 29.9999 20.7501 30.0002H18.3334C17.8913 30.0002 17.4674 29.8246 17.1549 29.512C16.8423 29.1995 16.6667 28.7756 16.6667 28.3335V18.3334C16.6667 17.8913 16.8423 17.4674 17.1549 17.1549C17.4674 16.8423 17.8913 16.6667 18.3334 16.6667H31.6669C32.1089 16.6667 32.5329 16.8423 32.8454 17.1549C33.158 17.4674 33.3336 17.8913 33.3336 18.3334V28.3335Z\" fill=\"#8DCF9B\"><\/path><path d=\"M20.8334 20.8334H25.0001C25.2212 20.8334 25.4331 20.7456 25.5894 20.5893C25.7457 20.4331 25.8335 20.2211 25.8335 20.0001C25.8335 19.7791 25.7457 19.5671 25.5894 19.4108C25.4331 19.2545 25.2212 19.1667 25.0001 19.1667H20.8334C20.6124 19.1667 20.4004 19.2545 20.2442 19.4108C20.0879 19.5671 20.0001 19.7791 20.0001 20.0001C20.0001 20.2211 20.0879 20.4331 20.2442 20.5893C20.4004 20.7456 20.6124 20.8334 20.8334 20.8334Z\" fill=\"#8DCF9B\"><\/path><path d=\"M29.1669 22.5001H20.8334C20.6124 22.5001 20.4004 22.5879 20.2442 22.7442C20.0879 22.9005 20.0001 23.1124 20.0001 23.3335C20.0001 23.5545 20.0879 23.7664 20.2442 23.9227C20.4004 24.079 20.6124 24.1668 20.8334 24.1668H29.1669C29.3879 24.1668 29.5998 24.079 29.7561 23.9227C29.9124 23.7664 30.0002 23.5545 30.0002 23.3335C30.0002 23.1124 29.9124 22.9005 29.7561 22.7442C29.5998 22.5879 29.3879 22.5001 29.1669 22.5001Z\" fill=\"#8DCF9B\"><\/path><path d=\"M29.1669 25.8335H20.8334C20.6124 25.8335 20.4004 25.9213 20.2442 26.0776C20.0879 26.2339 20.0001 26.4458 20.0001 26.6668C20.0001 26.8878 20.0879 27.0998 20.2442 27.2561C20.4004 27.4124 20.6124 27.5002 20.8334 27.5002H29.1669C29.3879 27.5002 29.5998 27.4124 29.7561 27.2561C29.9124 27.0998 30.0002 26.8878 30.0002 26.6668C30.0002 26.4458 29.9124 26.2339 29.7561 26.0776C29.5998 25.9213 29.3879 25.8335 29.1669 25.8335Z\" fill=\"#8DCF9B\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c6586a elementor-widget elementor-widget-wcf--blog--post--meta-info\" data-id=\"9c6586a\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--blog--post--meta-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <ul class=\"wcf--meta-list style-2\">\r\n\t        \t\t\t\r\n\t\t\t                <li class=\"wcf--view-wrap\">\r\n                    <div class=\"wcf--view-title label\">\r\n\t\t                \t\t                Temps de lecture                    <\/div>\r\n                    <div class=\"wcf--meta-view\">\r\n\t                    13&nbsp;\r\n                        <span>minutes read<\/span>\r\n                    <\/div>\r\n                <\/li>\r\n\t\t\t\t\t        <\/ul>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c00716d elementor-widget elementor-widget-wcf--image\" data-id=\"c00716d\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;wcf-image-animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;data-duration&quot;:1.5,&quot;ease&quot;:&quot;power2.out&quot;,&quot;fade-offset&quot;:50}\" data-widget_type=\"wcf--image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wcf--image\">\r\n\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1290\" height=\"720\" src=\"https:\/\/biokteca.com\/wp-content\/uploads\/2024\/11\/blog-necesidad-evaluacion-ok-int.webp\" class=\"attachment-full size-full 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e-flex elementor-invisible e-con e-child\" data-id=\"7c47826\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;,&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;on-scroll&quot;:1,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-cb8aec0 e-con-full e-flex e-con e-child\" data-id=\"cb8aec0\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81e50ef elementor-view-default elementor-position-top elementor-mobile-position-top elementor-widget elementor-widget-icon-box\" data-id=\"81e50ef\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon elementor-animation-\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"17\" height=\"19\" viewBox=\"0 0 17 19\" fill=\"none\"><path id=\"Vector\" d=\"M13.5353 11.8304C12.4643 11.8304 11.5055 12.3358 10.8693 13.128L6.73098 10.6975C6.85967 10.3229 6.93041 9.92007 6.93041 9.50029C6.93041 9.0806 6.85967 8.67779 6.73098 8.30317L10.869 5.87205C11.5051 6.66453 12.464 7.1701 13.5351 7.1701C15.4456 7.1701 16.9999 5.56165 16.9999 3.58451C17.0001 1.60795 15.4458 0 13.5353 0C11.6246 0 10.0701 1.60795 10.0701 3.58442C10.0701 4.0042 10.1407 4.40709 10.2695 4.7818L6.13126 7.213C5.49516 6.42094 4.53644 5.9157 3.46569 5.9157C1.55472 5.9157 0 7.52365 0 9.50021C0 11.4767 1.55472 13.0846 3.46569 13.0846C4.53644 13.0846 5.49508 12.5794 6.13118 11.7874L10.2695 14.218C10.1407 14.5927 10.07 14.9957 10.07 15.4156C10.07 17.392 11.6245 19 13.5352 19C15.4457 19 17 17.392 17 15.4156C17.0001 13.4388 15.4458 11.8304 13.5353 11.8304ZM13.5353 1.25432C14.7772 1.25432 15.7875 2.29958 15.7875 3.58442C15.7875 4.86993 14.7772 5.9157 13.5353 5.9157C12.2932 5.9157 11.2826 4.86993 11.2826 3.58442C11.2826 2.29958 12.2932 1.25432 13.5353 1.25432ZM3.46577 11.8304C2.2234 11.8304 1.21262 10.785 1.21262 9.50029C1.21262 8.21537 2.2234 7.1701 3.46577 7.1701C4.70765 7.1701 5.71794 8.21537 5.71794 9.50029C5.71794 10.785 4.70757 11.8304 3.46577 11.8304ZM13.5353 17.7458C12.2932 17.7458 11.2826 16.7004 11.2826 15.4157C11.2826 14.1304 12.2932 13.0847 13.5353 13.0847C14.7772 13.0847 15.7875 14.1304 15.7875 15.4157C15.7875 16.7004 14.7772 17.7458 13.5353 17.7458Z\" fill=\"#3F524C\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\taction\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19e0a0a elementor-widget elementor-widget-wcf--blog--post--social-share\" data-id=\"19e0a0a\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"wcf--blog--post--social-share.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <style>\r\n            .default-details-social-media {\r\n                display: flex;\r\n                margin: 0;\r\n                padding: 0;\r\n                list-style: none;\r\n            }\r\n\r\n            .default-details-social-media svg {\r\n                min-width: 7px;\r\n            }\r\n        <\/style>\r\n        <ul class=\"default-details-social-media\">\r\n\t\t\t                <li>\r\n                    <a href=\"https:\/\/biokteca.com\/fr\/necessite-devaluation-reglementaire-dans-les-investissements-biotechnologiques\/\"\r\n                       data-social=\"facebook\">\r\n                        <span class=\"wcf-social-icn \"><i aria-hidden=\"true\" class=\"share-ico binox-theme wcftheme-wcf-icon icon-wcf-facebook\"><\/i><\/span>\r\n                        <span class=\"info-s-title\"> Facebook <\/span>\r\n\t\t\t\t\t\t                            <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t                <li>\r\n                    <a href=\"https:\/\/biokteca.com\/fr\/necessite-devaluation-reglementaire-dans-les-investissements-biotechnologiques\/\"\r\n                       data-social=\"twitter\">\r\n                        <span class=\"wcf-social-icn \"><svg aria-hidden=\"true\" class=\"share-ico e-font-icon-svg e-fab-x-twitter\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M389.2 48h70.6L305.6 224.2 487 464H345L233.7 318.6 106.5 464H35.8L200.7 275.5 26.8 48H172.4L272.9 180.9 389.2 48zM364.4 421.8h39.1L151.1 88h-42L364.4 421.8z\"><\/path><\/svg><\/span>\r\n                        <span class=\"info-s-title\"> Twitter <\/span>\r\n\t\t\t\t\t\t                            <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t                <li>\r\n                    <a href=\"https:\/\/biokteca.com\/fr\/necessite-devaluation-reglementaire-dans-les-investissements-biotechnologiques\/\"\r\n                       data-social=\"linkedin\">\r\n                        <span class=\"wcf-social-icn \"><i aria-hidden=\"true\" class=\"share-ico binox-theme wcftheme-wcf-icon icon-wcf-linkdin\"><\/i><\/span>\r\n                        <span class=\"info-s-title\"> Linkedin <\/span>\r\n\t\t\t\t\t\t                            <span>\r\n                                                                                            <\/span>\r\n\t\t\t\t\t\t                    <\/a>\r\n                <\/li>\r\n\t\t\t        <\/ul>\r\n\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c4d9b4b e-con-full e-flex e-con e-child\" data-id=\"c4d9b4b\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7d9a514 e-con-full e-flex e-con e-child\" data-id=\"7d9a514\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-4abd5fe e-con-full e-flex e-con e-child\" data-id=\"4abd5fe\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-00b53a6 e-flex e-con-boxed e-con e-child\" data-id=\"00b53a6\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c4828d1 elementor-widget-mobile_extra__width-inherit wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"c4828d1\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Comme le montre le dernier rapport publi\u00e9 par AseBio, les entreprises de biotechnologie continuent de figurer parmi les cinq premi\u00e8res en termes d&rsquo;intensit\u00e9 d&rsquo;investissement en R&amp;D par rapport \u00e0 la production. L&rsquo;ann\u00e9e 2023 s&rsquo;ach\u00e8vera sur un investissement dans le secteur de la biotechnologie de plus de 228 millions d&rsquo;euros, un record.<\/p><p>En effet, la biotechnologie est consid\u00e9r\u00e9e comme l&rsquo;application de la technologie qui utilise les syst\u00e8mes biologiques et les organismes vivants &#8211; ou leurs d\u00e9riv\u00e9s &#8211; pour cr\u00e9er ou modifier des processus ou des produits \u00e0 des fins sp\u00e9cifiques, ses principaux domaines d&rsquo;application \u00e9tant la sant\u00e9, l&rsquo;agriculture et l&rsquo;\u00e9levage, l&rsquo;environnement et la fabrication industrielle.<\/p><p>En Espagne, 4 477 entreprises d\u00e9clarent mener des activit\u00e9s biotechnologiques, en utilisant la biotechnologie comme outil, comme activit\u00e9 secondaire ou en se consid\u00e9rant comme biotechnologiques (entreprises de biotechnologie), le domaine de la sant\u00e9 humaine \u00e9tant le principal domaine d&rsquo;activit\u00e9 des entreprises de biotechnologie (&gt;50%).<\/p><p>Dans le domaine des m\u00e9dicaments, un m\u00e9dicament \u00e0 usage humain est d\u00e9fini comme \u00abtoute substance ou composition pr\u00e9sent\u00e9e comme poss\u00e9dant des propri\u00e9t\u00e9s curatives ou pr\u00e9ventives \u00e0 l&rsquo;\u00e9gard des maladies humaines, ou pouvant \u00eatre utilis\u00e9e chez l&rsquo;homme ou administr\u00e9e \u00e0 l&rsquo;homme en vue de restaurer, corriger ou modifier des fonctions physiologiques en exer\u00e7ant une action pharmacologique, immunologique ou m\u00e9tabolique, ou en vue d&rsquo;\u00e9tablir un diagnostic m\u00e9dical\u00bb. La classification des m\u00e9dicaments est tr\u00e8s large et complexe, puisqu&rsquo;il est possible de trouver des classifications en fonction de leur indication th\u00e9rapeutique, de leur voie d&rsquo;administration, de leur famille, de leur \u00e9tat physique ou de leur origine (synth\u00e8se chimique, produits biologiques, radiopharmaceutiques, etc.), cette derni\u00e8re classification \u00e9tant la plus pertinente pour les soci\u00e9t\u00e9s de biotechnologie et celle qui peut directement conditionner les \u00e9tapes de financement d&rsquo;un projet et le co\u00fbt du d\u00e9veloppement.<\/p><p>En effet, la strat\u00e9gie d&rsquo;acc\u00e8s au march\u00e9, la strat\u00e9gie de financement final du produit commercial potentiel, les d\u00e9lais et les co\u00fbts de l&rsquo;\u00e9valuation r\u00e9glementaire, les organismes r\u00e9glementaires comp\u00e9tents, les tests de s\u00e9curit\u00e9 et de toxicologie non cliniques \u00e0 effectuer, le type d&rsquo;essai clinique \u00e0 r\u00e9aliser, les frais d&rsquo;\u00e9valuation et m\u00eame les acteurs sont diff\u00e9rents en termes de co\u00fbt et de temps, ce qui augmente ou diminue le co\u00fbt de l&rsquo;investissement, en fonction du cadre r\u00e9glementaire applicable.<\/p><p>La directive 2001\/83 d\u00e9finit un m\u00e9dicament biologique comme \u00ab tout produit dont la substance active est biologique, une substance active biologique \u00e9tant une substance qui est produite ou extraite \u00e0 partir d&rsquo;une source biologique et qui n\u00e9cessite, pour sa caract\u00e9risation et la d\u00e9termination de sa qualit\u00e9, une combinaison d&rsquo;essais physico-chimiques et biologiques ainsi que le proc\u00e9d\u00e9 de production et son contr\u00f4le \u00bb. Par cons\u00e9quent, les vaccins, les allerg\u00e8nes, les antig\u00e8nes, les hormones, les cytokines, les enzymes, les d\u00e9riv\u00e9s du sang humain, les s\u00e9rums, les immunoglobulines, les anticorps et les produits de fermentation sont consid\u00e9r\u00e9s comme des m\u00e9dicaments biologiques. Cependant, les produits d\u00e9riv\u00e9s du microbiote intestinal, les s\u00e9cr\u00e9tomes et d&rsquo;autres types de produits associ\u00e9s (ARN, plasmides, vecteurs, enzymes de restriction, etc.<\/p><p>La complexit\u00e9 du cadre r\u00e9glementaire r\u00e9side dans cette derni\u00e8re typologie de produits, puisque selon la finalit\u00e9 th\u00e9rapeutique du produit et le processus d&rsquo;obtention\/fabrication du produit, on peut se retrouver dans le cadre r\u00e9glementaire des m\u00e9dicaments de th\u00e9rapie innovante (MTI), des produits biologiques ou encore des produits de synth\u00e8se chimique.<\/p><p>En ce qui concerne les m\u00e9dicaments de th\u00e9rapie avanc\u00e9e, le cadre juridique est le r\u00e8glement (CE) 1394\/2007 et le d\u00e9cret royal 1\/2015, du 24 juillet, \u00e9tablissant un code communautaire relatif aux m\u00e9dicaments \u00e0 usage humain. Par d\u00e9finition, les m\u00e9dicaments de th\u00e9rapie innovante sont des m\u00e9dicaments biologiques \u00e0 usage humain, qui peuvent \u00eatre bas\u00e9s sur des g\u00e8nes (th\u00e9rapie g\u00e9nique), des cellules (th\u00e9rapie cellulaire), des tissus (ing\u00e9nierie tissulaire) ou une combinaison de ceux-ci (m\u00e9dicament combin\u00e9 de th\u00e9rapie innovante), y compris des produits d&rsquo;origine autologue, allog\u00e8ne ou x\u00e9nog\u00e8ne.<\/p><p>Par d\u00e9finition, dans le cas des m\u00e9dicaments de th\u00e9rapie cellulaire, le produit th\u00e9rapeutique contient ou est constitu\u00e9 de cellules ou de tissus ayant fait l&rsquo;objet d&rsquo;une manipulation substantielle, ou de cellules ou de tissus qui ne sont pas destin\u00e9s \u00e0 la m\u00eame fonction essentielle chez le receveur et le donneur. Dans le cas de l&rsquo;ing\u00e9nierie tissulaire, les produits contiennent ou sont constitu\u00e9s de cellules ou de tissus modifi\u00e9s et sont cens\u00e9s remplir une fonction de r\u00e9g\u00e9n\u00e9ration, de restauration ou de remplacement d&rsquo;un tissu humain ; dans la plupart des cas, ces cellules sont g\u00e9n\u00e9ralement accompagn\u00e9es de biomat\u00e9riaux.\u00a0 Enfin, les m\u00e9dicaments de th\u00e9rapie g\u00e9nique sont ceux dont l&rsquo;ingr\u00e9dient actif est un acide nucl\u00e9ique recombinant, utilis\u00e9 chez l&rsquo;homme pour r\u00e9guler, r\u00e9parer, remplacer, ajouter ou supprimer une s\u00e9quence g\u00e9n\u00e9tique. Il convient de noter que les vaccins contre les agents infectieux ne sont pas inclus dans la th\u00e9rapie g\u00e9nique et seraient donc consid\u00e9r\u00e9s comme des m\u00e9dicaments biologiques.<\/p><p>Par exemple, si l&rsquo;on consid\u00e8re les produits \u00e0 base d&rsquo;acide nucl\u00e9ique, on peut trouver des situations o\u00f9 ils sont consid\u00e9r\u00e9s comme des m\u00e9dicaments de synth\u00e8se chimique, des m\u00e9dicaments biologiques ou m\u00eame des m\u00e9dicaments de th\u00e9rapie g\u00e9nique.<\/p><p>Si l&rsquo;acide nucl\u00e9ique est synth\u00e9tis\u00e9 \u00e0 partir d&rsquo;un processus dans lequel les oligonucl\u00e9otides sont modifi\u00e9s par des r\u00e9actions de synth\u00e8se chimique, il ne pourrait pas \u00eatre consid\u00e9r\u00e9 comme un m\u00e9dicament biologique puisqu&rsquo;il ne rel\u00e8verait pas de la d\u00e9finition de la directive 2001\/83, et ne pourrait donc pas \u00eatre consid\u00e9r\u00e9 comme un m\u00e9dicament de th\u00e9rapie g\u00e9nique, puisque par d\u00e9finition les ATMP sont caract\u00e9ris\u00e9s comme un m\u00e9dicament biologique.\u00a0 Par cons\u00e9quent, toutes les r\u00e9glementations applicables aux m\u00e9dicaments synth\u00e9tis\u00e9s chimiquement lui sont applicables.<\/p><p>D&rsquo;autre part, nous pourrions \u00eatre confront\u00e9s \u00e0 un produit qui, s&rsquo;il \u00e9tait constitu\u00e9 d&rsquo;un acide nucl\u00e9ique recombinant, serait consid\u00e9r\u00e9 comme un m\u00e9dicament biologique, mais ne serait pas consid\u00e9r\u00e9 comme un m\u00e9dicament de th\u00e9rapie g\u00e9nique, en raison du m\u00e9canisme d&rsquo;action d\u00e9clar\u00e9 par la soci\u00e9t\u00e9 de biotechnologie. \u00c9tant donn\u00e9 que, par d\u00e9finition, les m\u00e9dicaments de th\u00e9rapie g\u00e9nique sont des m\u00e9dicaments biologiques qui r\u00e9pondent aux deux caract\u00e9ristiques suivantes :<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f2f0b3f e-con-full e-flex e-con e-child\" data-id=\"f2f0b3f\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;on-scroll&quot;:&quot;1&quot;,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-472f06f e-con-full e-flex e-con e-child\" data-id=\"472f06f\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60e9a1a elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"60e9a1a\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"70\" height=\"53\" viewBox=\"0 0 70 53\" fill=\"\"><path d=\"M29.1667 -3.56976e-06L29.1667 26.5L10 53L0 53L16.6667 26.5L3.33334 26.5L3.33334 -5.82818e-06L29.1667 -3.56976e-06ZM70 0L70 26.5L50.8333 53L40.8333 53L57.5 26.5L44.1667 26.5L44.1667 -2.25842e-06L70 0Z\" fill=\"\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a2dfc3 e-con-full e-flex e-con e-child\" data-id=\"3a2dfc3\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-25b4f6f wcf-t-animation-none elementor-widget elementor-widget-heading\" data-id=\"25b4f6f\" data-element_type=\"widget\" data-settings=\"{&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<p class=\"elementor-heading-title elementor-size-default\">comprend une substance active contenant ou consistant en un acide nucl\u00e9ique recombinant utilis\u00e9 ou administr\u00e9 \u00e0 des \u00eatres humains dans le but de r\u00e9guler, de r\u00e9parer, de remplacer, d'ajouter ou de supprimer une s\u00e9quence g\u00e9n\u00e9tique.\n- son effet th\u00e9rapeutique, prophylactique ou diagnostique d\u00e9pend directement de la s\u00e9quence d'acide nucl\u00e9ique recombinant qu'il contient ou du produit de l'expression g\u00e9n\u00e9tique de cette s\u00e9quence\n<\/p>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a006157 e-flex e-con-boxed e-con e-child\" data-id=\"a006157\" data-element_type=\"container\" data-settings=\"{&quot;wcf_enable_cursor_hover_effect_text&quot;:&quot;View&quot;,&quot;wcf-animation&quot;:&quot;none&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45c3698 elementor-widget__width-auto elementor-widget-divider--view-line_text elementor-widget-divider--element-align-right elementor-widget elementor-widget-divider\" data-id=\"45c3698\" data-element_type=\"widget\" data-settings=\"{&quot;wcf-animation&quot;:&quot;none&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t\t<p class=\"elementor-divider__text elementor-divider__element\">\n\t\t\t\tM\u00e9decine de d\u00e9finition\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b95678b wcf-t-animation-none elementor-widget elementor-widget-text-editor\" data-id=\"b95678b\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;wcf_text_animation&quot;:&quot;none&quot;,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Un grand nombre de soci\u00e9t\u00e9s de biotechnologie nationales et internationales d\u00e9veloppent des produits tr\u00e8s innovants, pour lesquels il est parfois complexe de d\u00e9finir un cadre r\u00e9glementaire unique d&rsquo;application, car dans la grande majorit\u00e9 des projets, celui-ci variera en fonction de l&rsquo;utilisation pr\u00e9vue ou de la finalit\u00e9 th\u00e9rapeutique du produit et du m\u00e9canisme par lequel il est obtenu, comme d\u00e9taill\u00e9 ci-dessus.<\/p><p>Par cons\u00e9quent, en raison de la complexit\u00e9 r\u00e9glementaire extr\u00eamement \u00e9lev\u00e9e associ\u00e9e aux produits biotechnologiques, il est crucial pour les entreprises de biotechnologie et leurs investisseurs de disposer d&rsquo;une strat\u00e9gie r\u00e9glementaire claire et solide d\u00e8s le d\u00e9but du projet, afin de pouvoir concevoir les phases du projet d\u00e8s les premi\u00e8res \u00e9tapes, en suivant la voie r\u00e9glementaire correcte et en ayant les bons partenaires qui respectent les certifications requises, qui diff\u00e8rent selon qu&rsquo;il s&rsquo;agit d&rsquo;un produit de synth\u00e8se, d&rsquo;un produit biologique ou d&rsquo;un m\u00e9dicament de th\u00e9rapie avanc\u00e9e.<\/p><p>En conclusion, l&rsquo;\u00e9valuation financi\u00e8re des innovations biotechnologiques doit \u00eatre associ\u00e9e non seulement \u00e0 une \u00e9valuation scientifique et technique de l&rsquo;innovation, mais aussi \u00e0 une \u00e9valuation r\u00e9glementaire solide r\u00e9alis\u00e9e par des sp\u00e9cialistes.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04dc47d elementor-widget elementor-widget-wcf--blog--post--tags\" data-id=\"04dc47d\" data-element_type=\"widget\" data-settings=\"{&quot;on-scroll&quot;:&quot;1&quot;,&quot;data-duration&quot;:0.75,&quot;wcf-animation&quot;:&quot;fade&quot;,&quot;fade-offset&quot;:40,&quot;delay&quot;:0.15,&quot;fade-from&quot;:&quot;bottom&quot;,&quot;ease&quot;:&quot;power2.out&quot;}\" data-widget_type=\"wcf--blog--post--tags.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t        <div class=\"wcf--post-tags\">\r\n\t\t\t        <\/div>\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Comme le montre le dernier rapport publi\u00e9 par AseBio, les entreprises biotechnologiques continuent de se maintenir parmi les cinq premi\u00e8res positions en termes d\u2019intensit\u00e9 des investissements en R&#038;D.<\/p>\n","protected":false},"author":5,"featured_media":17764,"comment_status":"open","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[41],"tags":[],"class_list":["post-17818","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"_links":{"self":[{"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/posts\/17818","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/comments?post=17818"}],"version-history":[{"count":5,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/posts\/17818\/revisions"}],"predecessor-version":[{"id":18240,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/posts\/17818\/revisions\/18240"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/media\/17764"}],"wp:attachment":[{"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/media?parent=17818"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/categories?post=17818"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/biokteca.com\/fr\/wp-json\/wp\/v2\/tags?post=17818"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}