Regulations, safety & supply

<!doctype html>     <html class="no-js" lang="">  <head>  <script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-NXDBSJM');</script>   <script src="https://consentag.eu/public/3.0.1/consenTag.js"></script> <script type="text/javascript"> consenTag.init({ containerId: "68805734", silentMode: true }, true); </script>   <meta content="text/html;charset=utf-8" http-equiv="Content-Type"> <meta content="utf-8" http-equiv="encoding">  <meta http-equiv="X-UA-Compatible" content="IE=edge"/>  <meta http-equiv="Author" content="EFPIA EU"> <meta http-equiv="X-Content-Type-Options" content="nosniff"> <meta http-equiv="X-Frame-Options" content="SAMEORIGIN"> <meta http-equiv="X-X-XSS-Protection: 1" mode="block"> <meta name="viewport" content="width=device-width, initial-scale=1"> <meta name="keywords" content="Explore, process, medicine, development, Discovery , regulatory authority, treatment, clinical trial, Good Clinical Practice, Good Manufacturing Practice, clinical research, marketing authorisation, safety, effectiveness, new medicine, access, Pharmacovigilance, Clinical development, Regulatory approval, Data, medicines use, regulatory affairs, regulatory" /> <meta name="description" content="The Scientific, Regulatory, Manufacturing (SRM) team at EFPIA supports a lot of specialised experts groups, e.g. Clinical Development Expert Group, Technical Development Expert Group, Pharmacovigilance Expert Group and others. These committees draft EFPIA position papers which then are agreed by the EFPIA Secretariat. Several of these position papers can be found here on the website." /> <meta charset="utf-8"> <title>Regulations, safety & supply</title> <link rel="apple-touch-icon"> <link rel="stylesheet" href="/css/jquery-ui.min.css?v=1.0.0.0"> <link href="/css/error.css?v=7052fdace13829e5ff0e7d49c99bc4f575eb526e" rel="stylesheet" /><link href="/css/app.min.css?v=7052fdace13829e5ff0e7d49c99bc4f575eb526e" rel="stylesheet" /> <link rel="apple-touch-icon" sizes="180x180" href="/favicon/apple-touch-icon.png"> <link rel="icon" type="image/png" sizes="32x32" href="/favicon/favicon-32x32.png"> <link rel="icon" type="image/png" sizes="16x16" href="/favicon/favicon-16x16.png"> <link rel="manifest" href="/favicon/manifest.json"> <link rel="mask-icon" color="#5bbad5" href="/favicon/safari-pinned-tab.svg"> <link rel="shortcut icon" href="/favicon/favicon.ico"> <meta name="msapplication-config" content="/favicon/browserconfig.xml"> <meta name="theme-color" content="#ffffff"> <link rel="stylesheet" integrity="sha512-W/zrbCncQnky/EzL+/AYwTtosvrM+YG/V6piQLSe2HuKS6cmbw89kjYkp3tWFn1dkWV7L1ruvJyKbLz73Vlgfg==" crossorigin="anonymous" referrerpolicy="no-referrer" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/6.4.2/css/brands.min.css" /> <link rel="stylesheet" integrity="sha512-rOTVxSYNb4+/vo9pLIcNAv9yQVpC8DNcFDWPoc+gTv9SLu5H8W0Dn7QA4ffLHKA0wysdo6C5iqc+2LEO1miAow==" crossorigin="anonymous" referrerpolicy="no-referrer" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/6.4.2/css/regular.min.css" /> <link rel="stylesheet" integrity="sha512-sx5f0oBw5bYJXpvIAFXqCP3p5heQFrIDUJEUu2ja7WbmFHBHKY565OjQK2PQM+8PruMwcDR18WEIOse4qEBJ8Q==" crossorigin="anonymous" referrerpolicy="no-referrer" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/6.4.2/css/v4-font-face.min.css" /> <meta property="og:title" content="Regulations, safety & supply" /> <meta property="og:type" content="website" /> <meta property="og:url" content="https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" /> <script id="Cookiebot" data-cbid="12849ae9-a830-4c42-950e-8784a5a8e44d" type="text/javascript" async src="https://consent.cookiebot.com/uc.js"></script>  <script async src="https://www.googletagmanager.com/gtag/js?id=G-TLWDSS0274"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-TLWDSS0274'); </script> </head> <body class=" notransition">  <noscript> <iframe src="https://www.googletagmanager.com/ns.html?id=GTM-NXDBSJM" height="0" width="0" style="display:none;visibility:hidden"></iframe> </noscript>  <div class="wrapper" data-cookiemessage="This website uses cookies to offer you a better browsing experience. If you continue browsing our website, you accept these cookies. Find out more on how we use cookies and how you can change your settings." data-policyurl="/privacy-notice/" data-policy="Read Cookie Policy" data-accepttext="Accept Cookies"> <div> <section class="navigation"> <div id="sidebar"> <div class="navigation__wrapper"> <nav> <div class="navigation__mobile_header"> <i id="navigation__close" class="navigation__close material-icons">close</i> </div> <ul class="navigation__list"> <li> <a href="https://efpia.eu/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-home"></i> <div> <span>Home</span> </div> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="10041"> <div class="navigation__link-container"> <i class="navigation__icon icon-support"></i> <div> <span>#WE-WONT-REST</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="1075"> <div class="navigation__link-container"> <i class="navigation__icon icon-speech"></i> <div> <span>News & Events</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup current" data-id="1078"> <div class="navigation__link-container"> <i class="navigation__icon icon-loop"></i> <div> <span>About medicines</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="16790"> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <div> <span>More Than Medicine</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="https://efpia.eu/pharmaceutical-legislation/" class="navigation--link " data-id="17887"> <div class="navigation__link-container"> <i class="navigation__icon icon-book-open"></i> <div> <span>Pharmaceutical Legislation</span> </div> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="1077"> <div class="navigation__link-container"> <i class="navigation__icon icon-notebook"></i> <div> <span>Relationships & code</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="1076"> <div class="navigation__link-container"> <i class="navigation__icon icon-layers"></i> <div> <span>Publications</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="#/" class="navigation--link navigation--has-submenu no-popup " data-id="1079"> <div class="navigation__link-container"> <i class="navigation__icon icon-people"></i> <div> <span>About us</span> </div> <i class="material-icons chev-right">chevron_right</i> </div> </a> </li> <li> <a href="https://efpia.eu/contact-us/" class="navigation--link " data-id="1090"> <div class="navigation__link-container"> <i class="navigation__icon icon-note"></i> <div> <span>Contact us</span> </div> </div> </a> </li> <li class="navigation__kmslogin"> <a href="http://kms.efpia.eu/user/login?destination=/" target="_blank" class="navigation--link"> <div class="navigation__link-container"> <i class="navigation__icon icon-lock"></i> <div> <span>KMS Login</span> </div> </div> </a> </li> </ul> </nav> </div> </div> <div id="sidebar__submenu"> <div class="subnavigation__wrapper"> <nav> <div class="navigation__mobile_header"> <i id="subnavigation__back" class="navigation__back material-icons"> arrow_back</i> <i id="subnavigation__close" class="navigation__close material-icons">close</i> </div> <ul class="subnavigation__list" id="submenu-10041"> <li> <a href="https://efpia.eu/we-wont-rest/" class="subnavigation__header "> <i class="navigation__icon icon-support"></i> <span>#WE-WONT-REST</span> </a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/we-wont-rest/patient-stories/" class="navigation--link no-popup " data-id="12213"> <div class=" navigation__link-container"> <i class="navigation__icon icon-speech"></i> <span>Patient stories</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=11228" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Alzheimer's patient story</span> </div> </a> </li> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=15647" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Blood cancer patient story</span> </div> </a> </li> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=15648" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Lung cancer patient story</span> </div> </a> </li> <li> <a href="/we-wont-rest/patient-stories/?locId=0&orgId=0&diseaseId=12642" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Haemophilia patient story</span> </div> </a> </li> </ul> </li> <li class=""> <a href="https://efpia.eu/we-wont-rest/members-updates/" class="navigation--link no-popup " data-id="15663"> <div class=" navigation__link-container"> <i class="navigation__icon icon-speech"></i> <span>Members updates</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/we-wont-rest/imagine/" class="navigation--link no-popup " data-id="18132"> <div class=" navigation__link-container"> <i class="navigation__icon icon-magic-wand"></i> <span>Imagine</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1075"> <li> <a href="https://efpia.eu/news-events/" class="subnavigation__header "> <i class="navigation__icon icon-speech"></i> <span>News & Events</span> </a> </li> <li class=""> <a href="https://efpia.eu/news-events/the-efpia-view/" class="navigation--link no-popup " data-id="1094"> <div class=" navigation__link-container"> <i class="navigation__icon icon-eye"></i> <span>The EFPIA View</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/news-events/events/" class="navigation--link no-popup " data-id="1111"> <div class=" navigation__link-container"> <i class="navigation__icon icon-direction"></i> <span>Events</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/news-events/newsletter/" class="navigation--link no-popup " data-id="1118"> <div class=" navigation__link-container"> <i class="navigation__icon icon-envelope"></i> <span>Newsletter</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1078"> <li> <a href="https://efpia.eu/about-medicines/" class="subnavigation__header currentpage"> <i class="navigation__icon icon-loop"></i> <span>About medicines</span> </a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/development-of-medicines/" class="navigation--link no-popup currentpage" data-id="1081"> <div class=" navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Development of medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/animal-use-and-welfare/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Animal Use and Welfare</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/antimicrobial-resistance-amr/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Antimicrobial resistance (AMR)</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/digital-health/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Digital Health</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/intellectual-property/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Intellectual Property</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/precision-medicine/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Precision medicine</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/public-private-partnerships/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Public-private partnerships</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" class="navigation--link currentpage"> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Regulations, safety & supply</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/smes-in-europe/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>SMEs in Europe</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/trade/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Trade</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/unmet-medical-need/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Unmet medical need</span> </div> </a> </li> </ul> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/use-of-medicines/" class="navigation--link no-popup " data-id="1082"> <div class=" navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Use of medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/hta-relative-efficacy-assessment/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>HTA & Relative Efficacy Assessment</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Disease-specific groups</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Healthcare Systems</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/value-of-medicines/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-heart"></i> <span>Value of medicines</span> </div> </a> </li> </ul> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/about-medicines/access-to-medicines/" class="navigation--link no-popup " data-id="16315"> <div class=" navigation__link-container"> <i class="navigation__icon icon-paper-plane"></i> <span>Access to medicines</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/about-medicines/access-to-medicines/back-innovation-boost-access/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-paper-plane"></i> <span>Back Innovation, Boost Access</span> </div> </a> </li> </ul> </li> </ul> <ul class="subnavigation__list" id="submenu-16790"> <li> <a href="https://efpia.eu/more-than-medicine/" class="subnavigation__header "> <i class="navigation__icon icon-ma-compare"></i> <span>More Than Medicine</span> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/improving-health/" class="navigation--link no-popup " data-id="16650"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Improving Health</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/turning-science-into-new-medicines/" class="navigation--link no-popup " data-id="16651"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Turning science into new medicines</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/responsible-innovation/" class="navigation--link no-popup " data-id="16652"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Responsible Innovation</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/more-than-medicine/economic-impact/" class="navigation--link no-popup " data-id="16653"> <div class=" navigation__link-container"> <i class="navigation__icon "></i> <span>Economic impact</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-17887"> <li> <a href="https://efpia.eu/pharmaceutical-legislation/" class="subnavigation__header "> <i class="navigation__icon icon-book-open"></i> <span>Pharmaceutical Legislation</span> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1077"> <li> <a href="https://efpia.eu/relationships-code/" class="subnavigation__header "> <i class="navigation__icon icon-notebook"></i> <span>Relationships & code</span> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/the-efpia-code/" class="navigation--link no-popup " data-id="13034"> <div class=" navigation__link-container"> <i class="navigation__icon icon-notebook"></i> <span>The EFPIA Code</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/patient-organisations/" class="navigation--link no-popup " data-id="1089"> <div class=" navigation__link-container"> <i class="navigation__icon icon-people"></i> <span>Patient organisations</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/healthcare-professionals-hcps/" class="navigation--link no-popup " data-id="1080"> <div class=" navigation__link-container"> <i class="navigation__icon icon-book-open"></i> <span>Healthcare professionals (HCPs)</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/disclosure-of-payments/" class="navigation--link no-popup " data-id="10735"> <div class=" navigation__link-container"> <i class="navigation__icon icon-user"></i> <span>Disclosure of payments</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/national-codes/" class="navigation--link no-popup " data-id="1093"> <div class=" navigation__link-container"> <i class="navigation__icon icon-globe-alt"></i> <span>National codes</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/relationships-code/eu-institutions/" class="navigation--link no-popup " data-id="1088"> <div class=" navigation__link-container"> <i class="navigation__icon icon-grid"></i> <span>EU institutions</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1076"> <li> <a href="https://efpia.eu/publications/" class="subnavigation__header "> <i class="navigation__icon icon-layers"></i> <span>Publications</span> </a> </li> <li class=""> <a href="https://efpia.eu/publications/data-center/" class="navigation--link no-popup " data-id="1123"> <div class=" navigation__link-container"> <i class="navigation__icon icon-pie-chart"></i> <span>Data center</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/publications/downloads/" class="navigation--link no-popup " data-id="6474"> <div class=" navigation__link-container"> <i class="navigation__icon icon-cloud-download"></i> <span>Downloads</span> </div> </a> </li> <li class="has-tertiary-nav"> <a href="https://efpia.eu/publications/cancer-comparator-report/" class="navigation--link no-popup " data-id="14162"> <div class=" navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Comparator Report</span> <i class="material-icons expand-more">expand_more</i> <i class="material-icons expand-less">expand_less</i> <i class="material-icons chev-right">chevron_right</i> </div> </a> <ul class="tertiary__navigation"> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/about/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>About</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/recommendations/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Recommendations</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-cases/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Cases</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-deaths/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Deaths</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/survival/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Survival</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-care/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Care</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-types/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Types</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/resources/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Resources</span> </div> </a> </li> </ul> </li> </ul> <ul class="subnavigation__list" id="submenu-1079"> <li> <a href="https://efpia.eu/about-us/" class="subnavigation__header "> <i class="navigation__icon icon-people"></i> <span>About us</span> </a> </li> <li class=""> <a href="https://efpia.eu/about-us/who-we-are/" class="navigation--link no-popup " data-id="1096"> <div class=" navigation__link-container"> <i class="navigation__icon icon-organization"></i> <span>Who we are</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/about-us/efpia-japan/" class="navigation--link no-popup " data-id="1092"> <div class=" navigation__link-container"> <i class="navigation__icon icon-globe"></i> <span>EFPIA Japan</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/about-us/membership/" class="navigation--link no-popup " data-id="2376"> <div class=" navigation__link-container"> <i class="navigation__icon icon-user"></i> <span>Membership</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/about-us/job-vacancies/" class="navigation--link no-popup " data-id="11565"> <div class=" navigation__link-container"> <i class="navigation__icon icon-people"></i> <span>Job vacancies</span> </div> </a> </li> <li class=""> <a href="https://efpia.eu/about-us/partnerships-initiatives/" class="navigation--link no-popup " data-id="18931"> <div class=" navigation__link-container"> <i class="navigation__icon icon-size-actual"></i> <span>Partnerships & Initiatives</span> </div> </a> </li> </ul> <ul class="subnavigation__list" id="submenu-1090"> <li> <a href="https://efpia.eu/contact-us/" class="subnavigation__header "> <i class="navigation__icon icon-note"></i> <span>Contact us</span> </a> </li> </ul> </nav> </div> </div> <div id="tertiary__menu-mobile"> <div class="navigation__mobile_header"> <i id="tertiary__back" class="navigation__back material-icons"> arrow_back</i> <i id="tertiary__close" class="navigation__close material-icons">close</i> </div> <ul class="tertiary-id-1081 tertiary__list"> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/" class="subnavigation__header currentpage"> <i class="navigation__icon icon-docs"></i> <span>Development of medicines</span> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/animal-use-and-welfare/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-bubbles"></i> <span>Animal Use and Welfare</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/antimicrobial-resistance-amr/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-globe"></i> <span>Antimicrobial resistance (AMR)</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/digital-health/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-graph"></i> <span>Digital Health</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/intellectual-property/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-docs"></i> <span>Intellectual Property</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/precision-medicine/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-target"></i> <span>Precision medicine</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/public-private-partnerships/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-bulb"></i> <span>Public-private partnerships</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" class="navigation--link currentpage"> <div class="navigation__link-container"> <i class="navigation__icon icon-support"></i> <span>Regulations, safety & supply</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/smes-in-europe/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-eye"></i> <span>SMEs in Europe</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/trade/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-globe"></i> <span>Trade</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/development-of-medicines/unmet-medical-need/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-globe"></i> <span>Unmet medical need</span> </div> </a> </li> </ul> <ul class="tertiary-id-1082 tertiary__list"> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/" class="subnavigation__header "> <i class="navigation__icon icon-heart"></i> <span>Use of medicines</span> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/hta-relative-efficacy-assessment/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-graph"></i> <span>HTA & Relative Efficacy Assessment</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-target"></i> <span>Disease-specific groups</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-ma-compare"></i> <span>Healthcare Systems</span> </div> </a> </li> <li> <a href="https://efpia.eu/about-medicines/use-of-medicines/value-of-medicines/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon icon-people"></i> <span>Value of medicines</span> </div> </a> </li> </ul> <ul class="tertiary-id-16315 tertiary__list"> <li> <a href="https://efpia.eu/about-medicines/access-to-medicines/" class="subnavigation__header "> <i class="navigation__icon icon-paper-plane"></i> <span>Access to medicines</span> </a> </li> <li> <a href="https://efpia.eu/about-medicines/access-to-medicines/back-innovation-boost-access/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Back Innovation, Boost Access</span> </div> </a> </li> </ul> <ul class="tertiary-id-14162 tertiary__list"> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/" class="subnavigation__header "> <i class="navigation__icon icon-ma-compare"></i> <span>Cancer Comparator Report</span> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/about/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>About</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/recommendations/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Recommendations</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-cases/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Cancer Cases</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-deaths/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Cancer Deaths</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/survival/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Survival</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-care/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Cancer Care</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/cancer-types/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Cancer Types</span> </div> </a> </li> <li> <a href="https://efpia.eu/publications/cancer-comparator-report/resources/" class="navigation--link "> <div class="navigation__link-container"> <i class="navigation__icon "></i> <span>Resources</span> </div> </a> </li> </ul> </div> </section> <section id="content" class="content__wrapper"> <header class=" site__header"> <div class="header__burger mobile"> <i class="icon-menu"></i> </div> <div class="header__logo"> <a href="https://efpia.eu/"> </a> </div> <div class="header__breadcrumb"> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/"> About medicines</a> </div> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/development-of-medicines/"> Development of medicines</a> </div>  <span class="truncated-breadcrumb"> Regulations, safety... </span>  <span class="untruncated-breadcrumb"> Regulations, safety & supply </span> </div> <div class="header__search"> <div class="search__container"> <form action="https://efpia.eu/search-results/"> <input type="text" name="query" id="header-search" class="search__input" placeholder="Search" /> <span class="fa fa-search desktop-search"></span> </form> </div> <div class="opensearch__mobile"> <span class="fa fa-search"></span> </div> </div> </header> <div class="searchbar__mobile"> <form action="https://efpia.eu/search-results/"> <i class="material-icons searchbar__close">close</i> <input type="text" placeholder="" name="query" /> <span class="fa fa-search submit-search-mob"></span> </form> </div> <div class="content__section"> <header role="banner" style="background-image: url(/media/25547/pills-3.jpg?rxy=0.4547738693467337,0.7705479452054794&amp;width=1200&amp;height=490); background-position: 45% 77%; " class=" " id="banner-image"> <div class="text__wrapper"> <div class="header__blurb"> <h2>Regulations, safety & supply</h2> </div> </div> </header>  <div class="video__modal"> <div class="video__modal-cell"> <div class="video__close"> <a href="#" class="icon-close"></a> </div> <div class="videoWrapper">  <iframe id="player" width="420" height="315" frameborder="0" allowfullscreen="allowfullscreen" mozallowfullscreen="mozallowfullscreen" msallowfullscreen="msallowfullscreen" oallowfullscreen="oallowfullscreen" webkitallowfullscreen="webkitallowfullscreen"></iframe> </div> </div> </div> <nav class="section-navigation"> <div class="container">  <div class="section-navigation__nav-items social"> <div class="section-navigation__nav-items__links"> <a href="#" onclick="window.print()" class="print-button"> <i class="material-icons">print</i> <span>Print</span> </a> <a href="http://www.facebook.com/sharer/sharer.php?u=https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" class="section-navigation__nav-items__links--social" title="Share on Facebook" target="_blank"> <i class="fa fa-facebook-square"></i> </a> <a href="http://twitter.com/share?url=https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/&text=Regulations, safety & supply&via=Efpia" class="section-navigation__nav-items__links--social" title="Share on Twitter" target="_blank"> <i class="fa fa-twitter-square"></i> </a> <a href="http://www.linkedin.com/shareArticle?url=https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/&title=Regulations, safety & supply&source=https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/" class="section-navigation__nav-items__links--social" title="Share on LinkedIn" target="_blank"> <i class="fa fa-linkedin-square"></i> </a> </div> </div> </div> </nav> <section class="content__container content__container--no-padding-m"> <div class="umb-grid"> <div class="grid-section"> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-title-orange">Safer, better, faster.</span></p> </div> </div> </div> </div> </div> <div class="greyback greentitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <p> </p> <div style="text-align: left;"><span class="rte-paragraph"><strong>Pharmaceutical regulation</strong> sets the scientific standards and framework for getting high quality, safe and effective medicines to patients. It is an essential component of the process that turns the spark of an idea into a licensed therapeutic that can transform the lives of patients across Europe.</span></div> <div style="text-align: left;"><span class="rte-paragraph"><br /></span><span class="rte-paragraph">Our well-functioning regulatory system also plays a significant role in enhancing Europe's competitiveness in the global race of attracting investments in the life sciences sector. This is especially important given the fierce competition we face from other global economies, particularly the United States and China.</span></div> </div> </div> <div class="col-md-6 column"> <div > <p> </p> <p><span class="Subheading">Number of new chemical or biological entities </span></p> <img src="/media/677122/1.png" alt=""> <p class="caption"><em>Source: SCRIP – EFPIA calculations (according to nationality of mother company) – <a href="https://www.efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf" target="_blank">link</a></em></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div style="text-align: left;"></div> <div style="text-align: left;"></div> <div style="text-align: left;"><span class="rte-paragraph">To remain competitive and to become a world leader in medical innovation, Europe must continue to evolve its regulatory system to stay at the cutting edge of regulatory science and policy.<br /><br /></span><span class="rte-paragraph">With the <a rel="noopener" href="https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en" target="_blank">revision of the EU pharmaceutical legislation</a>, we are now in an important moment for Europe’s ambition to be a global leader in innovation.</span></div> <div style="text-align: left;"><span class="rte-paragraph"></span></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <p> </p> <p><span class="rte-paragraph"><strong>Regulatory science</strong> is a field looking into developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of vaccines and treatments, in order to facilitate a sound and transparent regulatory decision-making. It can be a fast-moving and exciting area, and is transforming the way new therapeutics are developed through advances in science, data analytics, the ability to collect real-world data and turn them into real-world evidence. <br /><br /></span></p> </div> </div> <div class="col-md-6 column"> <div > <p> </p> <p><a data-id="13823" href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-road-to-innovation/" title="Regulatory Road to Innovation"><img id="__mcenew" src="/media/541103/screenshot-2020-04-21-at-152729.png" alt="" rel="13838" data-id="13838" /></a></p> <p style="text-align: center;"><a data-id="13823" href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-road-to-innovation/" title="Regulatory Road to Innovation">Discover more about our<br />Regulatory Road to Innovation</a></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="Subheading">The total number of Next-Generation Biotherapeutics (NGBs) – defined as cell, gene and nucleotide therapies – in the development pipeline went from 120 in 2015 to 269 by the end of 2018.</span></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-8 column"> <div > <img src="/media/589597/the-total-number-of-next-generation-biotherapeutics.png" alt=""> </div> </div> <div class="col-md-4 column"> <div > <p><span class="rte-paragraph">NGBs make around 10% of the total late-stage R&D pipeline and have more than doubled in number over the past three years as new pathways for disease treatment and cure.<br /><br /></span></p> <p class="caption"><em>Source: IQVIA, The Changing Landscape of Research and Development, April 2019, </em><a href="https://www.healthindustryhub.com.au/wp-content/uploads/2019/05/the-changing-landscape-of-research-and-development.pdf"><em>link</em></a></p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p> </p> <span class="rte-heading">Working together to deliver more for patients, in Europe and beyond</span> <table border="0" cellspacing="0" cellpadding="0" style="background: #f0f6f7; float: right; margin: 0 0 20px 20px; padding: 30px !important;"> <tbody> <tr> <td width="400" style="padding: 30px;"> <p>EFPIA and its members provide their practical experience and improvement suggestions on all phases of medicines development, manufacturing and regulatory aspects. All of <strong>EFPIA’s submissions to regulatory consultations</strong> are made available online and you can access them <a href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-affairs/" target="_blank">here</a>.</p> </td> </tr> </tbody> </table> <span class="rte-paragraph">The European regulatory framework provides the clear time-points at which regulators, patients and industry come together to address different issues, with clear roles and responsibilities of every player.</span> <span class="rte-paragraph">Working according to the rules set by the regulatory framework means working on a wide range of subjects such as having a scientific dialogue and getting advice in different phases of medicine’s development, until their marketing authorisation.<br /><br /> The framework also covers the provision of evidence that medicines are researched and manufactured in compliance with regulations (Good Laboratory/Clinical/Manufacturing Practices), and the continuous monitoring of medicines once they have entered the market in order to detect potential safety and quality issues. An important role the framework plays is around relaying information and informing the development and decision making across medicine’s lifecycle - including real-world data collected in patients’ Health Records or registries.<br /><br /> As part of the medicine’s licence, environmental and sustainable manufacturing issues need to be addressed as well, and compliance with the respective legislative requirements needs to be proven. Furthermore, there is always a need for a revision or an update to the marketing authorisation details at some point, such as routine continuous updates to the existing licence. New scientific information could also lead to an extension of application to be able to give the medicine to additional patients’ groups, such as children, pregnant women and elderly.<br /><br /> Upon regulatory approval, there is a separate evaluation and a decision (<a href="/about-medicines/use-of-medicines/hta-relative-efficacy-assessment/" target="_blank">Health Technology Assessment</a>) on price, as well as negotiations of potential reimbursement conditions covered by national healthcare systems.</span> <p> </p> <span class="rte-heading">Looking beyond Europe</span> <table border="0" cellspacing="0" cellpadding="0" style="background: #f0f6f7; float: right; margin: 0 0 20px 20px; padding: 30px !important;"> <tbody> <tr> <td width="400" style="padding: 30px;"> <p>EFPIA and the European Commission/European Medicines Agency are also founding members of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. You can find more information on ICH via this <a href="https://www.ich.org/" target="_blank">link</a>.</p> </td> </tr> </tbody> </table> <span class="rte-paragraph">Regulators across the world are facing a number of common challenges including greater interdependence, a rising workload and limited resources. There are clear advantages for patients, industry and healthcare systems and for international regulators to work together to achieve a more integrated approach to regulation. <br /><br /> Global regulatory convergence is a means of aligning regulatory requirements across the world via a process of gradual uptake of internationally recognised technical and procedural standards and principles, with the aim of improving healthcare. It does not necessarily mean that all laws and requirements are harmonised, but that greater regulatory cooperation is made possible. Such approaches cut the so called “regulatory red tape” and allow for faster access by patients to quality, safe and efficient vaccines and treatments all around the globe.<br /><br /> </span> <p> </p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <span class="rte-heading">Related pages</span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <a href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-road-to-innovation/"><img id="__mcenew" src="/media/541103/screenshot-2020-04-21-at-152729.png" alt="" rel="13838" data-id="13838" /></a> <div style="text-align: center;"><span class="Subheading"><strong><a href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-road-to-innovation/"><br />Regulatory Road to Innovation<br /><br /></a></strong></span></div> </div> </div> <div class="col-md-4 column"> <div > <a data-id="12578" href="/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/" title="Clinical Trials"><img id="__mcenew" src="/media/412554/clinical-trials-pic-website.jpg" alt="" rel="12573" data-id="12573" /></a> <br /><br /> <div style="text-align: center;"><span class="Subheading"><a data-id="12578" href="/about-medicines/development-of-medicines/regulations-safety-supply/clinical-trials/" title="Clinical Trials">Clinical Trials</a></span></div> </div> </div> <div class="col-md-4 column"> <div > <a data-id="12619" href="/about-medicines/development-of-medicines/regulations-safety-supply/stimulating-the-development-of-new-medicines-for-children/" title="Stimulating the development of new medicines for children"><img id="__mcenew" src="/media/413560/pic-for-paediatric-page.png" alt="" rel="13611" data-id="13611" /></a> <br /><br /> <div style="text-align: center;"><span class="Subheading"><a data-id="12619" href="/about-medicines/development-of-medicines/regulations-safety-supply/stimulating-the-development-of-new-medicines-for-children/" target="_blank" title="Stimulating the development of new medicines for children">Stimulating the development of new medicines for children<br /><br /></a></span></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <a data-id="14209" href="/about-medicines/development-of-medicines/regulations-safety-supply/environment-health-safety-and-sustainability/" target="_blank" title="Environment, Health, Safety and Sustainability"><br /><img id="__mcenew" src="/media/25572/pie-website.jpg" alt="" rel="9306" data-id="9306" /></a> <a id=""></a><br /><br /> <div style="text-align: center;"><span class="Subheading"><a href="/about-medicines/development-of-medicines/regulations-safety-supply/environment-health-safety-and-sustainability/" target="_blank">Environment, Health, Safety and Sustainability</a></span></div> </div> </div> <div class="col-md-4 column"> <div > <br /><a data-id="12575" href="/about-medicines/development-of-medicines/regulations-safety-supply/innovative-pharmaceutical-manufacturing-ensuring-access-to-quality-medicines/" title="Annual Regulatory GMP/GDP Inspection Survey"><img id="__mcenew" src="/media/412555/manufacturing-pic-website.jpg" alt="" rel="12574" data-id="12574" /></a> <br /><br /> <div style="text-align: center;"><span class="Subheading"><a data-id="12575" href="/about-medicines/development-of-medicines/regulations-safety-supply/innovative-pharmaceutical-manufacturing-ensuring-access-to-quality-medicines/" title="Annual Regulatory GMP/GDP Inspection Survey">Technical Development and Manufacturing</a></span></div> </div> </div> <div class="col-md-4 column"> <div > <a data-id="9470" href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-affairs/" target="_blank" title="Regulatory Affairs"><br /><img id="__mcenew" src="/media/25824/reports-icon-website.jpg?width=342&height=92" alt="" width="342" height="92" rel="9593" data-id="9593" /></a> <br /><br /> <div style="text-align: center;"><span class="Subheading"><a data-id="9470" href="/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-affairs/" title="Regulatory Affairs">Regulatory Affairs</a></span></div> </div> </div> </div> </div> </div> </div> </div> </section> </div> <footer> <div class="pre-footer"> <div class="container"> <ul class="pre-footer__container"> <li class="pre-footer__items"> <a href="http://www.vaccineseurope.eu/" class="pre-footer__item-links "> <img src="/media/25325/vaccines-europe-new.png" alt="Vaccines Europe" /> </a> </li> <li class="pre-footer__items"> <a href="http://www.imi.europa.eu/" class="pre-footer__item-links "> <img src="/media/25326/imi-new.png" alt="IMI Europe" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.ethicalmedtech.eu/e4ethics/about-e4ethics/" class="pre-footer__item-links "> <img src="/media/25327/4ethics-new.png" alt="4 Ethics" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.emvo-medicines.eu/" class="pre-footer__item-links "> <img src="/media/25328/emvo-new.png" alt="EMVO" /> </a> </li> <li class="pre-footer__items"> <a href="http://www.ich.org/" class="pre-footer__item-links "> <img src="/media/288670/ich-logo.png" alt="ICH" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.ihi.europa.eu/" class="pre-footer__item-links "> <img src="/media/636696/ihi-logo.png" alt="IHI" /> </a> </li> </ul> </div> </div> <div class="footer-container"> <div class="footer__rights"> <span>EFPIA 2024 All rights reserved</span><br /> <a href="/privacy-notice/" class="disclaimer__link">Privacy Policy</a> - <a href="javascript: Cookiebot.renew()">Change your consent</a> </div> <div class="footer__disclaimer"> <div class="footer__social"> <a href="https://www.youtube.com/channel/UCSoatAirOLDiTiSVsCiLpCg" target="_blank"> <i class="fa fa-youtube-square fa-2x"></i> </a> <a href="https://twitter.com/efpia" target="_blank"> <i class="fa fa-square-x-twitter fa-2x"></i> </a> <a href="https://www.linkedin.com/company/efpia" target="_blank"> <i class="fa fa-linkedin-square fa-2x"></i> </a> </div> </div> </div> </footer> <footer class="footer__mobile"> <div class="pre-footer"> <ul class="pre-footer__container"> <li class="pre-footer__items"> <a href="http://www.vaccineseurope.eu/" class="pre-footer__item-links"> <img src="/media/25325/vaccines-europe-new.png" alt="Vaccines Europe" /> </a> </li> <li class="pre-footer__items"> <a href="http://www.imi.europa.eu/" class="pre-footer__item-links"> <img src="/media/25326/imi-new.png" alt="IMI Europe" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.ethicalmedtech.eu/e4ethics/about-e4ethics/" class="pre-footer__item-links"> <img src="/media/25327/4ethics-new.png" alt="4 Ethics" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.emvo-medicines.eu/" class="pre-footer__item-links"> <img src="/media/25328/emvo-new.png" alt="EMVO" /> </a> </li> <li class="pre-footer__items"> <a href="http://www.ich.org/" class="pre-footer__item-links"> <img src="/media/288670/ich-logo.png" alt="ICH" /> </a> </li> <li class="pre-footer__items"> <a href="https://www.ihi.europa.eu/" class="pre-footer__item-links"> <img src="/media/636696/ihi-logo.png" alt="IHI" /> </a> </li> </ul> </div> <div class="footer__social"> <a href="" target="_blank"> <i class="fa fa-google-plus-square fa-2x"></i> </a> <a href="https://www.youtube.com/channel/UCSoatAirOLDiTiSVsCiLpCg" target="_blank"> <i class="fa fa-youtube-square fa-2x"></i> </a> <a href="https://twitter.com/efpia" target="_blank"> <i class="fa fa-twitter-square fa-2x"></i> </a> <a href="https://www.linkedin.com/company/efpia" target="_blank"> <i class="fa fa-linkedin-square fa-2x"></i> </a> <a href="" target="_blank"> <i class="fa fa-pinterest-square fa-2x"></i> </a> </div> <div class="table"> <div class="footer__rights">EFPIA 2016-2023 All rights reserved</div> <div class="footer__disclaimer"> <a href="/privacy-notice/" class="disclaimer__link">Disclaimer</a> - <a href="#" class="disclaimer__link cookie-consent-settings">Change your consent</a> </div> </div> </footer> <script type="text/javascript"> _linkedin_partner_id = "653633"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id); </script><script type="text/javascript"> (function(){var s = document.getElementsByTagName("script")[0]; var b = document.createElement("script"); b.type = "text/javascript";b.async = true; b.src = "https://snap.licdn.com/li.lms-analytics/insight.min.js"; s.parentNode.insertBefore(b, s);})(); </script> <noscript> <img height="1" width="1" style="display:none;" alt="" src="https://dc.ads.linkedin.com/collect/?pid=653633&fmt=gif" /> </noscript> </section> <div class="overlay__mask"></div> <div class="search-overlay__mask"></div> <div class="popup__overlay"> <div class="popup__table-cell"> <div class="popup__content"> <h2> <span class="popup__heading"></span> <span class="popup__close icon-close"></span> </h2> <div class="popup__html"> </div> <div class="popup__buttons"> <div class="popup__button-left"> <a class="btn btn-primary popup__close">close</a> </div> <div class="popup__button-right"> <a class="btn btn--clear popup__continue no-popup" href="" target="_blank">continue</a> </div> </div> </div> </div> </div> </div> </div> <script src="/App/js/app.js?v=7052fdace13829e5ff0e7d49c99bc4f575eb526e"></script> <script type="text/javascript"> $(document).ready(function () { var siteKey = "6Lf_mSETAAAAAAf4wLjodHK-LtRmMgII-nxdpnqZ" stickyTab.init($(".section-navigation")); ; ; Navigation.init(); Header.init(); ArticleList.init(); }); $(window).load(function () { $("body").removeClass("notransition"); }); </script> <link rel="stylesheet" href="/css/image-map-pro.min.css"> <script src="/js/image-map-pro.min.js"></script> <script type="text/javascript"> ;(function ($, window, document, undefined) { $(document).ready(function() { $('#image-map-pro-container22').imageMapPro({"id":841,"editor":{"selected_shape":"spot-2477","transform_tooltip_mode":1,"tool":"select","shapeCounter":{"spots":10}},"general": {"name":"EFPIA-power-up","width":684,"height":674,"naturalWidth":684,"naturalHeight":674,"center_image_map":1}, "image":{"url":"https://efpia.eu/media/624966/efpia-powerup.jpg"}, "shapes":{"pageload_animation":"grow","glowing_shapes":1,"glow_opacity":0.4666666666666667},"tooltips":{"sticky_tooltips":1,"tooltip_animation":"grow"}, "layers":{"layers_list":[{"id":0,"title":"Main Floor","image_url":"https://efpia.eu/media/624927/powerupcover2021.jpg","image_width":684,"image_height":674}]}, "spots":[{"id":"spot-2723","title":"DIGITAL","x":45.23,"y":69.259,"width":135,"height":71,"x_image_background":45.23,"y_image_background":69.259,"static":1, "actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/digital-health/"}, "default_style":{"icon_type":"custom","icon_url":"https://efpia.eu/media/624964/efpia-powerup_0005_digital-health.png","icon_is_pin":0}, "tooltip_style":{"background_color":"#928b2d","auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-951661", "settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"DIGITAL HEALTH:<br>the power behind POWER"}, "style":{"background_color":"#928b2c"}}}]}}]}}},{"id":"spot-5902","title":"PEOPLE","x":24.973,"y":13.253,"width":108,"height":150,"x_image_background":24.973, "y_image_background":13.253,"static":1,"actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/people-centricity/"}, "default_style":{"border_radius":0,"background_type":"image","background_image_offset_y":-20,"background_opacity":0,"icon_type":"custom", "icon_url":"https://efpia.eu/media/624961/efpia-powerup_0002_people.png","icon_is_pin":0},"tooltip_style":{"background_color":"#f05270"}, "tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-823491","settings":{"elements":[{"settings":{"name":"Heading", "iconClass":"fa fa-header"},"options":{"heading":{"text":"PEOPLE-CENTRICITY:<br>the driving force"},"style":{"background_color":"#928b2c"}}}]}}]}}}, {"id":"spot-8681","title":"OUTCOMES","x":11.276,"y":63.398,"width":169,"height":139,"x_image_background":11.276,"y_image_background":63.398,"static":1, "actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/outcomes/"}, "default_style":{"icon_type":"custom","icon_url":"https://efpia.eu/media/624962/efpia-powerup_0003_outcomes.png","icon_is_pin":0}, "tooltip_style":{"background_color":"#99d6cc"}, "tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-840281","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"}, "options":{"heading":{"text":"OUTCOMES<br>matter most"},"style":{"background_color":"#928b2c"}}}]}}]}}},{"id":"spot-8700","title":"WORKFORCE","x":47.535,"y":83.393, "width":178,"height":140,"x_image_background":47.535,"y_image_background":83.393,"static":1,"actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/workforce/"}, "default_style":{"icon_type":"custom","icon_url":"https://efpia.eu/media/624959/efpia-powerup_0000_workforce.png","icon_is_pin":0},"tooltip_style":{"background_color":"#5c4087"}, "tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-795621","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"}, "options":{"heading":{"text":"WORKFORCE:<br>empowering the power base"},"style":{"background_color":"#928b2c"}}}]}}]}}}, {"id":"spot-202","title":"EFFICIENCY","x":84.416,"y":63.774,"width":172,"height":139,"x_image_background":84.416,"y_image_background":63.774,"static":1, "actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/efficiency/"},"default_style":{"icon_type":"custom", "icon_url":"https://efpia.eu/media/624965/efpia-powerup_0006_efficiency.png","icon_is_pin":0},"tooltip_style":{"background_color":"#145796"}, "tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-699641","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"}, "options":{"heading":{"text":"EFFICIENCY:<br>is imperative"},"style":{"background_color":"#928b2c"}}}]}}]}}},{"id":"spot-6615","title":"RESILIENCE", "x":77.201,"y":17.416,"width":152,"height":144,"x_image_background":77.201,"y_image_background":17.416,"static":1,"actions":{"click":"follow-link", "link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/resilience/"},"default_style":{"icon_type":"custom","icon_url":"https://efpia.eu/media/624960/efpia-powerup_0001_resilience.png", "icon_is_pin":0},"tooltip_style":{"background_color":"#a4c24d"},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-968171","settings":{"elements":[{"settings":{"name":"Heading", "iconClass":"fa fa-header"},"options":{"heading":{"text":"RESILIENCE:<br>future proofing<br>our health systems"},"style":{"background_color":"#928b2c"}}}]}}]}}}, {"id":"spot-2477","title":"INNOVATION","x":34.462,"y":62.521,"width":155,"height":50,"x_image_background":34.462,"y_image_background":62.521,"static":1, "actions":{"click":"follow-link","link":"https://efpia.eu/about-medicines/use-of-medicines/healthcare-systems/innovation/"},"default_style":{"icon_type":"custom", "icon_url":"https://efpia.eu/media/624963/efpia-powerup_0004_innovation.png","icon_is_pin":0},"tooltip_style":{"background_color":"#347e93"}, "tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-750481","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"}, "options":{"heading":{"text":"INNOVATION:<br>putting power tools to work"},"style":{"background_color":"#928b2c"}}}]}}]}}}]}); $('#image-map-pro-container0822').imageMapPro({"id":6937,"editor":{"previewMode":1,"selected_shape":"poly-1318","tool":"poly","shapeCounter":{"spots":1,"polys":4}},"general":{"name":"MTM INTRO","shortcode":"MTMINTRO","width":1900,"height":640,"naturalWidth":1900,"naturalHeight":640},"image":{"url":"https://efpia.eu/media/676542/efpia-new-medicine.png"},"spots":[{"id":"poly-7150","title":"improving-health","type":"poly","x":0,"y":38.138,"width":39.857,"height":61.862,"x_image_background":0,"y_image_background":38.138,"width_image_background":50.27563395810364,"height_image_background":71.02742557883131,"actions":{"click":"follow-link","link":"https://efpia.eu/more-than-medicine/improving-health/","open_link_in_new_window":0},"default_style":{"background_opacity":0},"tooltip_style":{"background_color":"F15171","width":192,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-361721","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"IMPROVING HEALTH","heading":"h2"}}},{"settings":{"name":"Paragraph","iconClass":"fa fa-paragraph"},"options":{"text":{"text":"Click to find out more"}}}]}}]}},"points":[{"x":0,"y":0.26455281533741665},{"x":71.64583857019846,"y":0},{"x":100,"y":54.23353210298403},{"x":89.07501907263153,"y":100},{"x":0,"y":100}]},{"id":"poly-7647","title":"turning-science","type":"poly","x":0,"y":0,"width":50.662,"height":69.639,"x_image_background":0,"y_image_background":0,"width_image_background":50.49614112458654,"height_image_background":57.28018191841235,"actions":{"click":"follow-link","link":"https://efpia.eu/more-than-medicine/turning-science-into-new-medicines/","open_link_in_new_window":0},"default_style":{"background_opacity":0},"tooltip_style":{"background_color":"9AC93C","width":342,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-285401","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"TURNING SCIENCE INTO NEW MEDECINES","heading":"h2"}}},{"settings":{"name":"Paragraph","iconClass":"fa fa-paragraph"},"options":{"text":{"text":"Click to find out more"}}}]}}]}},"points":[{"x":5.551115123125782e-17,"y":0},{"x":100,"y":0},{"x":99.89243767075861,"y":84.02023040863114},{"x":78.78138333621108,"y":100},{"x":56.47496930474715,"y":51.588594053665005},{"x":0,"y":51.8233044298998}]},{"id":"poly-149","title":"responsible-innovation","type":"poly","x":51.378,"y":0,"width":48.622,"height":70.458,"x_image_background":51.378,"y_image_background":0,"width_image_background":50.49614112458654,"height_image_background":57.28018191841235,"actions":{"click":"follow-link","link":"https://efpia.eu/more-than-medicine/responsible-innovation/","open_link_in_new_window":0},"default_style":{"background_opacity":0},"tooltip_style":{"background_color":"5C4188","width":238,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-936711","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"RESPONSIBLE INNOVATION","heading":"h2"}}},{"settings":{"name":"Paragraph","iconClass":"fa fa-paragraph"},"options":{"text":{"text":"Click to find out more"}}}]}}]}},"points":[{"x":0.45247007527456473,"y":0},{"x":99.9992471681618,"y":0},{"x":100,"y":54.2409222209569},{"x":44.105417409653455,"y":53.54430855629053},{"x":21.200572224759124,"y":100},{"x":0,"y":82.81022577277147}]},{"id":"poly-1318","title":"economic-impact","type":"poly","x":62.459,"y":39.852,"width":37.541,"height":60.148,"x_image_background":62.459,"y_image_background":39.852,"width_image_background":50.49614112458654,"height_image_background":57.28018191841235,"actions":{"click":"follow-link","link":"https://efpia.eu/more-than-medicine/economic-impact/","open_link_in_new_window":0},"default_style":{"background_opacity":0},"tooltip_style":{"background_color":"F5831E","width":186,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-525171","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"ECONOMIC IMPACT","heading":"h2"}}},{"settings":{"name":"Paragraph","iconClass":"fa fa-paragraph"},"options":{"text":{"text":"Click to find out more"}}}]}}]}},"points":[{"x":28.337018193441814,"y":0},{"x":100,"y":0.545321540200831},{"x":100,"y":100},{"x":9.986244513789437,"y":100},{"x":0,"y":53.199317097942675}]}]}); $('#image-map-pro-container').imageMapPro({"id":6762,"editor":{"tool":"select","shapeCounter":{"spots":4,"ovals":2}},"general":{"name":"EFPIA-MTM","width":616,"height":615,"naturalWidth":616,"naturalHeight":615},"image":{"url":"https://efpia.eu/media/676463/efpia-ethicalprinciples-base.jpg"},"shapes":{"pageload_animation":"grow","glowing_shapes":1},"spots":[{"id":"oval-5315","title":"integrity","type":"oval","x":73.297,"y":39.838,"width":20.942,"height":20.976,"x_image_background":73.297,"y_image_background":39.838,"width_image_background":20.942,"height_image_background":20.976,"static":1,"default_style":{"background_type":"image","background_image_url":"https://efpia.eu/media/676464/efpia-ethicalprinciples-integrity.png"},"mouseover_style":{"background_image_url":"https://efpia.eu/media/676464/efpia-ethicalprinciples-integrity.png"},"tooltip_style":{"background_color":"#537bbd","width":314,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-435101","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"We act with INTEGRITY, interact in a responsible manner and aim to ensure that our communications with stakeholders are accurate, legitimate and balanced. We are accountable for our decisions, actions and interactions and we encourage others to follow the same high ethical standards."},"layout":{"use_grid":0,"width":300},"style":{"background_color":"#537bbd"},"font":{"font_family":"lato"}}}]}}]}}},{"id":"oval-3447","title":"transparency","type":"oval","x":4.952,"y":40.488,"width":20.942,"height":20.976,"x_image_background":4.952,"y_image_background":40.488,"width_image_background":20.942,"height_image_background":20.976,"static":1,"default_style":{"background_type":"image","background_image_url":"https://efpia.eu/media/676467/efpia-ethicalprinciples-transparency.png"},"mouseover_style":{"background_image_url":"https://efpia.eu/media/676467/efpia-ethicalprinciples-transparency.png"},"tooltip_style":{"background_color":"#138798","width":332,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-857991","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"We are committed to ensure that TRANSPARENCY is respected. We are open about our activities and interactions and encourage stakeholders to act with the same openness."},"layout":{"use_grid":0,"width":300},"style":{"background_color":"#138798"},"font":{"font_family":"lato"}}}]}}]}}},{"id":"oval-8283","title":"respect","type":"oval","x":39.693,"y":73.497,"width":20.942,"height":20.976,"x_image_background":39.693,"y_image_background":73.497,"width_image_background":20.942,"height_image_background":20.976,"static":1,"default_style":{"background_type":"image","background_image_url":"https://efpia.eu/media/676466/efpia-ethicalprinciples-respect.png"},"mouseover_style":{"background_image_url":"https://efpia.eu/media/676466/efpia-ethicalprinciples-respect.png"},"tooltip_style":{"background_color":"#1e5595","width":428,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-968971","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"We interact with all our stakeholders with RESPECT. We commit to approach our stakeholders in an open manner, with a responsive, constructive and learning attitude and mutual respect. We value the importance of independent decision-making by stakeholders, based on evidence and including patient interest. With respect to society, we listen to what is expected from us and adapt our way of working accordingly. We follow applicable laws and make ethical judgements when processing Personal Health Data."},"layout":{"use_grid":0,"width":300},"style":{"background_color":"#537bbd"},"font":{"font_family":"lato"}}}]}}]}}},{"id":"oval-7074","title":"patientsfirst","type":"oval","x":39.53,"y":5.041,"width":20.942,"height":20.976,"x_image_background":39.53,"y_image_background":5.041,"width_image_background":20.942,"height_image_background":20.976,"static":1,"default_style":{"background_type":"image","background_image_url":"https://efpia.eu/media/676465/efpia-ethicalprinciples-patientsfirst.png"},"mouseover_style":{"background_image_url":"https://efpia.eu/media/676465/efpia-ethicalprinciples-patientsfirst.png"},"tooltip_style":{"background_color":"#97c340","width":372,"auto_width":0},"tooltip_content":{"squares_settings":{"containers":[{"id":"sq-container-743751","settings":{"elements":[{"settings":{"name":"Heading","iconClass":"fa fa-header"},"options":{"heading":{"text":"First and foremost, the PATIENTS ARE AT THE HEART OF WHAT WE DO. We aspire to ensure that everything we do will ultimately benefit patients. Our primary contribution to society is to make high quality Medicinal Products and to encourage their appropriate and rational use in the care pathway."},"layout":{"use_grid":0,"width":300},"style":{"background_color":"#537bbd"},"font":{"font_family":"lato"}}}]}}]}}}]}); }); })(jQuery, window, document); </script> <script type="text/javascript"> _linkedin_partner_id = "3968705"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id); </script><script type="text/javascript"> (function(l) { if (!l){window.lintrk = function(a,b){window.lintrk.q.push([a,b])}; window.lintrk.q=[]} var s = document.getElementsByTagName("script")[0]; var b = document.createElement("script"); b.type = "text/javascript";b.async = true; b.src = "https://snap.licdn.com/li.lms-analytics/insight.min.js"; s.parentNode.insertBefore(b, s);})(window.lintrk); </script> <noscript> <img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=3968705&fmt=gif" /> </noscript>  <script> !function(e,t,n,s,u,a){e.twq||(s=e.twq=function(){s.exe?s.exe.apply(s,arguments):s.queue.push(arguments); },s.version='1.1',s.queue=[],u=t.createElement(n),u.async=!0,u.src='//static.ads-twitter.com/uwt.js', a=t.getElementsByTagName(n)[0],a.parentNode.insertBefore(u,a))}(window,document,'script'); // Insert Twitter Pixel ID and Standard Event data below twq('init','o6yg9'); twq('track','PageView'); </script>   </body> </html>

CINXE.COM

Regulations, safety & supply