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How the committees work | European Medicines Agency (EMA)

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href="/en/homepage">Home</a></li><li class="breadcrumb-item" ><a href="https://www.ema.europa.eu/en/committees"><svg class="d-md-none ms-0 me-2 me-2-5 bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#arrow-left"/></svg>Committees, working parties and other groups</a></li><li class="breadcrumb-item d-none d-md-block active" aria-current="page" >How the committees work</li></ol></nav></div></div></header><main id="main-content" class="main-content-wrapper" role="main" aria-label="Main content"><div class="container mt-3"><div class="row"><div class="col-12"><div data-drupal-messages-fallback class="hidden"></div><div id="block-ema-content-banner--2"><div class="node ema-general content-banner ema-general--content-banner mb-4-75 bcl-content-banner ema-light-blue"><div class="container px-0"><div class="row"><div class="col-12"><article class="bg-transparent border-0 card container"><div class="row"><div class="right-col"><div class="card-body container"><div class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>How the committees work</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><div class="ema-social-media-share button"><script type="application/json">{"service":"share","version":"2.0","more":["email","linkedin","bluesky","facebook","whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"selection":true,"stats":true,"target":"_blank"}</script></div></div></div><div class="card-content-block"><div class="card-content-wrapper"><div class="content"><div class="field string-long ema-general__field-ema-summary">The European Medicines Agency (EMA) has seven scientific committees and a number of working parties and related groups which conduct the scientific work of the Agency.</div></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-3 align-items-start"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Veterinary"><span class="label">Veterinary</span></span></div></div></div></div></div></div></div></div></article></div></div></div></div></div></div><div class="col-12 "><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><article class="content-with-sidebar node ema-general ema-general--full container"><div class="row"><div class="bcl-sidebar col-md-3"><nav class="bcl-inpage-navigation position-sticky" id="bcl-inpage-navigation"><h2 class="mb-0 dropdown-toggle bcl-heading" aria-expanded="false" type="button" id="bcl-inpage-navigation-dropdown" data-bs-toggle="dropdown"> Page contents<svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#chevron-down"/></svg></h2><div class="dropdown-menu" role="navigation" aria-labelledby="bcl-inpage-navigation-dropdown"><ul class="nav nav-pills flex-column" ><li class="nav-item" ><a class="nav-link" href="#emas-committees-62972">EMA's committees</a></li><li class="nav-item" ><a class="nav-link" href="#composition-of-committees-and-working-parties-62973">Composition of committees and working parties</a></li><li class="nav-item" ><a class="nav-link" href="#adopting-a-committee-opinion-or-recommendation-62974">Adopting a committee opinion or recommendation</a></li><li class="nav-item" ><a class="nav-link" href="#what-we-publish-62975">What we publish</a></li><li class="nav-item" ><a class="nav-link" href="#related-content-17301">Related content</a></li><li class="nav-item" ><a class="nav-link" href="#related-documents-17302">Related documents</a></li></ul></div></nav></div><div class="col-md-9"><div class="ema-node-content-wrapper node-sections"><div class="item"><div id="ema-inpage-item-10314" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>The committee's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the <a href="/en/about-us/what-we-do/authorisation-medicines">authorisation of medicines</a> in Europe.</p><p>The committees and <a href="/en/committes/working-parties-other-groups">working parties</a> also contribute to the <strong>development of medicines</strong> and medicine regulation, by:</p><ul><li>providing scientific advice to companies researching and developing new medicines;</li><li>preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications;</li><li>contributing to the harmonisation of regulatory requirements n the EU and internationally.</li></ul><p>For more information, see <a href="/en/about-us/what-we-do">What we do</a>.</p></div></div></div><div class="item"><div id="ema-inpage-item-62972" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="emas-committees-62972"><h2 class="mb-4 rounded-title"> EMA&#039;s committees </h2></div><div class="ecl-editor"><ul><li><a href="https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp">Committee for Medicinal Products for Human Use (CHMP)</a></li><li><a href="/en/committees/pharmacovigilance-risk-assessment-committee-prac" data-entity-type="node" data-entity-uuid="ee744cb2-f0b7-4c35-ab17-719aade5b652" data-entity-substitution="canonical" title="Pharmacovigilance Risk Assessment Committee (PRAC)">Pharmacovigilance Risk Assessment Committee (PRAC)</a></li><li><a href="/en/committees/committee-veterinary-medicinal-products-cvmp" data-entity-type="node" data-entity-uuid="c9f8ab45-4376-44e5-9371-94b6cd1e4bfc" data-entity-substitution="canonical" title="Committee for Veterinary Medicinal Products (CVMP)">Committee for Medicinal Products for Veterinary Use (CVMP)</a></li><li><a href="/en/committees/committee-orphan-medicinal-products-comp" data-entity-type="node" data-entity-uuid="c4195fb4-7f01-40c4-afbf-5010acdce536" data-entity-substitution="canonical" title="Committee for Orphan Medicinal Products (COMP) ">Committee for Orphan Medicinal Products (COMP)</a></li><li><a href="/en/committees/committee-herbal-medicinal-products-hmpc" data-entity-type="node" data-entity-uuid="cca5928e-2c6a-4a35-9b22-631b266c4d3f" data-entity-substitution="canonical" title="Committee on Herbal Medicinal Products (HMPC)">Committee on Herbal Medicinal Products (HMPC)</a></li><li><a href="/en/committees/committee-advanced-therapies-cat" data-entity-type="node" data-entity-uuid="8eb51114-f661-4eaf-9744-135706d0d453" data-entity-substitution="canonical" title="Committee for Advanced Therapies (CAT)">Committee for Advanced Therapies (CAT)</a></li><li><a href="/en/committees/paediatric-committee-pdco" data-entity-type="node" data-entity-uuid="9cdc6328-e0ea-4f4c-ba3b-5d84e3ff60fa" data-entity-substitution="canonical" title="Paediatric Committee (PDCO)">Paediatric Committee (PDCO)</a></li></ul></div></div></div><div class="item"><div id="ema-inpage-item-62973" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="composition-of-committees-and-working-parties-62973"><h2 class="mb-4 rounded-title"> Composition of committees and working parties </h2></div><div class="ecl-editor"><p>EMA's committees, working parties and related groups are composed of <a href="/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts/">European experts</a> made available by national competent authorities of the EU and EEA <a href="/en/partners-networks/eu-partners/eu-member-states">Member States</a>.</p><p>For a list of national competent authorities in the EEA, see:</p><ul><li><a href="/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human">National competent authorities (human)</a></li><li><a href="/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-veterinary">National competent authorities (veterinary)</a></li></ul><p>The Agency maintains a public <a href="/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts/">European expert list</a> on all experts who can be involved in EMA work. Experts can only be involved once the Agency has assessed their <a href="/en/about-us/how-we-work/handling-competing-interests">declaration of interests</a>.</p></div></div></div><div class="item"><div id="ema-inpage-item-62974" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="adopting-a-committee-opinion-or-recommendation-62974"><h2 class="mb-4 rounded-title"> Adopting a committee opinion or recommendation </h2></div><div class="ecl-editor"><p>EMA committees each have their own rules of procedure. To carry out a scientific assessment, usually a committee appoints a <strong>rapporteur</strong> to prepare an assessment report, which the committee will consider and eventually adopt as part of a scientific opinion or recommendation. For certain procedures, a 'co-rapporteur' also prepares an assessment independently from the rapporteur.</p><p>An <strong>assessment team</strong> supports the rapporteur and co-rapporteur with necessary expertise and resources. The EMA secretariat provides technical, scientific and administrative support for each assessment.</p><p>Rapporteurs and co-rapporteurs can establish <strong>multinational assessment teams</strong> by including experts from other Member States as well as their own. This is intended to mobilise the best expertise for medicines evaluation regardless of where experts are geographically based. For more information, see <a href="/en/about-us/how-we-work/european-medicines-regulatory-network">European medicines regulatory network</a>.</p><p>A <strong>peer-review process</strong> provides additional quality assurance of certain scientific assessments.</p><p>EMA committees try to reach their conclusions by <strong>consensus</strong> whenever possible, but if not the committee holds a <strong>vote. </strong>For more information, please refer to the below document:</p><div class="mt-4 ema-file-wrapper" xmlns:xlink="http://www.w3.org/1999/xlink"><div data-ema-document-type="regulatory-procedural-guideline" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf" /></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Guidance document on voting in the framework of discussion and adoption of CHMP opinions</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">CPMP/3137/01 Rev 2</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (185.15 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2008-06-01T00:00:00Z">01/06/2008</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-07-26T09:24:00Z">26/07/2023</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/regulatory-procedural-guideline/guidance-document-voting-framework-discussion-and-adoption-chmp-opinions_en.pdf">View<svg class="ms-2-5 bi icon--fluid"><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye" /></svg></a></div></div></div><p>EMA may exclude committee members from voting on specific issues, in line with EMA 's policy on <a href="/en/about-us/how-we-work/handling-competing-interests">Handling competing interests</a>.</p><p>The working language of all of the EMA committees is English. This includes plenary discussions, working documents and correspondence. EMA does not provide interpretation and translation services.</p><p>For more information, see the individual committees' 'Rules of procedure' available on their webpage.</p><p>EMA financially remunerates the national authorities for certain types of work carried out by their staff on behalf of the EMA committees (e.g. as rapporteurs or experts), in the framework of <a href="/en/human-regulatory/overview/fees-payable-european-medicines-agency">Fees payable to EMA</a>.</p></div></div></div><div class="item"><div id="ema-inpage-item-62975" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div id="what-we-publish-62975"><h2 class="mb-4 rounded-title"> What we publish </h2></div><div class="ecl-editor"><p>EMA publishes the <strong>dates, agendas, minutes and outcomes </strong>of committee meetings on its website.聽Please find a list of abbreviations commonly used the Agency鈥檚 human medicines scientific committees and CMDh documents, including the agendas, minutes and outcomes of committee meetings:</p></div></div></div><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--default" id="ema-inpage-item-62955"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA鈥檚 regulatory activities</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/899164/2022</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (434.08 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2012-10-05T11:59:00Z">05/10/2012</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2024-12-02T11:12:00Z">02/12/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/abbreviations-used-ema-scientific-committees-cmd-documents-relation-emas-regulatory-activities_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div></div></div><div class="item"><div id="ema-inpage-item-62976" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--default"><div class="ecl-editor"><p>EMA publishes the <strong>dates, agendas, minutes and outcomes </strong>of committee meetings on its website.聽Please find a list of abbreviations commonly used the Agency鈥檚 human medicines scientific committees and CMDh documents, including the agendas, minutes and outcomes of committee meetings:</p><p>In addition, EMA publishes information on the medicines evaluated by its scientific committees at various stages of the regulatory process, including <strong>public versions of scientific assessment reports </strong>and<strong> public-friendly information</strong> for non-experts.</p><p>For more information, see:</p><ul><li><a href="/en/about-us/how-we-work/transparency">Transparency</a></li><li><a href="/en/medicines/what-we-publish-medicines-when">What we publish on medicines and when</a></li><li><a href="/medicines/field_ema_web_categories%25253Aname_field/Human/ema_group_types/ema_medicine">Search human medicines</a></li><li><a href="/medicines/ema_group_types/ema_medicine/field_ema_web_categories%253Aname_field/Veterinary">Search veterinary medicines</a></li></ul></div></div></div><div class="item"><div class="related-section-wrapper" id="ema-inpage-item-17301"><h4 id="related-content-17301" class="rounded-title d-flex align-items-center p-2 mb-3"><span class="title flex-grow-1"> Related content </span><span class="icon"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#"/></svg></span></h4><div class="item"><div id="ema-inpage-item-14678" class="paragraph paragraph--type--oe-rich-text paragraph--view-mode--related-section"><div class="ecl-editor"><ul><li><a href="/en/about-us/what-we-do/legal-framework">Legal foundation</a></li><li><a href="/en/about-us/how-we-work/european-medicines-regulatory-network/european-experts/">European experts</a></li><li><a href="/en/about-us/how-we-work/european-medicines-regulatory-network">European medicines regulatory network</a></li><li><a href="/en/about-us/how-we-work/transparency">Transparency</a></li><li><a href="/en/about-us/how-we-work/handling-competing-interests">Handling competing interests</a></li><li><a href="/en/medicines/what-we-publish-medicines-when">What we publish on medicines and when</a></li></ul></div></div></div></div></div><div class="item"><div class="related-section-wrapper" id="ema-inpage-item-17302"><h4 id="related-documents-17302" class="rounded-title d-flex align-items-center p-2 mb-3"><span class="title flex-grow-1"> Related documents </span><span class="icon"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#"/></svg></span></h4><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--related-section" id="ema-inpage-item-17002"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="other" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Principles for publication of agendas and minutes of EMA scientific committees</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/555647/2013</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (100.02 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2013-12-18T12:00:00Z">18/12/2013</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2013-12-18T12:00:00Z">18/12/2013</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/other/principles-publication-agendas-and-minutes-ema-scientific-committees_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#eye"/></svg></a></div></div></div><div id="related-documents-17002" class="ema-container-empty"></div></div></div></div></div><div class="ema-social-media-share inline mb-4"><h2>Share this page</h2><script type="application/json">{"service":"share","version":"2.0","networks":["email","linkedin","bluesky","facebook","more"],"more":["whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"target":"_blank","stats":true,"selection":true}</script></div></div></div></div><div class="rate-widget fivestar"><form 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