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<!DOCTYPE html> <html text> <head> <meta charset="utf-8">  <link rel="icon" href="/_assets/4092b61796a70c92e09b6164764c5e27/Icons/favicon.ico" type="image/vnd.microsoft.icon"> <title>Heads of Medicines Agencies: EU-Innovation Network (EU-IN)</title> <meta http-equiv="x-ua-compatible" content="IE=edge"> <meta name="generator" content="TYPO3 CMS"> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta name="twitter:card" content="summary"> <link rel="stylesheet" href="/typo3temp/assets/compressed/merged-ad7f08607b1a91f71c9cdb17a03b70c3.css?1736865731" media="all"> <link rel="stylesheet" href="/typo3temp/assets/compressed/merged-baf9ab3f79982ebd83710215ff8a6ddf.css?1721117883" media="screen,projection"> <link rel="stylesheet" href="/typo3temp/assets/compressed/merged-4b1194b923a5e1e8ae5572a65c344406.css?1721117883" media="print"> <meta http-equiv="X-UA-Compatible" content="IE=edge,chrome=1"> <link rel="canonical" href="https://www.hma.eu/about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html"> </head> <body> <div class="container"><header id="header" role="banner"><a href="/about-hma.html"><img src="/fileadmin/dateien/logo.png" alt="HMA - Heads of Medicines Agencies" id="logo" width="209" height="122"></a><div class="right"><nav id="service-nav" role="navigation"><ul><li><a href="/rss.html"><span class="icon-rss"></span>RSS</a></li><li><a href="/sitemap.html">Sitemap</a></li><li><a href="http://sp.hma.eu" target="_blank" rel="noreferrer">Login (HMA-DMS)</a></li><li><a href="/contact.html">Contact</a></li></ul></nav><div class="tx_solr container"><div class="row"><div class="col-md-12"><div class="tx-solr-search-form identifier143"><form method="get" class="search" id="tx-solr-search-form-pi-results" action="/search.html" data-suggest="/search?type=7384" data-suggest-header="Top Results" accept-charset="utf-8"><div class="input-group"><input type="text" class="tx-solr-q js-solr-q tx-solr-suggest tx-solr-suggest-focus form-control" placeholder="Search" name="tx_solr[q]" value=""><span class="input-group-btn"><button class="btn btn-default tx-solr-submit" type="submit"><span class=" glyphicon glyphicon-search"></span><span> Search </span></button></span></div></form></div></div></div></div></div><nav id="main-nav" role="navigation"><ul><li class="active"><a href="/about-hma.html">About HMA</a></li><li><a href="/human-medicines.html">Human Medicines</a></li><li><a href="/veterinary-medicines.html">Veterinary Medicines</a></li></ul></nav></header><div id="main" class="page-home" role="main"><ul class="breadcrumb"><li>You are here:</li><li><a href="/">Home</a></li><li>><a href="/about-hma.html">About HMA</a></li><li>><a href="/about-hma/working-groups.html">Working Groups</a></li><li>><a href="/about-hma/working-groups/eu-innovation-network-eu-in.html">EU-Innovation Network (EU-IN)</a></li></ul><nav id="sub-nav"><ul><li><a href="/about-hma/vision-and-mission.html">Vision and mission</a></li><li><a href="/about-hma/structure.html">Structure</a></li><li class="active"><a href="/about-hma/working-groups.html">Working Groups</a><ul><li><a href="/about-hma/working-groups/benchmarking-of-european-medicines-agencies.html">Benchmarking of European Medicines Agencies (BEMA)</a></li><li><a href="/about-hma/working-groups/eu-network-pharmacovigilance-oversight-group.html">EU Network Pharmacovigilance Oversight Group</a></li><li><a href="/about-hma/working-groups/eu-network-training-centre-eu-ntc-former-otsg.html">EU Network Training Centre (EU-NTC) - former OTSG</a></li><li class="active"><a href="/about-hma/working-groups/eu-innovation-network-eu-in.html">EU-Innovation Network (EU-IN)</a></li><li><a href="/about-hma/working-groups/hma/ema-joint-big-data-steering-group.html">HMA/EMA Joint Big Data Steering Group</a></li><li><a href="/about-hma/working-groups/hma-substances-validation-group.html">HMA Substances Validation Group</a></li><li><a href="/about-hma/working-groups/hma/ema-joint-task-force-on-availability-of-authorised-medicines-for-human-and-veterinary-use-tf-aam.html">HMA/EMA Joint Task Force on Availability of authorised medicines for human and veterinary use (TF AAM)</a></li><li><a href="/about-hma/working-groups/hma/ema-joint-audit-programme-jap.html">HMA/EMA Joint Audit Programme (JAP)</a></li><li><a href="/about-hma/working-groups/telematics.html">Telematics</a></li><li><a href="/about-hma/working-groups/hma-working-group-of-biosimilars.html">HMA Working Group of Biosimilars (BSWG)</a></li><li><a href="/about-hma/working-groups/working-group-of-communication-professionals.html">Working Group of Communication Professionals</a></li><li><a href="/about-hma/working-groups/working-group-of-enforcement-officers.html">Working Group of Enforcement Officers</a></li><li><a href="/about-hma/working-groups/hma-working-group-of-quality-managers.html">HMA Working Group of Quality Managers</a></li><li><a href="/about-hma/working-groups/european-medicines-agencies-co-operation-of-legal-and-legislative-issues-emacolex.html">European Medicines Agencies Co-operation of Legal and Legislative Issues (EMACOLEX)</a></li><li><a href="/about-hma/working-groups/clinical-trials-coordination-group.html">Clinical Trials Coordination Group</a></li><li><a href="/about-hma/working-groups/homeopathic-medicinal-products-working-group.html">Homeopathic Medicinal Products Working Group</a></li><li><a href="/about-hma/working-groups/periodic-safety-update-reporting-psur-synchronisation-and-work-sharing.html">Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing</a></li><li><a href="/about-hma/working-groups/regulatory-optimisation-group-rog.html">Regulatory Optimisation Group (ROG)</a></li><li><a href="/about-hma/working-groups/hma-core-group-for-medical-devices.html">HMA Core Group for Medical Devices</a></li></ul></li><li><a href="/about-hma/national-contacts.html">National Contacts</a></li><li><a href="/about-hma/covid-19.html">COVID-19</a></li><li><a href="/about-hma/combination-products.html">Combination products</a></li><li><a href="/about-hma/transparency.html">Transparency</a></li><li><a href="/about-hma/meetings.html">Meetings</a></li><li><a href="/about-hma/medicines-approval-system.html">Medicines Approval system</a></li><li><a href="/about-hma/publications-and-reports.html">Publications and reports</a></li><li><a href="/about-hma/recently-published.html">Recently Published</a></li></ul></nav><div class="content"><div class="service"><span class="icon-hma-active"></span><p class="icons"> </p></div><div id="c5500" class="frame frame-default frame-type-text frame-layout-0"><p><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2025_01_EU_IN_Workplan_2025.pdf">EU-Innovation Network Workplan 2025</a> | pdf</p><p><br><strong>Introduction and Overview</strong></p><p>One of the <abbr title="Heads of Medicines Agencies" lang="">HMA</abbr> strategic goals is to foster research and the uptake of innovative methods in the development of medicines. This helps to make safe and effective innovative medicines available to patients in a timely manner. The priority Innovation is listed in the Multi-Annual Work Plan of the <abbr title="Heads of Medicines Agencies" lang="">HMA</abbr> in which the <acronym title="European Union" lang="">EU</acronym> IN plays a vital role.</p><p>In order to ensure access to new medicines for patients it is essential for Europe to have a regulatory environment that understands and facilitates innovation. The Agency and the European medicines regulatory network support the development of innovative methodologies by fostering greater collaboration across the regulatory network and especially the National Competent Authorities with academia.</p><p>Innovation offices in national regulatory agencies have been working informally with the <acronym title="European Medicines Agency" lang="">EMA</acronym>'s Innovation Task Force (ITF) on matters relating to emerging therapies and technologies since 2011.</p><p>The <acronym title="European Union" lang="">EU</acronym> Innovation Network (<acronym title="European Union" lang="">EU</acronym>-IN) was established in 2015 to strengthen the collaboration between national competent authorities (<acronym title="National Competent Authorities" lang="">NCAs</acronym>) and the European Medicines Agency (<acronym title="European Medicines Agency" lang="">EMA</acronym>) on regulatory matters relating to emerging therapies and technologies. Its objective is to facilitate the development of innovative medicines and associated technologies by addressing gaps in early regulatory support, providing a platform to share good practices and strengthening engagement with innovators. It is comprised of representatives from innovation offices within <acronym title="National Competent Authorities" lang="">NCAs</acronym> and EMA’s Innovation Task Force (ITF).</p><p>The <acronym title="European Union" lang="">EU</acronym> Innovation Network has a joint mandate from both the Heads of Medicines Agencies (<abbr title="Heads of Medicines Agencies" lang="">HMA</abbr>) and <acronym title="European Medicines Agency" lang="">EMA</acronym> (renewed 2020):</p><ul><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2025_01_Mandate_European_Innovation_network.pdf">Mandate of the European Innovation Network</a> (January 2025)</li></ul><p>The aim of the network is to improve and make the regulatory support for medicines developers currently available at national and <acronym title="European Union" lang="">EU</acronym> levels more visible and attractive to innovators, in particular by:</p><ul><li>sharing experience and knowledge by discussing case-studies, with sponsor agreement, to identify challenges for emerging innovation and leading experts in innovative fields, where appropriate;</li><li>contributing to consolidating an <acronym title="European Union" lang="">EU</acronym> expert view on topics relevant to the regulation of innovative therapies and technologies through collaboration with other relevant groups such as the Clinical Trials Facilitation Group (<abbr title="Clinical Trial Facilitation Group" lang="">CTFG</abbr>), <a href="https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/scientific-advice-working-party" target="_blank" rel="noreferrer">Scientific Advice Working Party</a> (SAWP), Health Technology Assessment (HTA) Bodies;</li><li>implementing specific initiatives to raise awareness of and strengthen the supports available for innovators;</li><li>supporting the <a href="/about-hma/working-groups/eu-network-training-centre-eu-ntc-former-otsg.html" target="_blank">EU network training centre</a> (<acronym title="European Union" lang="">EU</acronym>-NTC) by identifying training needs in the regulatory network;</li><li>facilitating the establishment of innovation offices in other regulatory agencies through sharing best practice;</li><li>identifying, through horizon scanning, emerging trends that may require regulatory guidance and support by the European medicines regulatory network;</li><li>discussing and sharing opinions on borderline classification issues from a medicinal products perspective and collaborating with other groups on such issues as appropriate;</li><li>promoting Heads of Medicines Agencies (HMAs) collaboration in the Innovative Medicines Initiative (IMI) projects and other <acronym title="European Union" lang="">EU</acronym> funded schemes.</li></ul></div><div id="c6786" class="frame frame-default frame-type-textpic frame-layout-0"><div class="ce-textpic ce-center ce-above"><div class="ce-bodytext"><p><strong>Strengthening Training of Academia in Regulatory Science (STARS)</strong></p><p>The <a href="https://www.csa-stars.eu/index.html" target="_blank" rel="noreferrer">EU-funded<sup>1</sup> Coordination and Support Action (CSA) on the Strengthening Training of Academia in Regulatory Science</a> (STARS) is a collaboration between 18 European National Competent Authorities (<acronym title="National Competent Authorities" lang="">NCAs</acronym>/<acronym title="European Union" lang="">EU</acronym> IN members), four associate countries and the <a href="http://www.ema.europa.eu/" target="_blank" rel="noreferrer">European Medicines Agency</a> (<acronym title="European Medicines Agency" lang="">EMA</acronym>).</p><p>The project aims to reach out to medicine innovators in academia, to bridge the regulatory knowledge gap, and enhance the dialogue between academia and regulatory authorities.</p><blockquote><p><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/STARS_project_main_goals.png" target="_blank">STARS project main goals and involved member states </a></p></blockquote><p><sub>Light green: STARS partner, dark green: associated STARS partner; <a href="https://www.sciencedirect.com/science/article/pii/S1359644620304347?via%3Dihub#!" target="_blank" rel="noreferrer">Starokozhko et al., 2020</a></sub></p><p>The STARS project has developed an online <a href="https://www.csa-stars.eu/Inventory-1721.html" target="_blank" rel="noreferrer">Comprehensive Inventory</a> that assists European academic drug developers in finding various support services provided by <acronym title="National Competent Authorities" lang="">NCAs</acronym>, public actors and private entities. STARS has also initiated three <a href="https://www.csa-stars.eu/Pilot-Projects-1694.html" target="_blank" rel="noreferrer">pilot support activities</a>, which aim to transfer best practices and to close gaps in regulatory knowledge and support that have been identified by performing systematic surveys of clinical research centres, research groups, funding bodies and <acronym title="National Competent Authorities" lang="">NCAs</acronym>.</p><blockquote><p><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/STARS_Working_programme.png" target="_blank">STARS Working programme</a></p></blockquote><p><sub>The project pursues different activities, all of which aim to improve the regulatory knowledge and success of academic medical research.</sub></p><p>The STARS consortium is developing <a href="https://www.csa-stars.eu/STARS-Curricula-1682.html" target="_blank" rel="noreferrer">curricula</a> for training and education in regulatory knowledge, requirements and affairs. All of these activities are supported by communication and dissemination strategies, such as <a href="https://www.csa-stars.eu/First-European-Stakeholder-Workshop-1739.html" target="_blank" rel="noreferrer">Stakeholder Workshops</a> and a global conference, which will take place at the end of the project in June 2022.</p><p>Finally, the results and insights from the STARS activities are to be integrated into the <a href="https://www.csa-stars.eu/Strategy-1724.html" target="_blank" rel="noreferrer">STARS Common Strategy</a>, which is the main roadmap to strengthening regulatory science and which aims to improve the support and optimise the outcomes of scientific advice and protocol assistance.</p><p>Further information and contact details are available on the <a href="https://www.csa-stars.eu" target="_blank" rel="noreferrer">STARS website</a>.</p><p> </p><hr><p><sup>1</sup><sub>This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825881</sub></p></div></div></div><div id="c7162" class="frame frame-default frame-type-textpic frame-layout-0"><div class="ce-textpic ce-center ce-above"><div class="ce-bodytext"><p><strong>Involvement of competent authorities in externally funded projects</strong></p><p>As part of its mandate, the <acronym title="European Union" lang="">EU</acronym>-IN is tasked with promoting the involvement and collaboration of competent authorities in relevant externally-funded projects. With this in mind, the <acronym title="European Union" lang="">EU</acronym>-IN has prepared guidance for researchers and project teams in relation to the circumstances in which competent authorities would consider involvement in externally funded research projects related to medicinal products. The guidance also outlines the information that should be provided to the competent authority when requesting their involvement in such a project. Any existing position / guidance that an individual competent authority may have in place in relation to such requests should also be considered.<br>  </p><ul><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2023_02_EU-IN_Involvement_of_competent_authorities_in_externally_funded_projects.pdf">Involvement of competent authorities in externally funded projects</a></li></ul></div></div></div><div id="c6787" class="frame frame-default frame-type-textpic frame-layout-0"><div class="ce-textpic ce-center ce-above"><div class="ce-bodytext"><p><strong>Simultaneous National Scientific Advice (SNSA)</strong></p><p>The <acronym title="European Union" lang="">EU</acronym> Innovation Network (<acronym title="European Union" lang="">EU</acronym> IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot. SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one <acronym title="National Competent Authority" lang="">NCA</acronym> at the same time. The format is intended to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicine Agencies (<abbr title="Heads of Medicines Agencies" lang="">HMA</abbr>), phase 2 of the SNSA pilot will run for a two-year period until the end of 2024. Phase 2 incorporates an optimised procedure intended to maximise the benefits for both applicants and competent authorities.</p><p>In conjunction with the <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines#accelerating-clinical-trials-in-the-eu-(act-eu)-section" target="_blank" rel="noreferrer">ACT-EU initiative</a>, this phase of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. It will facilitate sponsors / developers to obtain clinical trial-related national scientific advice from National Competent Authorities (<acronym title="National Competent Authority" lang="">NCA</acronym>) in Member States (MS) where they intend to perform clinical trials. The experience gained during the SNSA pilot will be used to further develop the process and the provision of clinical trial-related advice as part of ACT <acronym title="European Union" lang="">EU</acronym> Priority Action 7 (ACT <acronym title="European Union" lang="">EU</acronym> PA7). The following are examples of scenarios where developers may choose to seek SNSA:</p><ul><li>In preparation for clinical trials (CT) applications to be performed in more than one MS. Where during the SNSA the involved <acronym title="National Competent Authorities" lang="">NCAs</acronym> agree that the questions raised would benefit from discussions at the Clinical Trial Coordination Group (CTCG) level, it is also possible to obtain CTCG-coordinated clinical trial expert feedback as part of the SNSA procedure.</li><li>Prior to applying for funding grants to support non-commercial clinical trials (academic researchers).</li><li>To inform the early-stage development of innovative products for which clinical trials are planned, e.g. phase I / II clinical trials, especially where there is limited existing regulatory guidance. <acronym title="European Medicines Agency" lang="">EMA</acronym> scientific advice should continue to be used for scientific advice related to the suitability of the proposed clinical development to support a centralized marketing authorisation application.</li><li>Prior to clinical trials intended to facilitate repurposing of authorised medicinal products e.g. to support new innovative therapeutic indications</li></ul><p>Phase 2 of the SNSA pilot builds on the success of the first phase of the pilot, it optimizes the procedure, while maintaining the key principles associated with SNSA. The pilot is open to applicants from different backgrounds including large pharmaceutical companies, while strongly encouraging SMEs and especially inviting academic research centres and hospitals to join. Within each SNSA procedure, each participating <acronym title="National Competent Authority" lang="">NCA</acronym> will prepare and discuss their positions on the questions raised by the applicant with a view to maximising alignment prior to a joint advice meeting with the applicant. Where divergent positions remain, these will be explained to the applicant in the joint advice meeting and subsequently be summarised in consolidated meeting minutes with a view to facilitating further consideration and appropriate follow-up upon agreement of the applicant.</p><p>The optimized pilot SNSA process will continue to complement and provide a bridge between purely national scientific advice and centralised European scientific advice procedures from <acronym title="European Medicines Agency" lang="">EMA</acronym> as well as supporting the aims of the ACT-<acronym title="European Union" lang="">EU</acronym> initiative and the CTCG.</p><p><strong>How to apply for SNSA</strong></p><p>Guidance on how to prepare and submit a formal SNSA request and relevant templates are listed below:<br> </p><ul><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-EU-IN-Guidance-for-applicants-on-Simultaneous-National-Scientific-Advice-SNSA-phase-2-pilot.pdf" target="_blank">Guidance to applicants</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2022_11_EU-IN_Guidance_for_applicants_on_Simultaneous_National_Scientific_Advice__SNSA__Briefing_book_format_and_content.pdf" target="_blank">Guidance on SNSA briefing book format and content</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-Participating-NCAs_list.pdf" target="_blank">List of participating NCAs and contact information</a> (Updated June 2024)</li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-SNSA-Procedural-Flow-chart-final.pdf">Procedural Flow chart</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-SNSA-Application-form-for-SNSA-and-pre-CTA-Advice.docx">Application form</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-SNSA-Feedback-Questionnaire-for-Applicants_.docx">Feedback Questionnaire</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-SNSA-Meeting-Minutes-Template-for-Applicants.doc">Meeting Minutes Template</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2024-06-Advice-Report-_Template-SNSA_.doc">Advice Report Template</a></li></ul><p>For any further information, please contact <a href="#" data-mailto-token="kygjrm8qlqyYdyee+ydknq,zc" data-mailto-vector="-2">snsa<span style="display:none">noSpam</span>@<span style="display:none">noSpam</span>fagg-afmps<span style="display:none">noSpam</span>.be</a>.</p><p><br><strong>Additional documents</strong><br> </p><ul><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2025_02_EU-IN_communication_on_SNSA_extension_after_pilot_phase2.pdf">Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2022_12_EU-IN_National_Scientific_Advice_Contacts.pdf">National Scientific Advice Contacts</a></li><li><a href="/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/EU-IN/2022_12_EU-IN_National_Innovation_Offices_Contacts.pdf">National Innovation Offices Contacts</a></li></ul><p><strong>Additional information</strong></p><p>Key features of the optimized SNSA procedure include:</p><ul><li>An increased number of <acronym title="National Competent Authorities" lang="">NCAs</acronym> willing to participate in SNSA procedures</li><li>A common application form, briefing book template and a single-entry point (email to <a href="#" data-mailto-token="kygjrm8qlqyYdyee+ydknq,zc" data-mailto-vector="-2">snsa<span style="display:none">noSpam</span>@<span style="display:none">noSpam</span>fagg-afmps<span style="display:none">noSpam</span>.be</a>) to reduce the administrative burden for applicants.</li><li><acronym title="Paul-Ehrlich-Institut" lang="">PEI</acronym> will liaise with the leading MS who will act as the main contact point for the applicant during the procedure.</li><li>A predictable timetable to be agreed prior to the start of each procedure</li><li>Each SNSA will involve two participating <acronym title="National Competent Authorities" lang="">NCAs</acronym> with the possibility of a third <acronym title="National Competent Authority" lang="">NCA</acronym> joining as an observer. When sufficiently justified by the applicant, participation of a CTCG representative as observer in the SNSA meeting can also be requested. In justified cases, e.g. where the request relates to a clinical trial to be performed in more than 2 MSs, the involvement of additional MSs in a single SNSA procedure will be considered subject to the agreement of the <acronym title="National Competent Authorities" lang="">NCAs</acronym>.</li></ul><p>The following principles continue to apply:</p><ul><li>All types of applicants can apply for an SNSA pilot. Pre-submission guidance can be requested via the single-entry point for academia and SMEs to assist them in preparing their scientific advice request.</li><li>Participation of an <acronym title="National Competent Authority" lang="">NCA</acronym> in any individual SNSA procedure is on a voluntary opt-in basis.</li><li>The scope of SNSA includes regulatory or scientific questions related to quality, safety and efficacy of medicinal products. Questions can relate to products under development as well as authorised products.</li><li>The advice given will be limited to the scope of the questions raised by the applicant in the briefing document.</li><li>SNSA is an opportunity for the applicants to discuss their queries with each of the <acronym title="National Competent Authorities" lang="">NCAs</acronym> involved in the procedure in a joint meeting with the possibility for the <acronym title="National Competent Authorities" lang="">NCAs</acronym> to raise questions related to clinical trials with the CTCG if considered appropriate.</li><li>The outcome of each SNSA procedure is clearly documented and reflects the position of each of the involved <acronym title="National Competent Authorities" lang="">NCAs</acronym>.</li><li>The fees for SNSA are based on the national scientific advice fees in each of the participating <acronym title="National Competent Authorities" lang="">NCAs</acronym> and should be paid directly to each participating <acronym title="National Competent Authority" lang="">NCA</acronym> in the normal manner. There is no fee relating to the involvement of an <acronym title="National Competent Authority" lang="">NCA</acronym> as an observer.</li><li>Queries related to HTA and reimbursement are currently excluded.</li></ul><p>Practical information on how to submit an SNSA request is also available on the websites of the <acronym title="National Competent Authorities" lang="">NCAs</acronym> participating in the SNSA pilots (cfr. List of participating NCA’s and contact information) and on the <a href="https://www.hma.eu/about-hma/working-groups/eu-innovation-network-eu-in.html" target="_blank">HMA </a>and <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/accelerating-clinical-trials-eu-act-eu" target="_blank" rel="noreferrer">EMA</a> websites.</p></div></div></div><div id="c7188" class="frame frame-default frame-type-text frame-layout-0"><p><strong>Borderline Classification</strong></p><p>The overall objective of this activity is to offer an informal <acronym title="European Union" lang="">EU</acronym>-wide forum for specialists with different expertise to discuss issues related to borderline products.</p><p>“Borderline classification” in the context of this <acronym title="European Union" lang="">EU</acronym>-IN sub-group is understood as referring to circumstances where a product is not clearly covered by one legal framework/regulation due to the nature of the product.</p><p>Key activities include:</p><ul><li><p>Discussing ongoing borderline cases, i.e. cases for which comments from members was requested before the scientific opinion on the product’s classification was delivered by the competent authority;</p></li><li><p>Considering the impact of new and upcoming legislations on classification of borderline products.</p></li></ul></div><div id="c6788" class="frame frame-default frame-type-text frame-layout-0"><p><strong>Horizon Scanning</strong></p><p>As part of its mandate, the <acronym title="European Union" lang="">EU</acronym> Innovation Network is conducting <strong>horizon scanning</strong> for the identification of <strong>emerging trends</strong>. This aims to identify areas where action is needed to be taken by the <a href="https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network" target="_blank" rel="noreferrer">European Medicines Regulatory Network</a> in collaboration with other stakeholders.</p></div><div id="c5499" class="frame frame-default frame-type-text frame-layout-0"><p><strong>Members and Representatives</strong></p><ul><li>The <acronym title="European Union" lang="">EU</acronym>-IN is composed of representatives of AT, BE, CZ, DE-<acronym title="Paul-Ehrlich-Institut" lang="">PEI</acronym>, DE-BfArm, DK, EE, ES, IS, FI, FR, HR, HU, IE, IT, MT, NL, NO, PL, PT, SE, SK and <acronym title="European Medicines Agency" lang="">EMA</acronym>.<br><br> New members may join.<br><br> The list of members is available <a href="https://www.ema.europa.eu/en/committees/working-parties-other-groups/eu-innovation-network-eu" target="_blank" rel="noreferrer">here</a>.</li><li><strong>Chair</strong>: Laurence O´Dwyer, HPRA, IE<br><strong>Co-chair</strong>: Falk Ehmann, <acronym title="European Medicines Agency" lang="">EMA</acronym></li><li><acronym title="European Medicines Agency" lang="">EMA</acronym> provides the secretariat for the <acronym title="European Union" lang="">EU</acronym>-IN.</li></ul></div><div id="c5497" class="frame frame-default frame-type-text frame-layout-0"><p><strong>Contact Point</strong></p><p>Secretariat<br> e-mail: <a href="#" data-mailto-token="kygjrm8CS+GLQcapcrypgyrYcky,cspmny,cs" data-mailto-vector="-2">EU-INSecretariat<span style="display:none">noSpam</span>@<span style="display:none">noSpam</span>ema.europa<span style="display:none">noSpam</span>.eu</a></p><p> </p></div></div><aside role="complementary"></aside></div><footer id="footer" role="contentinfo"><p class="footer-note">For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.</p><nav role="navigation"><ul><li><a href="/usefullinks.html">Useful Links</a></li><li><a href="/privacypolicy.html">Privacy Policy</a></li><li><a href="/credits.html">Credits & Disclaimer</a></li><li><a href="/contact.html">Contact</a></li></ul></nav><div id="printfooter" class="print-only">© Heads of Medicines Agencies - https://www.hma.eu/about-hma/working-groups/eu-innovation-network-eu-in/eu-innovation-network-eu-in.html</div></footer></div> <script src="/typo3temp/assets/compressed/merged-fd3440dd297d9f3eb56a8b686a508198.js?1728390920" type="text/javascript"></script> <script async="async" src="/_assets/2a58d7833cb34b2a67d37f5b750aa297/JavaScript/default_frontend.js?1737422418"></script>  <script type="text/javascript"> var _paq = _paq || []; _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="//www.hma.eu/statistics/"; _paq.push(['setTrackerUrl', u+'piwik.php']); _paq.push(['setSiteId', 1]); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.type='text/javascript'; g.async=true; g.defer=true; g.src=u+'piwik.js'; s.parentNode.insertBefore(g,s); })(); </script> <noscript><p><img src="//www.hma.eu/statistics/piwik.php?idsite=1" style="border:0;" alt=""></p></noscript>  </body> </html>