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The report emphasizes strengthened surveillance and pharmacovigilance, including safety updates for healthcare professionals, market monitoring, vigilance and independent monitoring for devices, and measures against illegal products. It also documents governance, risk management and compliance, strategic objectives, and financial statements with balance sheet and income statement notes.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/annual-report-2025-foreword/565781/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/annual-report-2025-foreword/565781.png","ImageObject",442,249,{"name":88,"@type":89},"acoobca","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-21","2026-10-13",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What turning point does Swissmedic describe for 2025?","Question",{"text":108,"@type":109},"Swissmedic states that 2025 is a turning point due to leadership personnel changes, deterioration of the financial situation, and digital transformation requiring radical adjustments.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How did Swissmedic perform against regulatory deadlines in 2025?",{"text":113,"@type":109},"The report highlights strong performance and reliable fulfilment of its legal mandate, evidenced by high adherence to regulatory deadlines and confirmation by external evaluations of authorisation times.",{"name":115,"@type":106,"acceptedAnswer":116},"What governance changes are mentioned for leadership and the Agency Council?",{"text":117,"@type":109},"The report describes an operational management transition with Philippe Girard taking over from October and notes plans for new composition from 2026, including appointments of new members and a new Vice Chair.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},565781,1792066265,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":79,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":141},3985747870733,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","ANNUAL REPORT 2025  \nMission  \nOur competence – for therapeutic products you can trust.  \nContents 3  \nCONTENTS  \n6 Foreword  \n6 Together through a year of radical change  \n8 Swissmedic at a glance  \n8 Core tasks of Swissmedic  \n9 Our stakeholders  \n10 People, culture and values  \n11 External experts  \n12 Organisational chart  \n13 Strategy and sustainability  \n13 Strategic objectives 2023–2026  \n14 Sustainable development  \n16 Stepping up surveillance of therapeutic product safety: Focus on collaboration  \n17 Governance  \n17 Corporate Governance  \n17 Organisation  \n18 Agency Council  \n20 Management Board  \n21 Risk management and compliance  \n22 Medicinal Products – Standards product group  \n22 Legal Framework product  \n22 Technical Standards product  \n24 Medicinal Products – Information product group  \n24 Informing the General Public product  \n24 Informing the Therapeutic Products Sector product  \n27 Medicinal Products – Market Access product group  \n27 Authorisation product  \n27 Overview  \n28 First authorisations  \n30 Authorisation procedures  \n31 Human medicinal products  \n33 Special human medicinal product and transplant product categories  \n34 Complementary and herbal medicines  \n35 Veterinary medicinal products  \n36 Appeals procedure  \n37 Medicinal products: facts and figures  \n38 Licensing product  \n38 Overview  \n39 Establishment licences  \n39 Licences under Article 4 NarcA  \n39 Licences for clinical trials  \n40 Import licences for vaccines and blood products  \n40 Certificates for medicinal products and ATMPs  \n41 Batch assessment and plasma pool tests  \n4 Contents  \n42 Laboratory analyses and test method development  \n42 Inspections  \n45 Other monitoring activities  \n45 Appeals procedure  \n46 Establishment licences in facts and figures  \n47 Medicinal Products – Market Surveillance product group  \n47 Overview  \n48 Vigilance product  \n48 Human medicinal products vigilance  \n49 Signals and safety reports  \n50 Introduction of Safety Update – Updates to Information for healthcare professionals  \n50 Introduction of mandatory identification of safety-relevant information  \n50 Vigilance for veterinary medicinal products  \n51 Market monitoring of medicinal products product  \n51 Quality defects and batch recalls  \n52 Out-of-stock products  \n52 Control of advertising  \n53 Measures against illegal medicinal products  \n54 Appeals procedure  \n55 Medicinal Products – Penal Law product group  \n55 Penal Law product  \n58 Medical Devices – Standards product group  \n58 Legal Framework product  \n58 Technical Standards product  \n59 Medical Devices – Information product group  \n59 Informing the General Public product  \n59 Informing the Therapeutic Products Sector product  \n61 Medical Devices – Market Access product group  \n61 Licensing product  \n61 Placing on the market  \n61 Clinical trials  \n62 Export certificates  \n62 swissdamed – medical device database  \n63 Medical devices: facts and figures  \n64 Medical Devices – Market Surveillance product group  \n64 Vigilance product  \n64 Materiovigilance  \n65 Market Monitoring product  \n65 Independent monitoring  \n65 Market monitoring procedures  \n66 Notified bodies and inspections  \n66 Hospital inspections  \n66 Appeals procedure  \n67 Medical Devices – Penal Law product group  \n67 Penal Law product  \nContents 5  \n68 Balance sheet  \n69 Income statement  \n70 Statement of comprehensive income  \n70 Cash flow statement  \n71 Statement of changes in equity  \n72 Annex  \n72 Operating activities  \n72 Summary of the main accounting principles  \n77 Risk assessment and risk management  \n78 Valuation uncertainties  \n78 Notes on the balance sheet  \n78 1 Cash and cash equivalents  \n78 2 Receivables from sales and services  \n79 3 Financial assets  \n80 4 Fixed assets  \n81 5 Real estate  \n82 6 Intangible assets  \n83 7 Right of use  \n84 8 Other commitments  \n84 9 Deferred income  \n84 10 Other current provisions  \n85 11 Pension provision  \n90 Notes on the income statement  \n90 12 Procedural fees and income pursuant to Art","cbCaifnhniOxOpZo","https://ap.wps.com/l/cbCaifnhniOxOpZo","pdf",10162818,98,"English","# Foreword\n## Together through a year of radical change\n## Changes to management and governance\n## Worsening financial situation","[{\"question\":\"What turning point does Swissmedic describe for 2025?\",\"answer\":\"Swissmedic states that 2025 is a turning point due to leadership personnel changes, deterioration of the financial situation, and digital transformation requiring radical adjustments.\"},{\"question\":\"How did Swissmedic perform against regulatory deadlines in 2025?\",\"answer\":\"The report highlights strong performance and reliable fulfilment of its legal mandate, evidenced by high adherence to regulatory deadlines and confirmation by external evaluations of authorisation times.\"},{\"question\":\"What governance changes are mentioned for leadership and the Agency Council?\",\"answer\":\"The report describes an operational management transition with Philippe Girard taking over from October and notes plans for new composition from 2026, including appointments of new members and a new Vice Chair.\"}]","ANNUAL REPORT 2025 - Foreword | PDF",1791857998,34]