{"id":4238,"date":"2026-02-25T08:25:53","date_gmt":"2026-02-25T07:25:53","guid":{"rendered":"https:\/\/iph-multisite.berta-bewegt.ch\/?page_id=4238"},"modified":"2026-02-25T08:25:53","modified_gmt":"2026-02-25T07:25:53","slug":"zulassung-und-markteinfuehrung-phase-iv","status":"publish","type":"page","link":"https:\/\/interpharma.ch\/en\/themen\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/zulassung-und-markteinfuehrung-phase-iv\/","title":{"rendered":"Authorisation and product launch"},"content":{"rendered":"\n<p>Once\na medicinal product has completed all the phases and passed all the tests, the\npharmaceutical company can apply to Swissmedic for it to be authorised. When it\nsubmits the application for authorisation, the company also needs to supply\ndetailed documentation of the development process, and the efficacy, quality\nand safety of the new medicine. The company can request \u201cfast-track\u201d\nauthorisation for medicinal products intended to treat particularly serious\ndiseases or diseases for which no effective alternatives are available on the\nmarket. <\/p>\n\n\n\n<p>Authorisation\nby Swissmedic does not mean that the medicine will automatically be reimbursed\nby statutory basic health insurance. Swissmedic is responsible for assessing\nthe efficacy, safety and quality of medicines. The Federal Office of Public\nHealth (FOPH) decides whether a product must be reimbursed by the health\ninsurers, and to this end it evaluates the effectiveness, appropriateness and\ncost-effectiveness (known as the WZW criteria in the Health Insurance Act) of the\nproduct. The manufacturing company must apply to the FOPH for this assessment\nto be performed. The cost-effectiveness review, following which the definitive\nreimbursement price is determined, is based on a system of internal reference\npricing (IRP) and external reference pricing (ERP). The IRP review compares the\ncost of the new medicinal product with the cost of products that have already\nbeen authorised and lead to similar therapeutic success. The ERP review\ncompares prices in nine comparator countries (Austria, Belgium, Denmark,\nFinland, France, Germany, the Netherlands, Sweden and the United Kingdom).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Phase IV \u2013 Further studies\nand post-marketing observation<\/strong><strong><\/strong><\/h2>\n\n\n\n<p>Once\nthe medicinal product is on the market and available to patients, the\npharmaceutical company continues to study the product in a broad population in\norder to confirm the benefit-risk assessment and to identify rare side effects\nthat did not emerge during the test phases. The results of the tests that the\nmedicine has undergone are shown in the patient information leaflet in the\npack. This must be approved by the regulatory authority Swissmedic. If the\nmanufacturer learns of side effects or incidents during use of the product, it\nis required to notify Swissmedic and, if necessary, take measures to ensure\npatient safety. If major risks are identified, the pharmaceutical companies\ninform doctors and pharmacists via a rapid alert system in consultation with\nthe authorities.<\/p>\n\n\n\n<p>The\nsuccess rate for new medicines in obtaining authorisation is very low. Just one\nproduct out of 10,000 candidates ultimately comes onto the market. Two of the\nreasons why the development of a new medicine may be halted are insufficient\nefficacy and serious side effects. Competition between manufacturers can also\nlead to research being stopped if, for example, a different supplier brings a\nsimilar medicinal product onto the market sooner.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Once a medicinal product has completed all the phases and passed all the tests, the pharmaceutical company can apply to Swissmedic for it to be authorised. When it submits the application for authorisation, the company also needs to supply detailed documentation of the development process, and the efficacy, quality and safety of the new medicine. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4288,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4238","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Authorisation and product launch - Interpharma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/interpharma.ch\/en\/themen\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/zulassung-und-markteinfuehrung-phase-iv\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Authorisation and product launch\" \/>\n<meta property=\"og:description\" content=\"Once a medicinal product has completed all the phases and passed all the tests, the pharmaceutical company can apply to Swissmedic for it to be authorised. 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