{"id":450,"date":"2025-02-02T19:34:54","date_gmt":"2025-02-02T18:34:54","guid":{"rendered":"https:\/\/clinicaltrials4u.pl\/?p=450"},"modified":"2025-02-02T19:34:54","modified_gmt":"2025-02-02T18:34:54","slug":"31-stycznia-2025-ostateczny-termin-dostosowania-badan-klinicznych-do-nowych-przepisow","status":"publish","type":"post","link":"https:\/\/clinicaltrials4u.pl\/en\/2025\/02\/02\/31-stycznia-2025-ostateczny-termin-dostosowania-badan-klinicznych-do-nowych-przepisow\/","title":{"rendered":"31 January 2025 \u2013 Final Deadline for Adapting Clinical Trials to the New Regulations"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"450\" class=\"elementor elementor-450\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6b30fec8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6b30fec8\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-52d75e01\" data-id=\"52d75e01\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1196d472 elementor-widget elementor-widget-text-editor\" data-id=\"1196d472\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>As of\u00a0<strong>31 January 2025,<\/strong>\u00a0the transitional period for applying previous national clinical trial regulations under the Pharmaceutical Law Act will end.\nFrom that date onwards, new rules introduced under the Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use will apply.<\/p><p>\u00a0<\/p><p><strong>Key changes include:<\/strong><\/p><ol><li><strong>Alignment with EU Regulation No. 536\/2014:<\/strong>The new Act implements the provisions of Regulation (EU) No. 536\/2014 of the European Parliament and of the Council, harmonizing procedures related to the conduct of clinical trials within the European Union.<div>Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use \u2013\u00a0<a href=\"https:\/\/dziennikustaw.gov.pl\/DU\/2023\/605?\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/dziennikustaw.gov.pl\/DU\/2023\/605?&amp;source=gmail&amp;ust=1738606760479000&amp;usg=AOvVaw1nT-kr6kanUdYUJv7IYNgW\">Journal of Laws 2023, item 605<\/a><\/div><p>\u00a0<\/p><\/li><li><strong>Mandatory Registration in CTIS:<\/strong>Starting from 31 January 2025, all clinical trials conducted in Poland must be registered in the Clinical Trials Information System (CTIS).\nTrials previously approved under Directive 2001\/20\/EC, which are still ongoing, must be transitioned and registered in CTIS in compliance with the Regulation.\nFailure to comply with this obligation may result in such trials being considered non-compliant with the law.<div><a href=\"https:\/\/www.gov.pl\/web\/urpl\/informacja-prezesa-urzedu-z-dnia-28-pazdziernika-2024-r-w-sprawie-stosowania-przepisow-rozporzadzenia-parlamentu-europejskiego-i-rady-ue-nr-5362014-i-systemu-informacji-o-badaniach-klinicznych-ctis\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/www.gov.pl\/web\/urpl\/informacja-prezesa-urzedu-z-dnia-28-pazdziernika-2024-r-w-sprawie-stosowania-przepisow-rozporzadzenia-parlamentu-europejskiego-i-rady-ue-nr-5362014-i-systemu-informacji-o-badaniach-klinicznych-ctis&amp;source=gmail&amp;ust=1738606760479000&amp;usg=AOvVaw3iRgYkGAu7vmoFeAL3r96x\">Notice of the President of the Office (dated 28 October 2024) on the application of Regulation (EU) No. 536\/2014 and information on CTIS \u2013 Office for Registration of Medicinal Products, Medical Devices and Biocidal Products \u2013 gov.pl<\/a><\/div><\/li><\/ol><div><p>Detailed guidance on the transfer process for trials approved under Directive 2001\/20\/EC to CTIS is available on the EMA website:\u00a0<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-12\/transition_ct_dir-reg_guidance_en.pdf\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/health.ec.europa.eu\/system\/files\/2023-12\/transition_ct_dir-reg_guidance_en.pdf&amp;source=gmail&amp;ust=1738606760479000&amp;usg=AOvVaw38Bk4t7Fe4PBn9iUeczYtO\">https:\/\/health.<wbr \/>ec.europa.eu\/system\/files\/<wbr \/>2023-12\/transition_ct_dirreg_ guidance_en.pdf<\/a><\/p><p><span style=\"color: #1b1b1b; font-family: Open Sans, sans-serif;\">3.\u00a0<\/span><strong>Update of Documentation Related to Personal Data Processing<\/strong>In accordance with Article 90(1) and (2) of the Act of 9 March 2023, by 31 January 2025 it is required to update all documentation related to the processing of personal data, including data concerning clinical trial participants.\nThis update aims to ensure compliance with the new legal requirements regarding data protection.<\/p><p>The implementation of these changes is intended to enhance the safety of clinical trial participants and to harmonize research processes across the European Union.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Z dniem\u00a031 stycznia 2025 roku\u00a0up\u0142ywa termin stosowania dotychczasowych przepis\u00f3w dotycz\u0105cych bada\u0144 klinicznych okre\u015blonych w Ustawie Prawo farmaceutyczne. Od tego momentu obowi\u0105zywa\u0107 b\u0119d\u0105 nowe regulacje wprowadzone Ustaw\u0105 z dnia 9 marca 2023 roku o badaniach klinicznych produkt\u00f3w leczniczych stosowanych u ludzi. Kluczowe zmiany obejmuj\u0105: Dostosowanie do Rozporz\u0105dzenia UE 536\/2014: Nowa ustawa implementuje przepisy Rozporz\u0105dzenia Parlamentu Europejskiego [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-450","post","type-post","status-publish","format-standard","hentry","category-aktualnosci"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>31 stycznia 2025 \u2013 Ostateczny termin dostosowania bada\u0144 klinicznych do nowych przepis\u00f3w - Clinicaltrials4u<\/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:\/\/clinicaltrials4u.pl\/en\/2025\/02\/02\/31-stycznia-2025-ostateczny-termin-dostosowania-badan-klinicznych-do-nowych-przepisow\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"31 stycznia 2025 \u2013 Ostateczny termin dostosowania bada\u0144 klinicznych do nowych przepis\u00f3w - Clinicaltrials4u\" \/>\n<meta property=\"og:description\" content=\"Z dniem\u00a031 stycznia 2025 roku\u00a0up\u0142ywa termin stosowania dotychczasowych przepis\u00f3w dotycz\u0105cych bada\u0144 klinicznych okre\u015blonych w Ustawie Prawo farmaceutyczne. 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