{"id":655190,"date":"2025-07-01T18:13:00","date_gmt":"2025-07-01T15:13:00","guid":{"rendered":"https:\/\/eba.com.ua\/?p=655190"},"modified":"2025-07-02T11:01:58","modified_gmt":"2025-07-02T08:01:58","slug":"ectd-vazhlyvyj-krok-na-shlyahu-tsyfrovizatsiyi-regulyatornyh-protsesiv-u-sferi-ohorony-zdorov-ya","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/ectd-vazhlyvyj-krok-na-shlyahu-tsyfrovizatsiyi-regulyatornyh-protsesiv-u-sferi-ohorony-zdorov-ya\/","title":{"rendered":"[:ua]eCTD &#8211; \u0432\u0430\u0436\u043b\u0438\u0432\u0438\u0439 \u043a\u0440\u043e\u043a \u043d\u0430 \u0448\u043b\u044f\u0445\u0443 \u0446\u0438\u0444\u0440\u043e\u0432\u0456\u0437\u0430\u0446\u0456\u0457 \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u043d\u0438\u0445 \u043f\u0440\u043e\u0446\u0435\u0441\u0456\u0432 \u0443 \u0441\u0444\u0435\u0440\u0456 \u043e\u0445\u043e\u0440\u043e\u043d\u0438 \u0437\u0434\u043e\u0440\u043e\u0432\u2019\u044f[:en]eCTD \u2013 A key step towards the digitalisation of regulatory processes in healthcare[:]"},"content":{"rendered":"<p><\/p>\n<div class=\"slider__outer-container\">\n\t<div class=\"slider\">\n\n\t\t<div class=\"slider__container\">\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_181-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_181-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_181-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_158-scaled.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_158-scaled.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/Photo_158-scaled.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div data-caption=\"\" data-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/5413421224656238206.jpg\" data-full-src=\"https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/5413421224656238206.jpg\">\n\t\t\t\t\t<div class=\"slide-inner\" style=\"background-image: url(https:\/\/eba.com.ua\/wp-content\/uploads\/2025\/07\/5413421224656238206.jpg)\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t<div class=\"slider__panel\">\n\n\t\t\t<div class=\"slider__info-container\">\n\n\t\t\t\t<div class=\"slider__counters\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__counter slider__counter--current\">01<\/span>\/<span class=\"slider__counter slider__counter--total\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t\t<div class=\"slider__title\">\n\t\t\t\t\t<div class=\"container\">\n\t\t\t\t\t\t<span class=\"slider__title__text\" style=\"display:none\">Photo: <\/span>\n\t\t\t\t\t\t<span class=\"slider__title__description\"><\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__nav slider__nav--prev icon icon-long-arrow\">\n\t\t\t\t<span class=\"icon icon-arrow-l-thin\"><\/span>\n\t\t\t<\/div>\n\t\t\t<div class=\"slider__nav slider__nav--next icon icon-long-arrow arrow-right\">\n\t\t\t<\/div>\n\n\t\t\t<div class=\"slider__fullscreen icon icon-full-size js_slick-fullscreen\"><\/div>\n\n\t\t<\/div>\n\n\t\t<span class=\"close-full-size\"><\/span>\n\n\t<\/div>\n<\/div>\n<p data-start=\"148\" data-end=\"644\">On 17 June 2025, the forum \u201cPHARMEXPERT 2025. eCTD and Pricing in Ukraine \u2013 a Strategic Path to Integration into the International Regulatory Framework\u201d took place, bringing together over 300 participants from Ukraine and across Europe. Attendees included leading industry experts, representatives of international institutions, national regulators from Croatia, Poland, Denmark, Moldova, and Portugal, as well as public authorities, patient organisations, academia, and the business community.<\/p>\n<p data-start=\"646\" data-end=\"844\">Anna Bezruk, Manager of the Health Care Committee at the European Business Association, spoke at one of the panel discussions dedicated to the implementation of the electronic eCTD format in Ukraine.<\/p>\n<p data-start=\"846\" data-end=\"1291\">In her speech, Anna highlighted that pharmaceutical companies which are members of the EBA support the introduction of eCTD. It is a crucial step towards the digitalisation of regulatory processes in healthcare. This initiative not only aligns with global trends but also contributes to simplifying the preparation and updating of registration dossiers, enhancing transparency, and improving the quality of engagement with the regulator.<\/p>\n<p data-start=\"1293\" data-end=\"1788\">Moreover, a significant outcome of the dialogue between the business sector and the state has been the adoption of a European approach to the Baseline submission \u2013 specifically, recognising its voluntary nature and providing guidance on when it is feasible. This approach is especially relevant in the context of the capacities and resources of domestic manufacturers, as well as for medicinal products that were developed and registered long before the shift to the electronic dossier standard.<\/p>\n<p data-start=\"1790\" data-end=\"2134\">Also important for the pharmaceutical sector are the preliminary clarifications from the Ministry of Health of Ukraine. These outline the stages of transition to the mandatory eCTD format for the registration of new medicinal products, as well as setting out the conditions of a &#8220;transitional period&#8221; for other types of registration procedures.<\/p>\n<p data-start=\"2136\" data-end=\"2528\">At the same time, it was emphasised that full digitalisation of the process has not yet been completed. In particular, the three-stage procedure for dossier submission remains in force. One of the stages \u2013 the submission of the registration form \u2013 still requires paper-based documentation. The Health Care Committee of the EBA hopes that this issue will be resolved in the near future.<\/p>\n<p data-start=\"2530\" data-end=\"2781\">Business representatives also look forward to the introduction of PSUR (Periodic Safety Update Report) submissions in eCTD format, which would allow the pharmacovigilance area to be fully integrated into the overall registration and monitoring system.<\/p>\n<p data-start=\"2783\" data-end=\"3422\">Anna Bezruk stressed that the implementation of eCTD opens up new opportunities for building a modern, efficient, and transparent regulatory system in Ukraine. She also noted the need for the full digitalisation of the future state control body, the creation of which is envisaged by the new Law of Ukraine \u201cOn Medicinal Products\u201d. The EBA expresses its gratitude to the Ministry of Health of Ukraine and the State Expert Centre of the Ministry of Health for their efforts to harmonise these standards with European requirements. This is of strategic importance for further aligning Ukraine\u2019s regulatory system with EU legislation.<\/p>\n<p data-start=\"3424\" data-end=\"3724\">The European Business Association thanks the forum organisers for addressing these pressing issues. We hope that the implementation of the eCTD format in Ukraine will be successful and will serve as a foundation for further effective reform of the regulatory environment in the pharmaceutical sector.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>On 17 June 2025, the forum \u201cPHARMEXPERT 2025. eCTD and Pricing in Ukraine \u2013 a Strategic Path to Integration into the International Regulatory Framework\u201d took place, bringing together over 300 participants from Ukraine and across Europe. Attendees included leading industry experts, representatives of international institutions, national regulators from Croatia, Poland, Denmark, Moldova, and Portugal, as [&hellip;]<\/p>\n","protected":false},"author":33544,"featured_media":655192,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>eCTD \u2013 A key step towards the digitalisation of regulatory processes in healthcare - European Business Association<\/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:\/\/eba.com.ua\/ectd-vazhlyvyj-krok-na-shlyahu-tsyfrovizatsiyi-regulyatornyh-protsesiv-u-sferi-ohorony-zdorov-ya\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"eCTD \u2013 A key step towards the digitalisation of regulatory processes in healthcare - European Business Association\" \/>\n<meta property=\"og:description\" content=\"On 17 June 2025, the forum \u201cPHARMEXPERT 2025. eCTD and Pricing in Ukraine \u2013 a Strategic Path to Integration into the International Regulatory Framework\u201d took place, bringing together over 300 participants from Ukraine and across Europe. 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