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In 2025, the overall timeline for approval of new clinical trials ranged from 39 to 136 calendar days (average \u2013 76 days, median \u2013 71 days). In most cases, the actual duration of the procedure exceeded the minimum timelines defined by the current regulatory framework, indicating potential for further process improvement and alignment with the minimum feasible regulatory timeframes. These are the findings of a survey conducted among member companies of the Clinical Trials Subcommittee of the European Business Association.<\/p>\n
Even excluding the time required for applicants to prepare responses to queries (Form 16), the timelines remained significant (average \u2013 65 days, median \u2013 64 days), indicating accumulated delays at certain stages of the review and administrative process.<\/p>\n
Financial and operational procedures and dossier submission stage<\/strong><\/p>\n A significant impact on the extension of the overall timeline is the dossier submission stage after the application is filed, with an average duration of 16 calendar days, often exceeding two weeks. This stage includes receiving the invoice and paying the State Expert Centre (SEC) review fee, without which the expert evaluation cannot commence.<\/p>\n In particular, the time required to receive the invoice ranged on average from 3 to 10 calendar days (minimum \u2013 1 day, maximum \u2013 13 days). After that, it took an additional 3\u20137 days for the invoice to appear in the applicant\u2019s account. Payment processing, depending on companies\u2019 internal financial procedures, took from 2 working days up to 2 weeks. Combined, these factors can significantly delay both dossier submission and the start of the review, even when materials are fully prepared.<\/p>\n Review process, NEC meetings, and MoH decision-making<\/strong><\/p>\n The duration of the clinical trial dossier review (excluding Form 16 response time) ranged from 15 to 69 calendar days, with an average of 40 days. In 75% of cases, this exceeded the 30 calendar days stipulated by Ministry of Health Order No. 690.<\/p>\n An additional factor contributing to delays was the time gap between the completion of the review and the meetings of the Scientific and Expert Council (SEC\/NEC): in more than half of the cases, the waiting time exceeded 4 days and occasionally reached up to 20 calendar days.<\/p>\n Following the NEC meeting date, the average time for issuance of the Ministry of Health order approving the clinical trial was 9 calendar days, with 90% of cases exceeding the 5-day period defined by Order No. 690.<\/p>\n Substantial amendments<\/strong><\/p>\n The review of substantial amendments in 2025 also showed significant variability, ranging from 20 to 126 calendar days. Assessments of changes compared to previous years vary: more than one-third of respondents reported no change, almost one-third noted some reduction, while others reported longer timelines or difficulty in predicting duration. This indicates process inconsistency and limited predictability.<\/p>\n Responsibility areas and optimisation potential<\/strong><\/p>\n Survey results show that a significant portion of the overall timeline is formed at the initial stages and depends on applicants\u2019 actions.<\/p>\n Key factors that can meaningfully affect process speed include:<\/p>\n An important area is the development of digital tools, including active company participation in testing and practical use of such systems. This includes, in particular, submission of documents via the MoH Single Window through the applicant\u2019s portal.<\/p>\n At the same time, survey results indicate additional potential for timeline reduction and process optimisation on the side of regulatory authorities. In particular:<\/p>\n An additional lever is more flexible and predictable scheduling of NEC\/NERC meetings, which would reduce non-productive gaps between stages.<\/p>\n Special attention should be paid to compliance with timelines established under Ministry of Health Order No. 690, particularly regarding issuance of orders approving clinical trials and substantial amendments.<\/p>\n The introduction of systematic monitoring and KPIs could improve process predictability and increase trust from international sponsors.<\/p>\n Reducing the overall timelines for approval and initiation of clinical trials<\/strong> is of strategic importance for Ukraine, particularly in the context of full-scale war. It is one of the key factors enhancing the country\u2019s attractiveness for clinical research.<\/p>\n The EBA Clinical Trials Subcommittee considers the results of this survey a basis for further constructive dialogue with the Ministry of Health and the State Expert Centre, as well as for joint efforts to optimise regulatory procedures and create conditions for the sustainable development of clinical research in Ukraine.<\/p>\n For reference:<\/em><\/strong><\/p>\n The survey was conducted by the European Business Association Clinical Trials Subcommittee among member companies to analyse actual timelines for approval of new clinical trials and substantial amendments in 2025. Seventeen companies participated (8 contract research organisations and 9 sponsors), providing data on 73 new clinical trials submitted between 1 January and 31 December 2025.<\/em><\/p>\n The purpose of the survey was to compare actual regulatory review timelines with the requirements of Ministry of Health Order No. 690 and identify stages of the process with the greatest potential for reduction through operational improvements by both regulatory authorities and applicants.<\/em><\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" In 2025, the overall timeline for approval of new clinical trials ranged from 39 to 136 calendar days (average \u2013 76 days, median \u2013 71 days). In most cases, the actual duration of the procedure exceeded the minimum timelines defined by the current regulatory framework, indicating potential for further process improvement and alignment with the […]<\/p>\n","protected":false},"author":33544,"featured_media":747830,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n\n
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