<\/p>\n
The Clinical Trials Subcommittee of the European Business Association held an online meeting dedicated to the practical aspects of the new Procedure for the Conduct of Clinical Trials of Medicinal Products, approved by Order of the Ministry of Health of Ukraine No. 184.<\/p>\n
The new procedure has been developed as part of the implementation of Ukraine\u2019s new Law \u201cOn Medicinal Products\u201d and the transition to a new regulatory model in the field of medicinal product circulation. In line with the legislation, the launch of the single regulatory authority \u2014 the Ukrainian Pharmaceutical Agency \u2014 is scheduled for 1 January 2027.<\/p>\n
The Association has been actively involved in shaping this document and has consistently worked to improve it and align it with European regulatory approaches. In particular, the Clinical Trials Subcommittee contributed to its refinement both during the preparatory stage within a working group involving the Ministry of Health and the State Expert Centre, and throughout three rounds of public consultation, providing comments and proposals, a significant number of which were taken into account.<\/p>\n
During the meeting, participants discussed the key innovations of the new procedure, potential challenges for applicants\/sponsors and the research community, as well as the practical application of certain provisions. Special attention was paid to provisions that may require further clarification. The speakers \u2014 representatives of Arzinger, the Subcommittee\u2019s legal partner, Lana Sinichkina, Partner and Head of Healthcare and Pharmaceuticals Practice, and Kateryna Oliinyk, Partner of Intellectual Property and TMT Practice \u2014 provided expert explanations on the regulatory aspects of implementing the new requirements and shared their views on the future application of the relevant provisions.<\/p>\n
The European Business Association extends its gratitude to the experts from its legal partner Arzinger for their insightful presentations and practical clarifications, as well as to all participants for their active engagement and constructive discussion.<\/p>\n
The Clinical Trials Subcommittee of the Association will continue working on the issues discussed, including ongoing dialogue with regulatory authorities, to ensure the successful implementation of the new approaches in the field of clinical trials. We are convinced that open dialogue between the government and business is a key prerequisite for the effective implementation of new regulatory requirements and the further development of the clinical research sector in Ukraine.<\/p>\n
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The Clinical Trials Subcommittee of the European Business Association held an online meeting dedicated to the practical aspects of the new Procedure for the Conduct of Clinical Trials of Medicinal Products, approved by Order of the Ministry of Health of Ukraine No. 184. The new procedure has been developed as part of the implementation of […]<\/p>\n","protected":false},"author":33544,"featured_media":751139,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n