<\/p>\n
On 9 April, the Clinical Trials Subcommittee of the European Business Association held its regular quarterly meeting, during which it presented to the community the results of its activities for Q1 2026, as well as the development of the clinical trials sector in Ukraine.<\/p>\n
Among the main topics discussed were the establishment of a new State Control Authority, cooperation with public authorities, and the Subcommittee\u2019s current and priority initiatives in clinical trials.<\/p>\n
The meeting began with an overview of clinical trials approvals for the first quarter of 2026. A substantial increase was observed compared to the same periods during previous years of\u00a0 the full-scale invasion: the number of approved new clinical trials increased by 2.7\u20134 times, while the number of approved clinical trial sites increased by 2.9\u20136.5 times.<\/p>\n
Particular attention was given to the process of establishing the State Control Authority, tentatively named the Ukrainian Pharmaceutical Agency. Active work is currently underway to launch the new regulatory body in parallel with the entry into force of the new Law of Ukraine \u201cOn Medicinal Products\u201d on 1 January 2027. The Clinical Trials Subcommittee has provided input on key draft regulatory acts related to clinical trials, including the draft Procedure for Conducting Clinical Trials, requirements for clinical trial sites, the model regulation for ethics committees (which have already undergone three stages of public consultation), licensing conditions, and provisions on the establishment of the Ukrainian Pharmaceutical Agency, among others. The Subcommittee continues to actively contribute to the development of the regulatory framework in order to create a favourable environment for sector growth and Ukraine\u2019s European integration.<\/p>\n
Throughout Q1, the Subcommittee also actively engaged with public authorities, including the Ministry of Health, the State Expert Centre, the State Service on Medicines and Drugs Control, and the Verkhovna Rada of Ukraine. A series of meetings were held during which the consolidated position of the business community was presented, in particular regarding secondary legislation under the new Law of Ukraine \u201cOn Medicinal Products\u201d in relation to clinical trials.<\/p>\n
Participants also highlighted the results of work on the Ministry of Health\u2019s initiative to amend the procedure for conducting clinical trials, which proposed limiting their conduct exclusively to university hospitals and clinical bases. The withdrawal of the draft order was the result of coordinated efforts by the EBA Clinical Trials Subcommittee and its Board, as well as active engagement with the Ministry of Health, the State Expert Centre, and the professional community.<\/p>\n
We thank the member companies of the Clinical Trials Subcommittee for their coordinated, active, and effective work.<\/p>\n
<\/p>","protected":false},"excerpt":{"rendered":"
On 9 April, the Clinical Trials Subcommittee of the European Business Association held its regular quarterly meeting, during which it presented to the community the results of its activities for Q1 2026, as well as the development of the clinical trials sector in Ukraine. Among the main topics discussed were the establishment of a new […]<\/p>\n","protected":false},"author":33544,"featured_media":734210,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n