<\/p>\n
The European Business Association positively assesses the decision of the Ministry of Health of Ukraine to withdraw the draft amendments to Order No. 690, which proposed limiting participation in clinical trials exclusively to university clinics and clinical bases. This decision is an important step toward preserving the sustainable development of the sector, ensuring equal opportunities for healthcare institutions of various ownership types, and further harmonizing the Ukrainian regulatory environment with European Union requirements.<\/p>\n
The issue of whether the proposed amendments aligned with European practices and the potential risks they posed for attracting investment into the sector was a key focus of discussion during the meeting of the EBA Clinical Trials Subcommittee Board with the Minister of Health, Viktor Liashko, on 5 February, as well as during the dialogue on February 10 with the newly appointed Director of the State Expert Center of the Ministry of Health, Edem Adamanov. Throughout these discussions and in public communications, the EBA consistently emphasized the inadmissibility of such restrictions and their potential negative impact on the conduct of clinical trials and on Ukraine\u2019s attractiveness for international sponsors of clinical trials.<\/p>\n
The proposed amendments would have effectively introduced an administrative narrowing of the list of healthcare institutions eligible to serve as clinical trial sites, based on their formal status or subordination rather than their actual ability to comply with Good Clinical Practice (GCP) requirements. Such an approach is inconsistent with the logic of ICH GCP (E6 R2\/R3) and EU Regulation No. 536\/2014,\u00a0 according to which the capacity of a trial site is determined by functional criteria: a quality system, adequate infrastructure, personnel qualifications, inspection history, and practical experience in conducting clinical trials<\/p>\n
The EBA expresses its appreciation to the Ministry of Health of Ukraine and the State Expert Center for their openness to professional dialogue, constructive approach, and willingness to consider the well\u2011grounded position of the business community and expert stakeholders. This decision taken reaffirms the state\u2019s commitment to the principles of transparency, equal access, and compliance with international standards in the field of clinical trials of medicinal products.<\/p>\n
The discussion around the draft amendments to Order No. 690 also demonstrated a high level of consolidation within the clinical trials sector. Professional associations representing the interests of investigators, healthcare institutions of various ownership types, service providers, and expert communities acted in a coordinated manner, forming a well\u2011substantiated position in support of maintaining an open and competitive clinical trials system in Ukraine.<\/p>\n
The EBA Clinical Trials Subcommittee, representing the interests of international and local sponsors, contract research organizations, logistics operators, and other companies involved in conducting clinical trials, has made significant efforts to convey to the Ministry of Health, the State Expert Center, and other discussion participants the international requirements, GCP principles, global approaches to the organization of clinical trials, and the critical importance of adhering to them in Ukraine.<\/p>\n
The EBA\u2019s position was developed through close cooperation with a wide range of stakeholders, including patient organizations, Members of the Parliament of Ukraine, the Business Ombudsman Council, partner associations, and expert communities. The Association sincerely thanks all partners for their coordination, professionalism, and support, which were instrumental in achieving the shared result.<\/p>\n
The European Business Association will continue to advocate for the interests of the sector, promote the harmonization of the regulatory environment with European approaches, and work to maintain and strengthen Ukraine\u2019s position as a reliable, predictable, and responsible partner in the field of clinical trials. We will continue to support transparent and regular dialogue with government authorities, enhance expert cooperation, and contribute to the development of sustainable partnerships between business, the state, and the professional community.<\/p>\n
Just as the sector united to address the issue of Order No. 690, it is essential to continue working collectively now to ensure the systemic development of clinical trials in Ukraine. Only through joint efforts of the state and the professional community can sustained positive progress be achieved, the country\u2019s investment attractiveness improved and patient access to innovative treatment options expanded.<\/p>\n
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The European Business Association positively assesses the decision of the Ministry of Health of Ukraine to withdraw the draft amendments to Order No. 690, which proposed limiting participation in clinical trials exclusively to university clinics and clinical bases. This decision is an important step toward preserving the sustainable development of the sector, ensuring equal opportunities […]<\/p>\n","protected":false},"author":33544,"featured_media":717976,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n