Ukraine Needs to Improve the Legislation on Clinical Trials

Amidst the pandemic, pharmaceutical companies encountered new challenges in the conduct of clinical trials of bioequivalence of medicinal products. Their effective solving and ensuring the continuity of the clinical trial process and launching new medicines to the market require wide implementation of digital technologies, improvement of the system of electronic document flow at the national level and improvement of the legislative and regulatory framework for clinical trials. This was stated by Oleksandr Torhun, Director for Regulatory Affairs of “Darnitsa” Pharmaceutical Company, during the research-to-practice conference “Clinical Trials of Medicinal Products in Ukraine: New Challenges and Answers to Them”.

He emphasized that the digitalization of the clinical study process is a part of the strategy of Darnitsa’s transformation into a fully digital company. Torhun reminded that the pharmaceutical company had already transferred the drug life cycle into digital form. Together with the introduction of remote monitoring of patients and the decentralization of clinical trials, this has made it possible to compensate for time losses at various stages of research and development and to ensure the necessary speed of release of new drugs despite the limitations caused by the quarantine.

“Darnitsa already uses certain electronic forms, such as (eCRF and eTMF). Together with the changes to the legal and regulatory framework and introduction of other digital forms (electronic signature, electronic informed consent, electronic application submission form etc.) this will make it possible to create a system of electronic document flow in Ukraine and to digitalize the area of public health,” Torhun noted.

Darnitsa’s Director for Regulatory Affairs also added that the key requirement to clinical trials during the COVID-19 pandemic is the maintenance of a balance between the integrity of the trial data and safety, welfare and observance of rights of its subjects.

“We welcome the readiness of the Ministry of Health of Ukraine and the State Expert Center of the Ministry of Health of Ukraine to conduct a dialogue. Strengthening of efforts of manufacturers and government agencies will accelerate the introduction of legislative changes governing the conduct of clinical trials, and will bring the Ukrainian practice as close as possible to the global one,” Oleksandr Torhun noted.

As previously reported, Darnitsa has completed 8 bioequivalence studies of medicines for treatment of cardiac and central nervous system diseases which were conducted in 2018-2020 in European laboratories.