Ukraine sets the course on the digitalization of clinical trials
On January 13, the Ministry of Health of Ukraine unveiled for public discussion a draft order on amendments to the Procedure for conducting clinical trials of drugs and examination of clinical trial materials.
It should be noted that the proposal of the European Business Association was taken into account – the introduction of digitalization in the approval and conduct of clinical trials in Ukraine (submission/storage of documents in electronic form, electronic form of primary documents, and electronic informed consent, etc).
Digitalization is an important step forward for the field of clinical trials in Ukraine, especially given the launch of the new Regulation (EU) 536/2014, which facilitates and accelerates the conduct of clinical trials in the EU and the EEA.
After such major changes in European legislation, all our efforts should be aimed at simplifying the regulatory field – to speed up all approvals and start clinical trials while maintaining the key requirement – the quality of trials.
Therefore, on behalf of all EBA businesses, we thank the SEC, the Ministry of Health, and Arzinger (the legal partner of the EBA Clinical Trials Subcommittee), for their joint efforts in improving the regulatory environment for clinical trials in Ukraine, including drafting amendments to the Order.
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