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Clinical Trials, Health Care

19/ 10/ 2023
  In response to another appeal from the EBA Clinical Trials Subcommittee, the Ministry of Health prepared and published a draft Order On Amendments to Annex 7 to the Procedure for Conducting Clinical Trials of Medicines and Examination of Clinical Trial Materials, which proposes to remove the requirement to provide a copy of the accreditation certificate (AC) of the central executive body for a healthcare facility, and to submit it if available. Even before the full-scale war, the EBA persistently appealed to the SEC and the Ministry of Health with a proposal to regulate the rule on the mandatory provision of AC to bring it in line with the current requirements for the activities of health care facilities. Unfortunately, this provision on the mandatory provision of ACs during martial law has led to problems with approval and a reduction in the number of clinical trial sites that can be involved in conducting clinical trials due to CMU Resolution No. 362 of April 21, 2023, which simultaneously canceled the extension of the validity of ACs (which expired during the period of martial law or three months before the day of the introduction of martial law) for all healthcare facilities in Ukraine, although earlier the CMU Resolution No. 592 provided for the extension of the validity of ACs for another 12 months from the date of termination or cancellation of martial law, which in turn caused problems with the timely accreditation of healthcare facilities. Currently, the Order of the Ministry of Health dated 06.10.2023 No. 1745 with the relevant amendments to the Order of the Ministry of Health No. 690 is being registered with the Ministry of Justice. We thank the Ministry of Health for the effective cooperation!

In response to another appeal from the EBA Clinical Trials Subcommittee, the Ministry of Health prepared and published a draft Order “On Amendments to Annex 7 to the Procedure for Conducting Clinical Trials of Medicines and Examination of Clinical Trial Materials”, which proposes to remove the requirement to provide a copy of the accreditation certificate (AC) of the central executive body for a healthcare facility, and to submit it if available.

Even before the full-scale war, the EBA persistently appealed to the SEC and the Ministry of Health with a proposal to regulate the rule on the mandatory provision of AC to bring it in line with the current requirements for the activities of health care facilities. Unfortunately, this provision on the mandatory provision of ACs during martial law has led to problems with approval and a reduction in the number of clinical trial sites that can be involved in conducting clinical trials due to CMU Resolution No. 362 of April 21, 2023, which simultaneously canceled the extension of the validity of ACs (which expired during the period of martial law or three months before the day of the introduction of martial law) for all healthcare facilities in Ukraine, although earlier the CMU Resolution No. 592 provided for the extension of the validity of ACs for another 12 months from the date of termination or cancellation of martial law, which in turn caused problems with the timely accreditation of healthcare facilities.

Currently, the Order of the Ministry of Health dated 06.10.2023 No. 1745 with the relevant amendments to the Order of the Ministry of Health No. 690 is being registered with the Ministry of Justice.

We thank the Ministry of Health for the effective cooperation!

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