On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), have become effective. Below you can review the summary of introduced changes to be considered when conducting clinical trials in Ukraine.
Ministry of Health (MoH) and State Expert Center (SEC) submissions:
- As per the changes, the MoH approval for each clinical trial will now contain, amongst other information, the name of the entity or person authorized by the sponsor or clinical trial applicant to import study drugs and ancillary products. The purpose of this change is to reflect the affiliation of the importer with the specific clinical trial, which is usually required by the customs authorities during the customs clearance. This change should be considered during initial submissions, as there is a possibility that importers that are not indicated in the MoH’s approval will not be able to successfully perform customs clearance, and the submission of a substantial amendment will be required to cover new importers.
- In addition to the name of the importer, the MoH approval will include the principal investigator’s name. To ensure compliance with personal data laws, the new version of the Procedure supplements the template of the declaration of the principal investigator (Annex 6 of the Procedure) with the investigator’s agreement for processing his/her personal data by the MoH’s and SEC’s representatives and the placement of such data on the official websites of both referred entities. Please note that in case you are currently in the stage of preparing an initial submission of the study or the submission of additional sites (in both cases mentioned declaration should collected), you must obtain updated declarations as per the new template. This also applies to the declarations signed by the investigators before 31 December 2015 but not yet submitted. Please note that this amendment also applies to Local Ethics Committees submissions.
- The Procedure describes that in case of a substantial amendment, the applicant should submit the application for the substantial amendment along with the cover letter to MoH, while the rest of the materials should be submitted to the SEC. Previous version of the Procedure did not contain such clarification, which frequently resulted in uncertainties during the submission of substantial amendments.
- For bioequivalent studies, the amended Procedure allows applicants to not provide accreditation certificates for the hospitals in case the latter do not possess such certificates. Hospitals conducting any other clinical trials should still have valid certificate for submission purposes.
Local Ethics Committee (LEC) submissions:
- When submitting the clinical trial application to LEC, the sponsor or the applicant should now provide the copy of the protocol in its original language along with the protocol synopsis in Ukrainian. Earlier, only the protocol synopsis in Ukrainian had to be submitted, although many applicants usually opted to provide the entire protocol for LEC’s consideration.
- The applicants should now submit the copy of the insurance certificate to LEC. Please note that it is not required to provide the entire insurance agreement. The Procedure does not specify that the amended certificate (in case it undergoes any changes) shall be submitted to LEC.
- The timelines for a review of materials of substantial amendment by LEC have been increased from 10 to 15 calendar days. Please also note that, as practice shows, the State Expert Center may check during site inspections if the timelines are followed by LEC.
Other key changes
Beginning 31 December 2015 all clinical trials should be introduced into the list of clinical trials (the “List”) before the inclusion of the first patient. MoH will publish such list on its official website. The further statement in the Procedure confirms that the introduction of the data into the List is to be made for information purposes only. The scope of information to be published on MoH website about the study is not specified; however, considering the latest approaches, we expect that the full scope of information of MoH’s approval will be made available. It is also expected that the customs authorities will use the List for customs clearance purposes.
Please also note that although the wording mentions that a clinical trial shall be introduced into the List before the first patient inclusion, the Procedure does not refer to this activity as a prerequisite for the beginning of the study. Hence, the introduction of the trial in the List should not be deemed as a country-specific requirement for the start of patient enrollment.
Chapter IX of the Procedure now contains the clarification that the import of the study drug and ancillary materials may be performed by the sponsor, applicant and/or the entity or a person which is authorized by the sponsor or the applicant through the power of attorney to perform such import of study drugs (with or without marketing authorization) and ancillary products (medical devices, medical equipment, etc.). It may be reasonable to reflect the wording of this provision in the power of attorney to mitigate the risks of unnecessary delays during customs clearance. At the same time, the wording in the Procedure does not provide any leeway for cases when the power of attorney was issued not by the sponsor or the applicant, but, for example, by the sponsor’s affiliate or manufacturing site. The possibility of importers to perform the customs clearance in such cases should be further clarified.