By Nirpal Virdee, Global Head of Transparency & Disclosure
Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in parliament in 2017 allowed for a transformational healthcare sector to open its state run services to a business friendly, collaborative environment for public/private partnerships. In parallel to high quality medical services there has also been a drive to transform the regulatory submission process.
Ministry of Health of Ukraine Order 1528
Additionally, the MoH released a new procedure for the disclosure of both pre-clinical and clinical data disclosure. This came in to effect in June, 2019 under Order 1528. Under this law, the MoH is required to publish pre-clinical and clinical reports for all medicines on a public facing portal.
What’s in Scope?
- During the registration of the dossier, MoH requires sponsors to submit pre-clinical and clinical data in pre-defined forms with a cover letter that has been developed by the authority.
- This only applies to submissions after August, 2019 for standard and accelerated procedures only.
- Submission of the forms are voluntary for variation registrations before August, 2019.
Approval Timelines
For the standard registration procedure, expert review is 210 days and the total timeline spans 18-24 months. If approval has already been gained in other specified regulatory agencies, the accelerated procedure expert review is 45 days and the total timeline spans 8-12 months. The sponsor would be obligated to create their disclosure forms within this period.
Recommendations
Synchrogenix has supported sponsors with thousands of trial postings to global disclosure databases using a proven methodology. Based on years of experience ensuring sponsors maintain compliance through consulting, project leadership, remediation plan preparation, postings updates and completion, and process creation, we suggest the following in order to adhere to MoH Order 1528.
Recommended Approach
- In the cover letter, clearly state the sponsor’s agreement to disclose the data within the forms provided. Also confirm and explain why certain data was excluded and why certain trials may not have been conducted.
- Complete the forms using the templates provided by MoH and input information typically captured in the clinical study report synopses.
- Do not disclose any data that has not already been published in the public domain. Only provide information that has already been published to other global registries such as CT.gov or EudraCT.
- When completing the forms, do not include any personal identifiable information or company confidential information. There is no need to anonymize or redact these documents.
- Complete the forms in English and then have all forms translated to Ukrainian.
Deliverables
- Individual forms are required for each clinical study.
- One combined form is required for non-clinical studies.
What We’ve Learned So Far
Synchrogenix has already started supporting sponsors with Ukraine’s new provisions for public disclosure. Our expert regulatory teams have made the following observations.
- The MoH provides little guidance beyond providing the forms that are requested.
- The MoH is encouraging sponsors to do their best with the forms and will decide on standards once sponsor submissions are collectively reviewed.
- There is a different approach to the forms requested for clinical and non-clinical studies.
- We are yet to learn when and where these forms will be posted for public consumption.
- If you do not have pending submissions, consider a voluntary submission of the forms for a past submission to test and learn the process.
- Leave time in your process for translation.
Want more information? Contact us to speak with our regulatory experts.