Through Order No. 1789 of 13 October 2023 (as further amended by the Order of the Ministry of Health of Ukraine No. 1924 of 8 November 2023), the Ministry of Health of Ukraine (MoH) inter alia introduced the option of submitting registration dossiers for medicinal products in electronic Common Technical Document (eCTD) format. MoH made corresponding amendments to the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products, approved by MoH’s Order No. 426 dated 26 August 2005 (Procedure).
Additionally, the Order No. 1789 introduces changes to the Procedure harmonising its terminology as well as amending the general procedure for medicinal products registration materials’ expert evaluation.
The Common Technical Document (CTD) is an internationally agreed-upon format of registration dossier for the assessment and authorisation of new medicines, as well as for post-authorisation submissions. The CTD format is developed and maintained by the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use.
eCTD is the electronic format of CTD, which enables electronic interactions between pharmaceutical companies and regulatory bodies, and electronic document flow at the level of regulatory bodies.
eCTD is mandatory in the EU, Japan, Switzerland, Canada, and the US, and has been adopted as a standard format for regulatory submissions by stringent regulatory authorities in other jurisdictions.
Beginning 1 May 2024, the Procedure defined above allows the submission of the registration dossier in eCTD format in Ukraine. The State Expert Centre (SEC), the regulatory body under the MoH, will begin assessing dossiers in eCTD format in a test mode.
To ensure the successful launch of the eCTD:
- By 1 February 2024, the SEC will develop the specification of eCTD and validation criteria.
- By 1 June 2024, the SEC must implement appropriate eCTD software and validate its compliance with the specification and validation criteria.
The adoption of eCTD standard:
- Facilitates exchange and review of registration information by the regulatory body.
- Reduces the time and costs for preparation and submission of registration materials.
- Ensures consistency and completeness of the registration dossier.
- Enhances the assessment process at the level of the regulatory body and provides for more transparency and accountability.
Order No. 1789 also specifies that up until eCTD format becomes mandatory:
- The applicants will be free to choose between eCTD and paper/electronic format for the dossier submission for registration, renewal of registration, or variations.
- When submitting registration materials in eCTD format, paper copies will not be required.
According to the presented roadmap for eCTD implementation, the MoH plans to make eCTD submission mandatory from August 2025.
Furthermore, as specified in a separate amendment to the Procedure, the regulatory body will not recommend that the MoH decide on the registration (i.e. marketing authorisation) of a medicinal product if any of its stages of manufacturing, including development and clinical trials (if initiated after 24 February 2022), have been conducted by enterprises located in Russia or Belarus.
This represents another step towards harmonising Ukrainian legislation with the EU laws by means of approximation of the above-mentioned regulations inter alia to EU Directive 2001/83/EC.
For more information on the introduction of the eCTD standard in Ukraine, contact your CMS client partner or these CMS experts: Borys Danevych, Anna Pogrebna.