The State Expert Center of the Ministry of Health of Ukraine has published for review and discussion the draft of a new version of the Module 1 eCTD specification for Ukraine, as well as the related technical materials.
The documents have been prepared as part of the further improvement and implementation of the electronic Common Technical Document (eCTD) format for submitting registration materials for medicinal products in Ukraine.
The draft of the updated Module 1 specification, in particular, takes into account:
- the requirements of the new Law of Ukraine "On Medicinal Products";
- the possibility of submitting periodic safety update reports for medicinal products (PSURs) in eCTD format.
For review and consideration, the following have been published:
- Module 1 (M1) eCTD Specification for Ukraine with recommendations on submitting registration dossier materials in the electronic eCTD format (draft);
- Appendices to the Module 1 eCTD Specification for Ukraine (draft);
- eCTD validation criteria for Ukraine (draft);
- Technical information for eCTD (draft).
The materials are posted on a dedicated page of the official website of the Center in the "For applicants" section – "DRAFT of a new version of the UA M1 eCTD specification".
We ask applicants and participants of the pharmaceutical market to review the published materials and, if any, to provide comments, remarks and suggestions.
When submitting suggestions, please indicate the relevant section or clause of the draft document and, where possible, provide a rationale for the proposed changes.
Comments, remarks and suggestions are accepted until 25 September 2026, inclusive at the email address: ectd@dec.gov.ua.
Further steps regarding the implementation of the updated version of the Module 1 eCTD Specification and the relevant technical materials will be announced additionally.
