Transition to eCTD from 1 January 2027: A New Digital Logic for Registration Procedures

On 1 January 2027, the main provisions of the new Law of Ukraine ‘On Medicinal Products’ No. 2469-IX will enter into force. One of the most significant practical changes will be the extension of dossier submission in electronic format to all registration procedures: new registration, re-registration, indefinite extension of state registration, and variations to the dossier.

The transition to digital processes not only changes the format of dossier submission and interaction with the regulatory authority during expert assessment, but also introduces new regulatory requirements and calls for updated knowledge and skills within the regulatory affairs department. eCTD is becoming not merely a submission format, but also a single digital environment in which the registration life cycle of each medicinal product will be maintained.

For Ukraine, this is an expected and consistent step towards alignment with the regulatory model of the European Union. Trial acceptance of materials for new registration began in May 2024, and on 18 August 2025 eCTD became mandatory for this procedure, subject to the established exceptions. According to information from the Director of the State Expert Center (SEC), Edem Adamanov, cited in a publication of ‘APTEKA Weekly’ dated 8 September 2026, the Center received 1,131 dossiers in eCTD format during 2025–2026.

The new legislation also implements the European model, in which the term ‘submission of an Application’ means the simultaneous submission of the Application and the registration materials (dossier). This model significantly reduces the interval between the emergence of a regulatory obligation and the submission of the complete dossier. For Applicants, this means a different approach to planning their work, particularly where submission deadlines are limited, for example, when the need for changes to the registration materials arises as a result of new safety information.

In this article, we will examine the national specificities of eCTD and their practical significance in the run-up to the transition to the new regulatory framework. This material was prepared as of 21 September 2026. We have taken into account current legislation and published drafts, but note that certain provisions may change before their approval.

What Is eCTD

eCTD (electronic Common Technical Document) is the electronic Common Technical Document. It retains the logic of the CTD: five modules cover administrative materials, summaries and overviews, quality, non-clinical and clinical data. The difference lies in how these materials are organised, formatted, submitted and updated.

eCTD is not simply an archive of PDF files. Documents are arranged in a prescribed structure and prepared in accordance with technical rules governing file formats, names, sizes and navigation. Backbone XML files, or XML backbones, contain formalised descriptions of the submission: metadata, references to documents and information about their updates. Version 3.2.2 uses the main ICH XML backbone for Modules 2–5 and the regional XML file for Module 1.

Each submission is prepared as a sequence, regardless of whether it concerns new registration, re-registration, variations or a response to questions raised during expert assessment. Subsequent sequences supplement the dossier already created rather than starting it anew. This creates a history of submitted documents and ensures continuity of the dossier’s life cycle. At the same time, a submitted version is not necessarily an approved version: the status of the regulatory procedure must be monitored separately.

The transition is particularly relevant to the day-to-day work of regulatory affairs departments in Ukraine’s current circumstances. The need to print and copy multi-volume sets disappears, while software helps to automatically generate the structure, metadata and navigation, and to check the technical correctness of the materials. However, preparing high-quality source documents and conducting a substantive review remain the responsibility of the specialist.

Dossiers and responses to questions can be submitted remotely through the Applicant’s Cabinet. This reduces the time spent on delivery and in-person visits and lessens dependence on the operation of the physical ‘single window’, including during air raid alerts, when specialists’ ongoing work is suspended.

Practical experience:

“One of the important advantages of eCTD-RIMS is the ability to perform preliminary technical validation of an electronic dossier even before it is submitted to the regulatory authority. […] Based on practical use of eCTD-RIMS, the time required for final assembly and publication of Modules 1–5 was reduced by approximately 40%.”

From feedback provided by Firm NOVOFARM-BIOSYNTEZ LLC

National Specificities and Differences of eCTD

The Ukrainian model is based on ICH eCTD version 3.2.2—the same international foundation used for European submissions. It is supplemented by the national specification UA M1 v1.2. The SEC publishes the specification, validation criteria, DTD, templates and the Applicant’s Cabinet user guide.

The common standard allows a significant part of the materials in Modules 2–5 to be reused, but it does not make the Ukrainian and European procedures identical. Ukraine requires its own life cycle, UUID and sequence numbering, Ukrainian Module 1 and a regional XML file, appropriate digital signatures, working documents, a tracking table and validation against national criteria. Consequently, a European dossier cannot simply be renamed and uploaded to the Ukrainian Applicant’s Cabinet.

Localisation also extends to content: manufacturing sites, dosages, other product characteristics and the versions of documents approved in Ukraine may differ from their European equivalents. The source dossier must be reconciled with the specific Ukrainian registration, rather than merely having its administrative part translated.

UUID for Submissions in Ukraine

The UUID identifies the dossier throughout its entire life cycle. It is generated when the first sequence, 0000, is prepared and is included in the regional XML file. Generation may be performed by eCTD preparation software.

A separate Ukrainian dossier is always assigned its own identifier; the UUID of a foreign submission is not copied. Even if a medicinal product from the same Applicant is submitted for registration in Ukraine using a ‘European’ dossier, or a national medicinal product is registered by packaging in-bulk products, the UUID for the new registration in Ukraine must be unique.

The same UUID is subsequently used in all sequences for the respective dossier, regardless of whether they concern a variation, re-registration or a response to questions.

National Module 1 and Working Documents

Module 1 is the regional part of the dossier, the requirements for which are approved at national level. Ukrainian rules determine the composition of administrative documents, cover letters, forms, medicinal product information and other local materials, while the eCTD specification determines their electronic placement and description. Changes to regulatory forms under the new Law will require corresponding technical implementation and an update to the UA M1 eCTD Specification, but do not in themselves remove the obligation to submit administrative information.

The ‘Working Documents’ folder is placed alongside the eCTD sequence. It contains editable copies in .docx format, including quality control methods (QCM), labelling texts, instructions for medical use, the summary of product characteristics and the risk management plan, as required by the relevant procedure. These copies are not described in the XML backbone and do not replace the PDF versions within the dossier structure. A working documents folder also exists in the EU. The Ukrainian specific feature is primarily its contents, in particular the inclusion of QCM as a separate national document.

Qualified Electronic Signature

Documents subject to an electronic signature requirement must be signed by a duly authorised person of the resident Applicant or the Applicant’s representative in Ukraine in accordance with the requirements of Ukrainian legislation on the use of a qualified electronic signature (QES). The application of a QES may be integrated into the eCTD software or performed through third-party services (including Diia) or in the Applicant’s Cabinet.

When documents from a dossier submitted in another country are used, some files may already contain a digital signature applied in that country, and the presence of such a file usually results in an error and rejection during automatic dossier validation after submission through the Applicant’s Cabinet.

Cover Letter and Sequence Tracking Table

A separate new requirement of the electronic format is a cover letter, which must be drawn up in Ukrainian and include a list of the documents being submitted, the number of files in the submission, the current sequence number and information on previous regulatory actions, confirmation that an antivirus scan has been performed using licensed antivirus software, and other information as required by the template. Preparing the list of documents and counting the number of files poses a particular challenge for the registration department, as performing these operations manually often becomes a separate, labour-intensive process. The same applies to preparing the Sequence Tracking Table, which is included as an annex to the cover letter and must contain information on the current sequence and all previous sequences.

The functionality for automatically generating such a cover letter and tracking table is an important component of eCTD software.

Separate State Registration of APIs

In the EU, an active pharmaceutical ingredient does not receive a separate marketing authorisation analogous to registration of a finished medicinal product. API documentation is assessed as part of the dossier for the finished product; for the relevant substances, the ASMF procedure or a certificate of suitability to the monographs of the European Pharmacopoeia (CEP) may be used. An ASMF may have its own technical life cycle, but this does not constitute separate registration of the substance.

In Ukraine, the new Law exempts APIs from mandatory state registration but retains the possibility of registering them at the Applicant’s request pursuant to clause 9 of part eight of Article 13 of the new Law. Accordingly, the Ukrainian eCTD technical model also provides for the possibility of new API registration and life-cycle maintenance.

Baseline Submission

A baseline submission is not a national specific feature, as it also exists in the EU. However, it may be appropriate for correctly and conveniently establishing the beginning of the life cycle of an electronic registration dossier in Ukraine.

It is neither a new registration nor a re-registration, is not intended for approval of new variations and does not undergo specialised expert assessment. A baseline submission is not mandatory and may be submitted either at the beginning of work in eCTD format or at any other point in the life cycle. A baseline submission in itself does not demonstrate that the dossier has been brought into compliance with the requirements of the new Law.

A baseline submission is particularly useful where approved materials are scattered across paper volumes and subsequent variations: it helps establish a clear electronic starting point.

What Changes from 1 January 2027

The new Law of Ukraine ‘On Medicinal Products’ explicitly provides that documents for state registration, re-registration and variations to the materials of a medicinal product’s registration dossier are to be submitted exclusively in electronic form.

At the same time, the current national UA M1 eCTD Specification version 1.2 was developed to meet the existing requirements and system of regulatory procedures. The new legislation changes Application forms, the structure of administrative data, the classification of variations and grouping rules. Therefore, an update to the national specification and validation rules is expected.

In addition to the technical update of the specification, the new Law substantially changes the procedure for submitting registration materials.

Submission of an Application Will Mean that the Materials Are Ready

Under the general mechanism of the current Procedure approved by MoH Order No. 426, submission of the Application is separate from submission of the complete set of materials. Between these two stages, the Applicant completes administrative steps relating to submission of the registration form, its processing, invoicing and payment.

Article 14 of the new Law, by contrast, provides for a transition to the European model of submitting the Application together with the registration materials (dossier). This approach is detailed for the relevant procedures in the draft Procedure for the Expert Assessment of Registration Dossier Materials published by the MoH for public consultation: the Application and the package of materials for the relevant procedure are submitted simultaneously. The existing separate ‘registration form’ stage is likely to disappear.

The consequence for the Applicant is significant: the date of submission of the Application ceases to be the date on which dossier preparation begins and becomes the date on which it is completed. This means that translations, local texts, administrative documents, electronic signatures, the eCTD structure and the results of technical validation must already be ready at the time of dossier submission.

The time previously available after the initial submission of the Application is shifted to the preparation stage.

Example: When Almost Six Months Become Two

The current Procedure No. 426 requires the Applicant to notify the SEC and submit an Application for safety-related changes to the instructions for medical use no later than 60 calendar days from the date on which information about the need for such changes is received. A practical example is a publication by the SEC concerning the need to update safety information in the instructions for medical use.

The subsequent submission of the complete package of registration materials must take place within three months of submission of the Application, with the possibility of a one-time, justified extension of up to 20 working days. If these maximum periods are notionally used, the total is approximately six months: 60 calendar days + approximately 90 calendar days + approximately 28 calendar days.

The published draft retains the 60-calendar-day period for safety-related variations but combines submission of the Application with submission of the registration materials. Thus, under this scenario, the time available to prepare the complete package will be approximately three times shorter.

The practical consequence is that safety assessment, agreement of texts, translation and technical preparation must take place in parallel. Starting eCTD training only after a time-limited obligation arises is risky: by that point, a trained team, access to up-to-date documents and software will already be required.

Validation and Preliminary Expert Assessment

The draft new Procedure for new registrations and re-registrations does not identify preliminary expert assessment as a separate stage in the form provided for by the current Procedure No. 426. eCTD technical validation checks the structure and files of a submission. At the same time, a positive result from this check does not in itself confirm the completeness of the materials for a specific procedure and does not replace their expert assessment.

Corrupted PDF files, a password required to open a file, invalid XML or inaccessible links may prevent technical acceptance of the package.

Electronic Submission of PSURs

The new Procedure for the Conduct of Pharmacovigilance, approved by MoH Order No. 740 of 3 June 2026, enters into force on 1 January 2027. It provides for submission of a periodic safety update report (PSUR, or ПОЗБ in Ukrainian), together with its annexes, in electronic form or in eCTD format where technically feasible. This is consistent with the European practice of electronic PSUR submission through a single repository.

Accordingly, the use of eCTD is also envisaged for a separate pharmacovigilance process. At the same time, the above wording does not establish an unconditional requirement to submit all PSURs exclusively in eCTD from the first day of 2027.

Readiness for eCTD and Invitation to Training

eCTD reduces routine work, costs associated with paper dossier sets and delivery, and makes remote submission standard practice. However, the benefit comes not from the mere transition to documents in electronic form but from the coordinated work of people, documents and software.

Applicants need sequence preparation skills, control over current versions and a clear allocation of responsibilities. Restructuring a company’s regulatory processes takes time and involves dedicated training of the team in the use of eCTD software, additional preparation of PDF files, checking the dossier structure, and agreeing on file naming rules and technical verification procedures.

Software developers are expected to have knowledge of national procedures, adapt promptly to new specifications, provide clear validation and deliver high-quality technical support. It is precisely this shared readiness that will allow short regulatory timeframes to be used for substantive work rather than correcting technical errors.

Practical experience:

“The user training provided was distinguished by its structured approach, substantive content and accessible presentation of the material, which made it possible for even those who had no previous experience working with eCTD documentation to quickly master the system’s functionality. […] We would also particularly highlight the high-quality technical support, including the availability of an effective telephone ‘hotline’ that provided assistance at all stages of working with the system.”

From feedback provided by FARMKHIM LLC—a leading Ukrainian manufacturer of active pharmaceutical ingredients and ‘in bulk’ products, which was among the first in Ukraine to introduce an electronic system for submission of registration materials. eCTD-RIMS

IRIS Soft, a Ukrainian developer of software for eCTD, pharmacovigilance and GMP/GDP process management, invites you to free online training on the updated eCTD-RIMS. To participate, advance registration is required.