The second online meeting on the implementation of eCTD in Ukraine was held at the Center. The aim was to answer questions from applicants received since the previous meeting and to discuss further steps in implementing eCTD in Ukraine.
The meeting was moderated by the Deputy Minister of Health for Digital Development, Digital Transformations and Digitalization Mariia Karchevych. The Center's team was led by Center Director Mykhailo Babenko, and deputies and heads of structural units also took part in the discussion – more than 20 specialists in total.
About 250 participants joined from the market side: applicants, representatives of the pharmaceutical business, foreign partners, and the media.
At the beginning of the meeting, Mariia Karchevych thanked those present for their willingness to join the joint meeting and stressed that such discussions provide an opportunity to hear and take into account the proposals and comments of different parties. For his part, Mykhailo Babenko noted that since the last meeting, the Center's specialists have done a large amount of work, in particular, they have analyzed and prepared answers to market questions and taken technical comments into account.
Artem Klieb, Head of the Information Technology Department of the Center, gave a presentation to those present. In his report, he noted that the Center had received almost 50 written questions, each of which was given a written answer. Also, following the processing of the proposals received, the draft M1 specification for Ukraine (with recommendations for the submission of materials) and the validation criteria have already been updated.
In the block devoted to answers to questions from the market, the greatest interest was aroused by the question of whether the submission of a Baseline submission (basic submission) is mandatory in Ukraine, and what materials should be included in such a submission. After an active discussion, it was decided to return to this issue additionally.
The next steps toward implementing eCTD in Ukraine include:
- approval of the M1 specification for Ukraine with recommendations on submission of materials and validation criteria;
- preparation, sending to stakeholders, and posting on the official website of the Center of technical service files based on the approved specification M1 for Ukraine and validation criteria;
- modernization of the software taking into account the approved M1 specifications for Ukraine and validation criteria;
- involving participants who wish to take part in submitting eCTD during the test period;
- launch of the test period and further work with applicants.
We remind you that, in accordance with the eCTD Implementation Roadmap, the test period for submission of registration dossier materials under the registration procedure for medicinal products is planned from 01 May 2024, and under the re-registration and amendment procedures from 01 July 2024.
The third meeting on the development of the eCTD dossier submission format in Ukraine is planned in just 1,5-2 weeks – two blocks of issues will be discussed, relating to the test period and the implementation of the eCTD system.
