On the initiative of the Verkhovna Rada of Ukraine Committee on Public Health, Medical Care and Medical Insurance, chaired by Mykhailo Radutskyi, in July 2022 the Law of Ukraine No. 2469-IX “On Medicinal Products” was adopted, which provides for the introduction of eCTD in Ukraine.
For three years, despite martial law, at the initiative of the Minister of Health of Ukraine Viktor Liashko, a number of necessary regulatory legal acts have been developed to implement the specified provision of the law.
By the IT teams of the Ministry of Health of Ukraine, Mariia Karchevych and the State Expert Center of the Ministry of Health of Ukraine with Mykhailo Babenko, a modern software product that meets EU requirements and is technically and procedurally convenient for business entities and experts was developed within a short time.
From January 1 to August 18, 2025, the submission of documents in eCTD format was voluntary, and from August 18, 2025, the submission of registration documents for new registrations in the international eCTD format is mandatory.
“The implementation of eCTD in Ukraine is an important stage of the digital transformation of the pharmaceutical sector in line with European Union standards, which will help improve the efficiency, transparency, and trust in regulatory authorities, reduce the burden on pharmaceutical market participants, shorten the timelines of registration procedures, and bring Ukraine closer to European standards for the regulation of the circulation of medicinal products. We are very grateful for the involvement, assistance, and support of the European Medicines Agency and personally its Executive Director #EmerCooke (Emer Cooke),” said Mykhailo Babenko.
Thus, as a result of the joint work of the Verkhovna Rada of Ukraine, the MoH of Ukraine, the EMA and the Center, with the active participation of pharmaceutical market stakeholders and international partners, despite the challenges of martial law, the implementation of eCTD in Ukraine took place much faster than in other European countries – in less than three years.
