eCTD, GMP Conclusions, and implementation of the law “On Medicinal Products”: Meeting of the Registration Subcommittee of the Health Care Committee of the EBA

05/ 08/ 2025

On 29 July, the Registration Subcommittee of the Health Care Committee of the European Business Association held a meeting that brought together over 80 participants, representatives of the pharmaceutical industry, regulatory authorities, and the expert community. During the hybrid-format session, participants discussed the most pressing issues in the sector, including the implementation of the eCTD format, the process of obtaining GMP Conclusions, and key aspects of enforcing Law No. 2469-IX “On Medicinal Products.” A central focus of the meeting was the introduction of the eCTD dossier submission format in Ukraine, which marks a fundamental change in the registration procedure for medicinal products. Invited representatives of the State Expert Centre of the Ministry of Health of Ukraine joined the discussion, providing participants with direct regulatory insights and clarifications. The Health Care Committee served as an effective platform for meaningful dialogue, exchange of views, and addressing the practical questions raised by businesses. Special attention was also given to the procedure for obtaining GMP Conclusions. Participants highlighted a number of issues that require improvement, discussed possible ways to optimise relevant processes, and agreed on next steps to communicate their proposals to the appropriate state authorities. The meeting also covered the implementation of Law No. 2469 “On Medicinal Products”. Participants identified key priorities for further work, with a focus on the practical aspects of its implementation. For the first time in a while, the session was held in a hybrid format with in-person attendance. This created opportunities for informal networking, experience sharing, and productive discussion of regulatory changes and their real-world application.

01/

A central focus of the meeting was the introduction of the eCTD dossier submission format in Ukraine, which marks a fundamental change in the registration procedure for medicinal products. Invited representatives of the State Expert Centre of the Ministry of Health of Ukraine joined the discussion, providing participants with direct regulatory insights and clarifications. The Health Care Committee served as an effective platform for meaningful dialogue, exchange of views, and addressing the practical questions raised by businesses.

Special attention was also given to the procedure for obtaining GMP Conclusions. Participants highlighted a number of issues that require improvement, discussed possible ways to optimise relevant processes, and agreed on next steps to communicate their proposals to the appropriate state authorities.

The meeting also covered the implementation of Law No. 2469 “On Medicinal Products”. Participants identified key priorities for further work, with a focus on the practical aspects of its implementation.

For the first time in a while, the session was held in a hybrid format with in-person attendance. This created opportunities for informal networking, experience sharing, and productive discussion of regulatory changes and their real-world application.