Overview of the electronic Common Technical Document (eCTD): EU Experience and Prospects for Implementation in Ukraine

22/ 06/ 2023

On June 14, 2023, a webinar on the experience of implementing eCTD in the EU took place. The event featured speakers Teresa Eastwood-Kiefer, Senior Global Team Leader of RSG Group at F. Hoffmann-La Roche, Switzerland; Martin Luht, Regulatory Submission Manager at F. Hoffmann-La Roche; and Yevhen Kudriavets, Senior DRA Specialist at Roche Ukraine LLC. The session was moderated by Dmytro Lurye, Manager of the Healthcare Committee at the European Business Association. The webinar gathered representatives from domestic and international pharmaceutical companies, service providers in the field of drug registration, as well as experts from the European Union who shared their experience and knowledge on the implementation of eCTD in EU countries. During the event, the advantages of the electronic format compared to the traditional paper-based approach to document submission were discussed. The webinar participants received comprehensive information about creating, preparing, and submitting electronic technical documents under eCTD standards. The experts thoroughly examined the stages of implementing the eCTD system using examples from certain European Union countries. Special attention was given to topics such as eCTD Life Cycle dossiers (which distinguishes the eCTD format from the more simplified NeeS - Non-eCTD electronic Submissions format), eCTD standards and specifications in the EU, as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The experts also discussed best practices, such as the Baseline requirements for submitting dossiers in the eCTD format for products registered in paper form (i.e., their digitization). Representatives from F. Hoffmann-La Roche explained to the participants how components of eCTD, such as attribute and metadata file viewing, as well as communication sequences between the applicant and regulatory authorities, function. Additionally, during the webinar, representatives from F. Hoffmann-La Roche demonstrated the eCTD system used by the company, allowing participants to witness the corresponding process in real-time. Furthermore, a representative from Roche Ukraine shared their experience of participating in the prior-testing of the eCTD system, which is currently being developed and implemented by the State Expert Center of the Ministry of Health of Ukraine. They discussed the particularities of the Ukrainian approach to the requirement of applying a qualified electronic signature to relevant documents. The participants of the webinar expressed hope that the recommendations and suggestions from European experts will be taken into account before the start of a full-scale pilot project. Following the presentations and speeches by the experts, a lively discussion took place, during which webinar participants had the opportunity to ask questions and discuss potential challenges and obstacles that arise during the implementation of eCTD in Ukraine. The need for defining an adequate transitional period for the system implementation for regulatory authorities and applicants was also discussed. The European Business Association emphasizes its support for the initiative to implement the electronic format eCTD in Ukraine, as it will improve the efficiency of the drug registration process and simplify communication between pharmaceutical companies and regulatory authorities. The association is also grateful to Roche company and the experts for conducting a fruitful and engaging webinar.

On June 14, 2023, a webinar on the experience of implementing eCTD in the EU took place. The event featured speakers Teresa Eastwood-Kiefer, Senior Global Team Leader of RSG Group at F. Hoffmann-La Roche, Switzerland; Martin Luht, Regulatory Submission Manager at F. Hoffmann-La Roche; and Yevhen Kudriavets, Senior DRA Specialist at Roche Ukraine LLC. The session was moderated by Dmytro Lurye, Manager of the Healthcare Committee at the European Business Association.

The webinar gathered representatives from domestic and international pharmaceutical companies, service providers in the field of drug registration, as well as experts from the European Union who shared their experience and knowledge on the implementation of eCTD in EU countries. During the event, the advantages of the electronic format compared to the traditional paper-based approach to document submission were discussed.

The webinar participants received comprehensive information about creating, preparing, and submitting electronic technical documents under eCTD standards. The experts thoroughly examined the stages of implementing the eCTD system using examples from certain European Union countries. Special attention was given to topics such as eCTD Life Cycle dossiers (which distinguishes the eCTD format from the more simplified NeeS – Non-eCTD electronic Submissions format), eCTD standards and specifications in the EU, as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The experts also discussed best practices, such as the “Baseline” requirements for submitting dossiers in the eCTD format for products registered in paper form (i.e., their digitization). Representatives from F. Hoffmann-La Roche explained to the participants how components of eCTD, such as attribute and metadata file viewing, as well as communication sequences between the applicant and regulatory authorities, function.

Additionally, during the webinar, representatives from F. Hoffmann-La Roche demonstrated the eCTD system used by the company, allowing participants to witness the corresponding process in real-time.

Furthermore, a representative from Roche Ukraine shared their experience of participating in the prior-testing of the eCTD system, which is currently being developed and implemented by the State Expert Center of the Ministry of Health of Ukraine. They discussed the particularities of the Ukrainian approach to the requirement of applying a qualified electronic signature to relevant documents.

The participants of the webinar expressed hope that the recommendations and suggestions from European experts will be taken into account before the start of a full-scale pilot project.

Following the presentations and speeches by the experts, a lively discussion took place, during which webinar participants had the opportunity to ask questions and discuss potential challenges and obstacles that arise during the implementation of eCTD in Ukraine. The need for defining an adequate transitional period for the system implementation for regulatory authorities and applicants was also discussed.

The European Business Association emphasizes its support for the initiative to implement the electronic format eCTD in Ukraine, as it will improve the efficiency of the drug registration process and simplify communication between pharmaceutical companies and regulatory authorities. The association is also grateful to Roche company and the experts for conducting a fruitful and engaging webinar.