The most popular Q&A session of the week discussed the introduction and implementation of eCTD v4.0. The panel featured:
Alastair Nixon, Director, Submission Standards, Global Regulatory Platform and Delivery, GlaxoSmithKline
Dr Bernd Misselwitz, Director, Regional Head of Regulatory Submission, Bayer
Rodrigo Palacios, PTR Global Head for Business Systems, Roche
The experts started the session by discussing how the eCTD v4.0 will work if it becomes mandatory in 2025. Alastair Nixon believes that the eCTD v4.0 could work right away, but currently there is a lack of drive for its implementation. He views the eCTD v4.0 as an apparently better way to do submissions, and while 2025 is the timeframe for its mandatory implementation, he hopes to see pilots already next year. Dr Bernd Misselwitz raised the need for a clearer communication with regulators from a European viewpoint. He believes regulators should commit to a roadmap and milestones for the eCTD v4.0 implementation because this will clarify the need and timing for different tools.
Next, the future of the eCTD in view of the restructured data submission was discussed. Rodrigo Palacios believes the eCTD v4.0 may help transform pieces of the dossier into structured data. In the more distant future, he envisions a discussion to identify the most “fit for purpose” way to exchange data with regulators. The participants agreed that, since the eCTD requirements were developed in 2008, it is time to brainstorm for ways to move forward, considering the new developments, including cloud technologies, reliance pathways, etc.
The experts discussed strategies to accelerate the global implementation of eCTD v4.0. Dr Misselwitz reiterated the need for clear timelines and tools for the eCTD v4.0 implementation. He also mentioned the chance to introduce the eCTD v4.0 into countries that are currently looking to move to electronic submission standards. Rodrigo Palacios stressed the importance of infrastructure, specifications and policies set up by regulators, and leveraging the power of new technologies to facilitate the global eCTD v4.0 implementation.
Alastair Nixon emphasised the need for a drive in countries using the eCTD format to move toward eCTD v4.0. This may also be a motivator for countries looking to newly develop an electronic submission system to join the eCTD format instead of developing an alternative electronic submission system.
Another topic of discussion was how to optimise eCTD data management. Rodrigo Palacios emphasised the need for strong data management in companies. For example, Roche works to raise employees’ awareness of data management by introducing the “data citizenship” initiative. There is a need to start a knowledge journey in order to update and automate practices and technology to track the data from origin to submission.
The experts concluded the session with their final takeaways. Alastair Nixon emphasised the need for a more specific milestone European Union roadmap for eCTD v4.0 implementation. Rodrigo Palacios believes that a strategic view is needed in order to take advantage of the features of the eCTD v4.0 standard: two-way communication, granularity, and ability to reuse and update documents across applications.
The guidelines and policies of the regulator and the end-to-end process should be looked at to make the process more efficient. Since the implementation of this very new standard will require a lot of time and effort to implement, its benefits should be utilised. Dr Misselwitz explained that better communication and promotion of the eCTD 4.0 is needed, including by the EMA. In parallel, alternative standards should be looked at for the future.
