The Therapeutic Goods Administration (TGA) is advancing its implementation of the ICH eCTD (Electronic Common Technical Document) version 4.0, aiming to enhance global harmonization and streamline regulatory submissions.

While the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have already taken substantial steps toward eCTD v4.0 adoption, Australia has, until recently, remained in the earlier version 3.2.2 framework. With its structured roadmap now underway, TGA is catching up with its international counterparts by modernizing its submission infrastructure and embracing a more robust, interoperable, and flexible regulatory framework.

The following sections dive into the details of TGA’s implementation timeline, current progress, and the key considerations regulatory professionals should keep in mind as they prepare for the shift.

TGA’s eCTD v4.0 Implementation Timeline and Status

Current Status and Key Updates

As TGA works toward the full implementation of eCTD 4.0, it’s important for regulatory professionals to stay informed about the latest developments. Understanding the current status of the rollout and the key updates will help you navigate the transition and prepare effectively. Below is an overview of the progress made so far:

• Stages 1 and 2 Completed: The TGA has successfully completed the initial stages of the eCTD v4.0 transition. This includes industry consultations, which took place in late 2023, and a thorough internal review of the outcomes in Q1 2024. These consultations played a vital role in gathering feedback from stakeholders, ensuring the Australian approach aligns with global standards.
• Stage 3 – Publication of Module-1 v4.0: Initially planned for earlier in 2024, the release of Module-1 v4.0 has been delayed.
• Stages 4 and 5 – Technical Pilot Program: Invitations for participation in the Technical Pilot Program have not yet been issued as of April 2025. The TGA is in the process of preparing the necessary infrastructure and systems to support the program, which is expected to commence around Q3 2025. This pilot will allow participants to experience eCTD v4.0 in real-world conditions and provide feedback on its functionality.
• Stage 6 – Voluntary Adoption: Following the technical pilot, the TGA plans to introduce a voluntary adoption phase for eCTD v4.0, expected to begin in 2026. This will give sponsors the flexibility to transition to the new system ahead of the mandatory requirement.
• Stage 7 – Mandatory Adoption: The mandatory adoption phase is still being finalized, with a date to be determined. Once implemented, sponsors will be required to submit all regulatory dossiers via eCTD v4.0, ensuring that the industry operates in line with the updated global regulatory framework.

Next Steps for the Life Sciences Industry

As the TGA progresses through each stage of the eCTD 4.0 rollout, there are several actions that regulatory professionals can take now to ensure they’re prepared for the upcoming changes. Proactive engagement with the process will ease the transition to the new system and help avoid any disruptions in compliance. Consider the following next steps:

• Monitor TGA Communications: Stay updated by frequently checking the TGA’s official website and communications. This will ensure you are informed about new developments, timeline shifts, and the availability of key resources such as guidance documents and Module-1 v4.0 once published.
• Prepare for the Pilot Program: As the Technical Pilot Program is expected to begin in late 2025, prepare your organization by reviewing internal processes and considering participation. Engaging in the pilot phase will provide valuable insights into how eCTD v4.0 operates and offer a head start in adapting to the new submission format.
• Review Internal Systems: Assess your organization’s submission infrastructure to identify any necessary updates. eCTD v4.0 requires enhanced data management capabilities, so ensuring your systems are aligned with the new technical specifications will help streamline the transition when it becomes mandatory.
• Engage with TGA Resources: Leverage the support and guidance offered by the TGA during this period. The TGA is expected to provide ample resources, such as webinars, FAQs, and detailed documentation, to help sponsors align with the new eCTD 4.0 requirements. Stay in touch with TGA’s technical support channels to address any concerns or queries.
• Train Your Team: As eCTD v4.0 will bring about changes in regulatory submission workflows, it’s essential to train your internal team on the new system. This includes familiarizing them with the updated submission format, understanding new technical requirements, and ensuring they are well-prepared for the transition.

For further information and updates, refer to the TGA's dedicated page on the implementation of the ICH eCTD v4.0 specification.

By staying informed and proactively preparing for these changes, regulatory professionals can ensure a smooth transition to eCTD v4.0 and maintain compliance with evolving submission standards.