eCTD 4.0: Implementation Best Practices

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With the standard constantly evolving across the pharma sector, the latest version can help bring benefits to the regulatory process.

Sadia Ahmed

Sadia Ahmed

The creation of the electronic common technical document (eCTD) revolutionized the pharmaceutical regulatory submission process. It enabled the phasing out of paper-based processes, bringing much needed speed, reliability, and efficiency to global regulatory submissions. As the standard format for submitting regulatory applications, supplements, and amendments, eCTD is accepted by health authorities around the world, such as Canada’s Health Canada, the US FDA, the European Union’s EMA, and Japan’s PMDA. The standard constantly evolves to meet the shifting demands of both regulatory bodies and the pharmaceutical space, and the latest version of the standard, eCTD 4.0, is poised to bring many eagerly anticipated benefits to the regulatory submission process.

The benefits include feasibility of collaboration between sponsors and health authorities via messaging capabilities, document reuse, better metadata and keyword definition, improved structure, accelerated approval timelines, faster global market access to cutting-edge products and a singular format for submissions across multiple regulatory agencies and regions. The initial draft implementation guidelines for eCTD 4.0 were developed in 2015 and 2016, and after many years of collaboration between regulatory bodies and sponsors, the mandatory implementation dates are almost here.

The initial deployment of eCTD (v3.0) standard required substantial efforts from sponsors, vendors, and agencies alike to drive adoption, and as the latest version becomes a reality, there are certain key factors that organizations must take into consideration when preparing for implementation, particularly for supporting multiple regions.

Regional differences

There are differences in both implementation and acceptance when a standard is introduced across multiple regions. The variations may include differences in metadata and control vocabularies (CVs), submission structure (M1 – M5), language and character support, group or work-sharing submissions, study standards, group title transition, and forward compatibility.

The timelines for implementation also vary by region, with mandatory dates ranging from now until 2029 and beyond. The dates per region can be found below.

The best practices for success

The people, strategies, processes and technologies involved play a role in the success of eCTD 4.0. To adequately prepare for the implementation, organizations should follow specific best practices:

  • Perform early assessments: Teams should conduct a full evaluation of current regulatory compliance systems, processes and documentation to streamline global submission workflows.
  • Maintain regulatory intelligence: Consistent review of regulatory agencies’ websites and attendance at industry events are essential for remaining current with shifting standards.
  • Provide training and skill development: The members of the regulatory team must be trained in all eCTD 4.0 terminology, concepts and new submission processes.
  • Take advantage of early adoption: Through engagement with technical pilots or small-scale sample submissions, organizations can assess conformance and readiness for adoption.
  • Standardize data: Leveraging standardized, user-defined metadata and vocabulary will help teams to maintain accuracy and consistency within submissions.
  • Update systems and software: eCTD publishing tools, submission tracking and document management systems must be compatible with and support eCTD 4.0 requirements.
  • Interact with regulatory bodies: Actively engage with regulatory agencies, participate in workshops and seek guidance for questions or concerns.
  • Continuously improve: Consistently assess and improve training programs, document templates and submission processes based on feedback received, lessons learned and industry best practices.
  • Maintain documents: Documentation must be current and thorough throughout the transition.

While eCTD 4.0 aims to meet the demands of the industry, success hinges on careful implementation and preparation. To ensure that regulatory processes are transitioned properly, adherence to these best practices is key. It is also critical to note that, in addition to the above approaches, continued support of the previous eCTD version—3.x—is required until 4.0 is mandatory across all regions. Organizations will be unable to remain current on necessary regulatory procedures unless they have this solid foundation to build upon.

The future is bright

As the adoption of the eCTD 4.0 standard increases globally, there will be greater standardization and harmonization of regulations. The space will continue to evolve, and the dynamic submission standards will adapt to meet the developing needs of the environment. Two-way communication capabilities will expand, allowing for even more data exchange and collaboration between sponsors, agencies and stakeholders, and more advanced analytics and reporting capabilities will emerge.

eCTD 4.0 is an essential step for streamlining the regulatory submission process, and a comprehensive understanding of the best practices is necessary to maximize its potential.

About the Author

Sadia Ahmed is product manager, regulatory technology, at IQVIA. She leads the team responsible for RIM Smart Submission Management, with over 20 years of experience in the IT and life sciences industry.

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