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