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The Electronic Common Technical Document (eCTD) is a standard format for submitting regulatory information to drug regulatory agencies around the world. The latest version of eCTD, eCTD 4.0, was released in 2022 and introduced several new features and significant improvements. It is used by pharmaceutical, biologics, and medical device companies to submit Regulatory applications to Health Authorities around the world. eCTD 4.0 offers many new advantages over previous versions (eCTD 3.2), including improved efficiency, increased usability, and enhanced compliance. The Japan PMDA is the first one to set a deadline of 2026 for the mandatory use of eCTD 4.0 for all new submissions, and other regulatory authorities e.g. US FDA, EMA, Health Canada and others, have also set similar deadlines in the coming years. 

The most significant changes in eCTD 4.0 are the introduction of forward compatibility and controlled vocabularies.

  • Forward compatibility: eCTD 4.0 submissions can be reviewed and processed by regulatory agencies that are still using eCTD 3.2.2. This is a major advantage for sponsors, as it allows them to submit their applications in the latest format without having to worry about whether the regulatory agencies will be able to review them.
  • Controlled vocabularies: eCTD 4.0 introduces controlled vocabularies, which are lists of approved terms that can be used to describe different aspects of a drug product. The use of controlled vocabularies in eCTD 4.0 will help ensure that the information in regulatory submissions is consistent and accurate. 

In addition to these major changes, eCTD 4.0 also includes several other improvements, such as:

  • Enhanced metadata: The metadata in eCTD 4.0 is more detailed and informative, which will help health authorities to more easily understand and process submissions. 
  • Improved usability: The user interface in eCTD 4.0 has been improved, making it easier for sponsors to create and submit eCTD submissions. 
  • Support for new technologies: eCTD 4.0 is designed to support new technologies, such as cloud computing and mobile devices. 

The introduction of eCTD 4.0 is a major step forward for the regulatory submission process. The new features and improvements in eCTD 4.0 will help to make the process more efficient, accurate, and secure. 

Here’s a quick snapshot of a few exceptional eCTD 4.0 benefits, including:

  • Efficiency: eCTD 4.0 streamlines the regulatory submission process, saving sponsors time and money. 
  • Accuracy: Controlled vocabularies in eCTD 4.0 ensure that regulatory submissions are consistent and accurate. 
  • Security: eCTD 4.0 is more secure than previous versions, making it less susceptible to fraud and data breaches. 
  • Technology: eCTD 4.0 supports new technologies, such as cloud computing and mobile devices, making it easier for sponsors to create and submit submissions from anywhere in the world. 
  • Communication: eCTD 4.0 improves communication between sponsors and regulatory authorities by providing a more collaborative review process. 
  • Compliance: eCTD 4.0 ensures that submissions are compliant with regulatory requirements by providing a more robust validation and translation process.

eCTD 4.0 US FDA and eCTD 4.0 Japan PDMA are accepting eCTD 4.0 voluntarily as of now. And the rest of the countries are in the process of implementation. Check out the eCTD 4.0 Implementation Dates.

The adoption of eCTD is a global effort to improve the efficiency and effectiveness of the regulatory review process for medicinal products. As more countries adopt eCTD 4.0 Submission, it will become the standard format for submitting Regulatory information worldwide. In a nutshell, the primary goals of eCTD 4.0 are to implement changes that speed up the Regulatory submission process, enhance how health authorities and sponsors communicate, and improve global harmonization of the format.

With this thought, we at Freyr, being at the forefront of driving innovation through advanced tech-enabled products, will be geared towards supporting our customers by soon adopting eCTD 4.0 in our Regulatory submission and publishing software - Freya.Submit. To Know More Request a Demo Today! 

Seamlessly Transition to eCTD 4.0 with Freyr

At Freyr, we are proud to be the strategic partner of choice for global pharmaceutical companies as they navigate the transition to eCTD 4.0. Leveraging deep regulatory expertise, we support end-to-end implementation starting with Japan and expanding across the United States and the European Union, ensuring seamless compliance with evolving global submission standards. 

Global eCTD 4.0 Implementation and Submissions 

Freyr is partnering with major pharmaceutical companies in Japan to support eCTD 4.0 submissions to the PMDA, including training, live submissions, and proof-of-concept (POC) activities—successfully delivering multiple submissions to date. 

As a recognized software partner, Freyr is working closely with the PMDA to provide technical consultation, ensuring full compliance with eCTD 4.0 Japan -specific requirements. 

Freyr is also supporting multiple clients with pilot submission for the eCTD 4.0 US FDA and is currently collaborating with EU Health Authorities on samples of eCTD 4.0 submission. 

Through strategic partnerships and regulatory expertise, Freyr is helping global pharmaceutical companies smoothly transition to eCTD 4.0—starting with Japan and expanding into the US and EU markets. 

eCTD 4.0 Competencies: Freyr vs Industry 

As of March 2025, Freyr is among the first to offer fully functional eCTD 4.0 submission capabilities and tools for the PMDA. 

To drive industry-wide readiness, Freyr is planning a nationwide eCTD 4.0 Industry Summit in Japan in Q3 2025. 

Freyr is also fully equipped to support global eCTD 4.0 transitions, with the US module ready by Q3 2025 and other regional modules on track for completion by the end of 2025.