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 a number of new features and improvements. It is used by pharmaceutical, biologics, and medical device companies to submit Regulatory applications to Regulatory authorities around the world. eCTD 4.0 offers a number of advantages over previous versions, including improved efficiency, increased usability, and enhanced compliance. The EMA has set a deadline of 2024 for the mandatory use of eCTD 4.0 for all new submissions, and other regulatory authorities are expected to 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 or not 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 to ensure that the information in regulatory submissions is consistent and accurate.

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

  • Enhanced metadata: The metadata in eCTD 4.0 is more detailed and informative, which will help regulatory agencies 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.

There are a number of benefits to using eCTD 4.0, 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.

US FDA and Japan PMDA are accepting eCTD 4.0 voluntarily as of now. And rest of the countries are in the process of implementing. 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 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 Agencies 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 - Freyr SUBMIT PRO. To know more about it Request a demo Today!