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