Common Technical Document and eCTD
Common Technical Document (CTD) and eCTD is a standardized format for submitting regulatory documentation for the registration of pharmaceuticals, veterinary medicines, and medical devices in the European Union (EU) and other regions such as Japan. The CTD format was developed to harmonize the submission process and reduce the burden on applicants by providing a clear and consistent structure for regulatory submissions.
The CTD provides a framework for the development of a consistent, complete, and high-quality submission that is globally acceptable to regulatory authorities.
The CTD format consists of five modules, each containing specific information about the product being submitted for approval:
- Module 1: Administrative information and prescribing information
- Module 2: Quality overall summary
- Module 3: Non-clinical study reports
- Module 4: Clinical study reports
- Module 5: Quality information for the regulatory authorities
Electronic Common Technical Document (eCTD) is an electronic version of the CTD format. It is an increasingly popular method for submitting regulatory submissions, as it offers several benefits over traditional paper-based submissions, including improved efficiency, increased accuracy, and reduced processing time. In addition, the use of eCTD enables regulatory authorities to access information more quickly and easily, facilitating the review process.
To summarize, the CTD and eCTD are standard formats for submitting regulatory documentation for the approval of pharmaceuticals, veterinary medicines, and medical devices. The CTD format provides a clear and consistent structure for regulatory submissions, while the eCTD format offers several benefits over traditional paper-based submissions.
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