eCTD

eCTD stands for “electronic Common Technical Document”. It is an electronic format for submitting regulatory information related to the development, registration, and marketing of pharmaceutical products. The eCTD is a standard format that allows pharmaceutical companies to submit regulatory information electronically, rather than in paper form.

The eCTD is based on the same structure and organization as the paper-based CTD, but it is in an electronic format that can be submitted to regulatory agencies via electronic submission portals. The eCTD provides several advantages over paper-based submissions, including:

1. Increased efficiency: Electronic submissions can be processed more quickly and efficiently than paper-based submissions, which can reduce the time and resources required for regulatory review.
2. Improved accuracy: Electronic submissions can help to eliminate errors and inconsistencies that can occur with paper-based submissions.
3. Enhanced accessibility: Electronic submissions are more easily accessible and can be easily shared and reviewed by multiple parties.
4. Reduced costs: Electronic submissions can reduce the costs associated with printing, shipping, and handling paper-based submissions.

The eCTD consists of a set of electronic files organized into five modules, corresponding to the modules of the paper-based CTD. These files are formatted according to the International Conference on Harmonization (ICH) guidelines and contain all of the information required by regulatory agencies to evaluate the safety, efficacy, and quality of a pharmaceutical product.

The use of eCTD has become increasingly widespread in recent years, with many regulatory agencies requiring or strongly encouraging electronic submissions. As such, it is important for pharmaceutical companies to be familiar with the eCTD format and requirements, and to ensure that their submissions are properly formatted and organized for electronic submission.

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