An electronic common technical document (eCTD) is a standardized format for submitting regulatory information to regulatory agencies. It is based on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on electronic submissions.
The eCTD is a digital package of documents that contains information on the development, manufacturing, and testing of pharmaceutical products. It includes detailed information on the drug substance, drug product, clinical trials, and the results of those trials. The eCTD is designed to simplify the submission process, reduce the need for paper submissions, and make it easier for regulatory agencies to review and approve submissions.
The eCTD is a structured format that follows a specific hierarchy of sections and subsections. It generally consists of five modules, each containing specific information:
1. Module 1: Administrative Information – This module contains administrative information such as the cover letter, application form, and regulatory affairs information.
2. Module 2: Common Technical Document Summaries – This module provides an overview of the application, including a table of contents, summaries of the quality, safety, and efficacy data.
3. Module 3: Quality – This module contains detailed information on the drug substance, drug product formulation, manufacturing process, and controls.
4. Module 4: Nonclinical Study Reports – This module contains detailed information on toxicology studies and other nonclinical studies conducted on the drug.
5. Module 5: Clinical Study Reports – This module contains detailed information on the clinical studies conducted on the drug, including study protocols, patient data, and the results of the studies.
The eCTD format makes it easier to manage, track, and review submissions. It also allows for faster review times and more efficient use of resources. Regulatory agencies can easily access and track submissions, and review and compare information across different submissions.
In summary, the eCTD is a standardized format for submitting regulatory information to regulatory agencies. It is designed to simplify the submission process, reduce the need for paper submissions, and make it easier for regulatory agencies to review and approve submissions. The eCTD format allows for faster review times and more efficient use of resources, benefiting both the pharmaceutical industry and regulatory agencies.