What is Electronic Common Technical Document (eCTD)?
Regulatory submissions are an important aspect of drug development and approval in the pharmaceutical industry. Electronic Common Technical Document (eCTD) has been developed to standardize and simplify the process of providing information to regulatory bodies. The eCTD is an internationally recognized format designed specifically to improve the submission, review, and lifecycle management of regulatory information related to pharmaceuticals.
What is eCTD?
The eCTD is an electronic version of application, amendments, supplements and reports required by regulatory agencies like FDA, EMA and PMDA in relation to pharmaceutical products. It comprises a list of specifications of how content must be formatted, indexed and transmitted electronically.
Key aspects of eCTD include:
- XML Backbone: The XML file backbone is the table of contents and navigation scheme.
- Modular Format: The dossier is put in distinctly defined modules which correspond to the original CTD sections.
- Lifecycle Management: eCTD promotes continuous submission, which can then be updated and amended seamlessly without the need to resubmit the entire dossier.
- Interoperability: It makes it possible to exchange data with various regulatory bodies and organizations.
Structure of eCTD
The eCTD is structured into five modules, as in the original CTD format:
- Module 1 – Administrative Information and Prescribing Information: Region information such as application forms, labeling and regulatory correspondence.
- Module 2 – Common Technical Document Summaries: High-level summaries such as the Quality Overall Summary (QOS), Nonclinical Overview, and Clinical Overview.
- Module 3 – Quality: Chemistry, Manufacturing, and Controls (CMC) data.
- Module 4 – Nonclinical Study Reports: Pharmacology, toxicology, and pharmacokinetics data.
- Module 5 – Clinical Study Reports: Clinical trials, efficacy, and safety data.
The modules are subdivided into folders and files, which can easily be navigated through and reviewed based on the XML backbone.
Importance of eCTD in Pharmaceutical Industry
- Regulatory Compliance Regulatory submissions are mandatory in eCTD format in most major health authorities in the world, and as such, market approval is impossible without compliance.
- Efficiency and Speed eCTD submissions save paper and manual handling and increase the speed of review and approval.
- Enhanced Tracking and Lifecycle Management The ability to submit incremental updates simplifies dossier management over the product lifecycle.
- Higher Quality and Consistency. The standardized format reduces errors, omissions and inconsistencies in formatting.
- Global Harmonization eCTD allows submissions in multiple jurisdictions simultaneously making it quicker to launch a product in the global market.
Electronic Common Technical Document (eCTD) has been one of the major developments in the submission of pharmaceutical products that regulate compliance and efficiency across the world. Pharmaceutical companies can turn to Masuu Global to have access to professional solutions to eCTD which make the process of submissions easy and faster to get drug-approvals across different countries of the world.