The electronic Common Technical Document (eCTD) is the globally recognized format for submitting regulatory applications to health authorities. Designed to streamline the regulatory review process, eCTD enables pharmaceutical companies to submit data in a structured, consistent, and electronic format. However, while the eCTD structure is harmonized under the International Council for Harmonization (ICH), implementation requirements vary across regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), and the United States Food and Drug Administration (US FDA).
Understanding these differences is crucial for maintaining regulatory compliance, avoiding rejections, and expediting the time-to-market. This article examines the distinct eCTD submission requirements for the MHRA, EMA, and FDA, highlighting key differences, operational challenges, and the advantages of expert support from trusted providers like eCTD Plus.
| Feature | MHRA | EMA | US FDA |
|---|---|---|---|
| eCTD Version | v3.2.2 | v3.2.2 | v3.2.2 (Transitioning to v4.0) |
| Module 1 Specification | UK-specific | EU-specific | US-specific |
| Submission Gateway | CESP / Email | CESP / eSubmission Gateway | ESG |
| Mandatory for Submissions | Yes (all major types) | Yes (centralised, MRP, DCP, national) | Yes (NDAs, ANDAs, BLAs, DMFs) |
| Life Cycle Management | Required | Required | Required |
While the core structure remains harmonized, regional modules, gateway protocols, and transition timelines result in operational complexity for global submissions.
Each agency demands unique administrative and legal documentation in Module 1. Incorrect metadata or omissions often lead to technical rejections.
Submission portals differ in file size limits, technical validation rules, and gateway credentials. Managing access and compliance across multiple platforms requires specialized knowledge.
Document life cycles, including version control and linking strategies, must comply with region-specific expectations, posing a challenge during variations and renewals.
As regulatory bodies transition to eCTD v4.0 at different paces, companies must maintain dual-system capabilities and ensure backwards compatibility.
Regulatory teams often lack the in-house expertise or tools required for compliant eCTD publishing, validation, and submission across all territories.
e-CTD Plus provides advanced eCTD publishing software solutions designed to meet the technical and regulatory demands of MHRA, EMA, and FDA submissions. With a focus on efficiency and compliance, e-CTD Plus offers a range of powerful features that simplify the submission process
Automatically ensures all file names and titles conform to regulatory standards.
Create CTD documents directly in Word or import existing Word files, and attach optimised PDFs.
Include relevant templates or guidelines directly at the leaf level for consistency.
Assign clear user roles such as Doer, Reviewer, and Publisher to streamline task management.
Access detailed reports and audit trails to track submission progress and activity.
Meet agency requirements with built-in hyperlinking and PDF compliance tools
Validate submissions using the latest MHRA, EMA, and FDA criteria.
Assists in ensuring submissions meet both technical and content expectations.
These features enable regulatory teams to produce high-quality, compliant eCTD submissions efficiently, reducing risk and accelerating approval timelines.
Although the eCTD standard is globally recognized, regional implementation differences across the MHRA, EMA, and US FDA create significant challenges for pharmaceutical companies. From module specifications to submission gateways, each authority imposes unique requirements that demand careful navigation. Leveraging professional support, such as the services offered by e-CTD Plus, enables organizations to achieve regulatory compliance, streamline global submissions, and stay ahead of evolving standards.