Global eCTD Submission Portals: A Regional Reference for Regulatory Professionals

Global eCTD Submission Portals: A Regional Reference for Regulatory Professionals

The Electronic Common Technical Document (eCTD) has established itself as the worldwide standard for regulatory submissions. While the core structure remains consistent, the delivery mechanisms—the submission portals—vary significantly by country. Navigating these portals correctly is essential for maintaining compliance and ensuring the review clock starts on time.

---

Major Submission Portals by Region

Regulatory professionals must manage a diverse array of platforms, each with its own authentication protocols (such as digital certificates or government-issued tokens).

Americas

• United States (FDA): ESG – Electronic Submissions Gateway
• Canada (Health Canada): CESG – Common Electronic Submissions Gateway
• Brazil (ANVISA): Datavisa

Europe

• European Union (EMA): eSubmission Gateway / Web Client / CESP (Common European Submission Platform)
• United Kingdom (MHRA): MHRA Submissions Portal

Asia-Pacific

• Japan (PMDA): eCTD Portal
• China (NMPA): CDE eCTD Portal
• Singapore (HSA): PRISM
• Australia (TGA): eSubmission Portal
• Malaysia (NPRA): QUEST3+
• India (CDSCO): SUGAM

Middle East & Africa

• GCC (Gulf Cooperation Council): Centralized Submission System

---

Critical Success Factors for Global Submissions

Successful eCTD submission involves more than just uploading a file. Regulatory teams must pay close attention to the following:

1. Module 1 Specifications: While Modules 2 through 5 are largely harmonized via ICH, Module 1 is region-specific. It contains administrative information and prescribing information tailored to local laws.
2. Authentication Methods: Portals utilize various security layers, including high-level digital certificates, physical USB tokens, or specific government login systems.
3. Gateway Testing: Many agencies, such as the FDA, require a successful gateway test submission before a company is authorized to send live regulatory applications.

Conclusion

Understanding the landscape of global submission portals is a cornerstone of effective regulatory operations. By staying updated on portal transitions and regional technical requirements, companies can avoid administrative rejections and expedite the delivery of innovative medicines to patients worldwide.