The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

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👉 Send it to info@regintelhub.com or DM/tag us on LinkedIn.

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👀 This Week’s Highlights

🇸🇻 El Salvador - New User Guide for Clinical Trial Submissions (SRS–CNEIS-ES)

El Salvador’s Superintendency of Health Regulation (SRS) published the first User Guide for the SRS–CNEIS-ES digital platform (17 Nov 2025). The guide finally provides clear instructions for:

• Submitting Phase I, II, and III clinical trial applications
• Pilot/pivotal study submissions
• Post-authorization updates
• Clinical trial adverse event reporting

Why it matters:​
Sponsors, investigators, and legal reps now have a clear, structured guide to avoid submission errors and accelerate processing in the national CT system.

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🇪🇺 EU - EURD List Updated (Revision 154, 19 Nov 2025)

The List of European Union Reference Dates (EURD) and PSUR submission frequencies has been updated to Revision 154.

What this means:​
Your PSUR timeline or frequency may have changed.
​Action: Re-check your PSUR planning calendar and adjust internal tracking tools.

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🇪🇹 Ethiopia - Mandatory Registration in EFDA-MVC Traceability Hub​

EFDA now requires all Marketing Authorization Holders (MAHs) and manufacturers to complete registration in the EFDA-MVC Traceability Hub within 15 working days.

Deadline: 2 December 2025

Why it matters:​
This is a mandatory national traceability compliance step, with direct implications for serialization, supply-chain visibility, and regulatory oversight.

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Until next week - stay compliant, stay curious.

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⚖️ Disclaimer
This newsletter is for informational purposes only and does not constitute professional or legal advice.
All summaries are based on publicly available regulatory information. Always verify requirements with the relevant authority or qualified professional before implementation.
RegIntelHub assumes no liability for actions taken based on this content.