The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

This week is centred around ICH E2D(R1) — the long-awaited update on post-approval safety data management.

The revision clarifies how modern safety data sources (social media, patient support programs, market research, etc.) should be handled in pharmacovigilance systems.

It will soon start affecting operational PV processes in the EU.

As always, thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you 🙏

👇 Start with the 10-Second Summary, then dive deeper if something touches your portfolio.

⏱️ 10-Second Summary (Read This First)

If you read nothing else this week:

🇪🇺 EU — ICH E2D(R1) implementation begins 18 March 2026 (new guidance on solicited sources & post-approval safety data).
🇺🇸 US — FDA issues final guidance implementing ICH E2D(R1).
🇪🇺 EU — EURD list & PSUR submission frequencies updated.
🇩🇿 Algeria — CNPM reminds MAHs: ICSRs must be reported via national e-reporting system + “zero event” reporting required.

Details and links below 👇

👀 This Period's Highlights

🇪🇺 EU — ICH E2D(R1) Implementation Strategy Published

EMA has published the EU implementation strategy for ICH E2D(R1) on post-approval safety data.

The revision modernises the framework for managing safety information collected after marketing authorisation.

Key points

• Clarifies handling of solicited safety data sources (social media, patient support programs, market research, etc.)
• Updates terminology and standards for post-approval safety reporting
• Aligns safety surveillance expectations with current PV practice

Timeline

• 18 March 2026 — Guideline becomes effective in the EU
• Transition period until 18 September 2026 for MAHs to update processes

GVP Module VI will be revised to formally integrate E2D(R1).

Until then, the revised definitions and guidance should already be applied in line with the EMA implementation strategy.

What to review

PV teams should assess:

• handling of solicited programs and organised data collection​
• case identification and reporting rules
• SOP alignment with updated definitions

This is a structural update to post-marketing safety data management.

🇺🇸 United States — FDA Final Guidance on ICH E2D(R1)​

The FDA has issued final guidance implementing ICH E2D(R1).

The document replaces the original 2003 E2D guidance and aligns US expectations with the updated ICH framework.

The guidance clarifies:

• treatment of modern safety data sources
• terminology used in post-approval safety reporting
• expectations for expedited reporting of ICSRs

This further strengthens global alignment on post-marketing safety surveillance.

🇩🇿 Algeria — Reminder on ICSR and “Zero Event” Reporting​

The Algerian National Centre for Pharmacovigilance and Materiovigilance (CNPM) issued a regulatory reminder on PV reporting obligations.

Key points:

• ICSRs must be reported exclusively via the national e-reporting platform​
• reporting must follow national PV timelines and technical requirements
• companies must ensure access to the CNPM system

Zero-event reporting

If no ICSRs are reported for a 3-month period, MAHs must submit a case-free (“zero event”) report to CNPM.

The notice aims to reinforce compliance with national pharmacovigilance reporting obligations.

🇪🇺 EU — EURD List & PSUR Frequencies Updated

EMA has published an updated EURD list and PSUR submission frequency file.

MAHs should verify whether any products in their portfolio have:

• updated EU reference dates (EURD)​
• modified PSUR submission timelines

Routine update — but important for compliance planning.

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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.