The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

This week leans technical.

Electronic reporting, DSUR expectations, RMP obligations, terminology standards, and MedDRA updates.

If you work in operations, safety systems, or global oversight — read carefully.

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:

🇨🇭 ICH — Final E2B(R3) training module published (ICSR electronic transmission).
🇨🇳 China — CDE issues DSUR Q&A aligned with ICH E2F.
🇴🇲 Oman — Updated Local Safety Responsible (LSR) details required by 12 Mar 2026.
🇵🇰 Pakistan — RMP submission mandatory for new drugs + active surveillance obligations expanded.
🌍 IMDRF — New guidance on selecting medical device AE terminologies.
🌍 MedDRA — Version 29.0 released (complex change version).

Details and links below 👇

👀 This Period's Highlights

🇨🇳 China — DSUR Q&A Published (ICH E2F-Aligned)

CDE (NMPA) issued a Q&A document on Development Safety Update Reports (DSURs) during clinical trials.

The document clarifies preparation and submission expectations under:
• ICH E2F
• China regional requirements

Why it matters

China is refining DSUR expectations — this often reflects common sponsor deficiencies.

Action

If China is in scope:
• Review DSUR templates
• Align submission timelines and structure
• Share with clinical safety teams

🇴🇲 Oman — Updated LSR Information Required (Deadline 12 March 2026)

Oman MOH Drug Safety Center issued Circular No. 20/2026.

All MAHs must submit updated details for their Local Safety Responsible (LSR), including contact information.

Deadline: 12 March 2026

Action

• Confirm LSR details are current
• Submit via designated link before deadline
• Ensure internal PV contact lists are aligned

Operational housekeeping — but deadline-driven.

🇵🇰 Pakistan — RMP Mandatory + Active Surveillance Expanded​

DRAP now requires:

• RMP submission with all new drug applications​
(including biologics & vaccines; reference authority–approved)

• RMP copy to NPC post-registration

• Active surveillance for:​
– New vaccines/biologics (incl. mAbs)
– New active substances
– HIV, TB, malaria, hepatitis treatments
– Orphan drugs
– Products approved under exceptional/EUA conditions

• Newly identified risks → updated RMP submission to NPC

Impact: Formalised RMP + post-marketing surveillance expectations.

Do this:​
• Include RMP in Pakistan dossiers
• Check if active surveillance applies to your products
• Align NPC reporting workflows

🇨🇭 ICH — Final E2B(R3) Training Module Published

ICH has released Module III of the Implementation Guide for Electronic Transmission of ICSRs under E2B(R3).

This completes the planned E2B(R3) training series.

What this means

• Technical clarification of electronic ICSR submission standards
• Reinforces harmonised electronic exchange expectations
• Useful reference for system validation, upgrades, and audit prep

Action

If you manage safety systems or E2B gateways:
• Share with IT / safety database teams
• Keep as reference for inspection defense

Not a regulatory change — but a useful harmonised technical resource.

🌍 IMDRF — Guidance on Medical Device AE Terminology Selection​

IMDRF published guidance on selecting adverse event terminologies for medical device vigilance.

Focus areas:

• Criteria for terminology selection
• Alignment with SNOMED CT, ICD, MedDRA
• Emphasis on scope, granularity, regulatory compatibility
• Supports global harmonisation

Impact: No new obligation — but signals increasing terminology standardisation across markets.

Relevant for global device manufacturers and vigilance leads.

🌍 MedDRA Version 29.0 Released (1 March 2026)

MedDRA v29.0 is a complex change release.

Key points:

• 1,380 change requests processed (1,042 approved)
• No new SOCs or HLGTs
• 1 new HLT added, 1 merged
• 255 PT changes affecting existing SMQs
• No new SMQs

Impact: Potential hierarchy-level effects on queries and signal detection.

Do this:​
• Plan dictionary upgrade validation
• Review SMQ and PT impacts
• Reconfirm signal queries post-migration

🗣️ Join the Conversation & Contribute

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Until next week - stay compliant, stay curious.

⚖️ 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.