Global PV updates, distilled - powered by our community
This week’s updates are a good reminder that regulatory change isn’t always loud — sometimes it’s subtle alignment shifts, scope clarifications, or “nothing new, but now written down”.
Several of these updates won’t require immediate SOP rewrites, but they absolutely affect how you justify your current setup during audits, inspections, and internal reviews.
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:
🇬🇧 UK — PV requirements for Category 1 and Category 2 products formally diverge from Feb 2026 (with a pragmatic mitigation approach)
🇲🇾 Malaysia — GCP 5th Edition (ICH E6(R3)-aligned) becomes mandatory upon publication in March 2026
🌍 CIOMS — Cumulative Pharmacovigilance Glossary updated to Version 2.4
🇪🇺 EU — GVP guideline on pregnancy & breastfeeding updated (tracked changes published)
🇪🇺 EU — New EV training module on international transfer of personal health data
🇰🇷 South Korea — RMP guideline updated (Dec 2025)
🇨🇭 Switzerland / EU / Malaysia — Several “quiet but important” document updates released
Details and links below 👇
👀 This Period's Highlights
🇬🇧 United Kingdom — PV Requirements for Category 1 vs Category 2 Products Will No Longer Be Aligned
The UK has published updates to CIR 520/2012, confirming a key structural change effective 12 February 2026.
What’s happening
From that date:
- Category 2 products will be subject to the amended CIR 520/2012
- Category 1 products will remain subject to HMR Schedule 12A
- The two legal texts will no longer be fully aligned for pharmacovigilance requirements
The important (and helpful) mitigation
To avoid unnecessary operational burden, the UK is taking a pragmatic approach:
- If you hold both Category 1 and Category 2 products in the UK →
👉 You may follow the amended CIR 520/2012 for all products
- If you hold Category 1 products only →
👉 Continue following Schedule 12A, unless those products also have EU licences — in which case the amended CIR should be followed
Why this matters
- This is less about changing how you do PV day-to-day
- And more about which legal basis you cite in SOPs, PSMFs, and inspection responses
- UK-only portfolios vs UK+EU portfolios will need slightly different justifications
🇲🇾 Malaysia — GCP 5th Edition Becomes Mandatory (ICH E6(R3)-Aligned)
Malaysia’s NPRA has issued Directive No. 7 of 2026 under Regulation 29 of the Drug and Cosmetics Control Regulations 1984 ⚖️.
What’s confirmed
-
The Malaysian Guideline for Good Clinical Practice (GCP) – 5th Edition will be:
- Launched in March 2026
- Mandatory immediately upon publication
- The 5th Edition aligns with ICH GCP E6(R3)
Why this matters
-
Sponsors running trials in Malaysia should:
- Track publication closely
- Be ready to justify E6(R3) alignment from day one
-
Expect knock-on effects for:
- Safety oversight
- Documentation
- Sponsor responsibilities
🌍 CIOMS — Cumulative Pharmacovigilance Glossary Updated (Version 2.4)
CIOMS has published Version 2.4 of its Cumulative Pharmacovigilance Glossary.
What this is
- A consolidated, structured glossary of PV terms used across 18 CIOMS Working Group reports (1992–2025)
- Includes references back to original CIOMS publications and source definitions
Why this matters
-
This is a quiet but valuable reference for:
- SOP wording
- Training materials
- Consistent terminology across teams
- Especially useful when aligning global documentation language
🇪🇺 EU — GVP Guideline Updated for Pregnancy & Breastfeeding (Tracked Changes)
EMA has published a tracked-changes version of:
GVP Product- or Population-Specific Considerations III:
Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
(06 Feb 2026)
Why this is important
This update strengthens expectations for how MAHs monitor, assess, and report safety data in these populations across the full product lifecycle.
The guidance now provides clearer structure for:
- ICSR handling & event selection
– including pregnancy exposure and outcome coding
- Pregnancy follow-up questionnaires
– and when product-specific tools are needed
- PSURs
– structured pregnancy outcome tabulation and exposure analysis
- Signal management
– methodological challenges and case retrieval approaches
- RMPs and PASS planning
Bottom line
This becomes a core reference document for maternal and child health safety surveillance — not optional reading.
🇪🇺 EU — EV-M8 Training Module on International Data Transfers
EMA has published Training Module EV-M8 on the international transfer of personal (health) data in ICSRs and SUSARs originating in the EU (02 Feb 2026).
Is this new?
Not really.
Is it useful?
Very.
Why it’s worth your time
- Pulls GDPR, PV, and EV expectations into one coherent explanation
- Walks through common real-world scenarios that tend to cause compliance anxiety
- Reassures you when your current setup is defensible — and when it isn’t
📌 Highly recommended as a self-check for EU data-transfer compliance.
🌍 Other Updates in Brief
Here’s what else moved this period:
🇰🇷 South Korea — Guidelines for Risk Management Plans for Pharmaceuticals updated (23 Dec 2025)
🇲🇾 Malaysia — Serious Breach Reporting FAQs (2025) published
🇪🇺 EU — EMA Data Protection Notice for EudraVigilance Human (EV) updated (05 Feb 2026)
🇪🇺 EU — EURD list & PSUR frequency file updated (04 Feb 2026)
🇨🇭 Switzerland — Swissmedic Journal, January 2026 edition published (04 Feb 2026)
🗣️ 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.
