The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

We’re back from the winter break, and this issue is packed with regulatory updates covering the period from mid-December to now.

Many of these changes replace older rules, update reporting timelines, or introduce new frameworks — so this one is worth bookmarking.

A big thank you to everyone who contributed by email or in Slack 🙏
This newsletter exists because you share what you see on the ground.

👇 Start with the 10-Second Summary below, then dive deeper into the details if something affects your work.

⏱️ 10-Second Summary (Read This First)

If you read nothing else in this issue:

• 🇺🇸 USA – New FDA safety reporting guidance makes the 2012 IND rules obsolete
• 🇳🇿 New Zealand – Fatal & life-threatening SUSARs now due in 15 days (not 7)
• 🇿🇦 South Africa – E2B R2/R3 accepted for clinical-trial SAE submissions
• 🇨🇳 China – Draft guideline proposes more standardised SUSAR reporting in trials
• 🇦🇪 UAE – Product & PV regulation moved from MOHAP to Emirates Drug Establishment (EDE)
• 🌐 ICH – E2B(R3) updated to align with revised E2D
• 🇩🇿 🇰🇼 🇱🇧 Algeria, Kuwait, Lebanon – New or final GVP frameworks published

Details and links below 👇

👀 This Period's Highlights

🇺🇸 USA — New Safety Reporting Guidance Makes the 2012 IND Rules Obsolete

On 15 Dec 2025, FDA published the final guidance:

“Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies.”

This guidance replaces the 2012 FDA IND safety reporting guidance.
If your SOPs, training materials, or inspection references still cite the 2012 document, they are now outdated.

What changed in practice

• Clearer expectations for aggregate safety assessment
• More flexibility regarding who performs aggregate review
• Clarifications on:
  • planned unblinding
  • scope and methodology of aggregate analyses
  • safety surveillance plan content

📌 Action​
This is now the reference document for US IND safety reporting.

👉 Updated on the USA RegIntelHub page​

🇳🇿 New Zealand — Clinical Trial Safety Reporting Rules Simplified

Medsafe published:

• Edition 3 of Clinical Trials – Regulatory Approval and GCP Requirements (Jan 2026)
• New guidance on Clinical Trial Safety Monitoring and Reporting​

⚠️ Key operational change

• Fatal and life-threatening SUSARs → 15 days (previously 7)

This brings CT safety reporting into a single, clearer framework, with the same submission approach now used for clinical-trial and post-marketing cases.

👉 All timelines and reporting rules updated on RegIntelHub​

🇿🇦 South Africa — E2B Accepted for Clinical Trial SAE Reporting

SAHPRA confirmed that E2B R2 or R3 XML formats may now be used for clinical-trial SAE submissions.

• Submissions via: ctcsaes@sahpra.org.za​
• Cover letter required (SAHPRA reference, protocol number, AE details, site and investigator information)
• CIOMS and SAHPRA forms remain acceptable

🔗 Official SAHPRA notice​

👉 Details reflected on the South Africa RegIntelHub page​

🇨🇳 China — Draft Guideline on Expedited Safety Reporting in Clinical Trials

On 4 Jan 2026, China’s NMPA/CDE opened a public consultation on a draft guideline covering expedited safety reporting during clinical trials.

The draft:

• Aligns with ICH E2A, E2B(R3), and M1
• Places stronger responsibility on sponsors
• Aims to improve consistency and data quality in SUSAR reporting

🔗 Consultation notice​
🔗 Draft guideline​

🇦🇪 UAE — Regulatory Authority Shift: MOHAP → Emirates Drug Establishment (EDE)

As of 29 Dec 2025, regulatory responsibility for medicines, medical devices, and pharmacovigilance has moved from MOHAP to the Emirates Drug Establishment (EDE).

👉 Full scope of the transition on the UAE RegIntelHub page​

🔗 Official announcement​

🌐 ICH — E2B(R3) Aligned with Updated E2D Guideline

On 15 Jan 2026, ICH published:

• an E2B(R3) Information Paper
• updated E2B(R3) Implementation Guide and code lists

This aligns E2B(R3) with the updated ICH E2D guideline (revised in Sept 2025) and clarifies key data elements, including:

• C.1.3 Type of Report
• C.5.4 Study Type Where Reaction/Event Was Observed

🔗 Official ICH documentation​

🇩🇿 🇰🇼 🇱🇧 Algeria, Kuwait & Lebanon — New GVP Frameworks Published

• 🇱🇧 Lebanon — Final LGVP modules published​
• 🇩🇿 Algeria — Final national Pharmacovigilance Good Practice Guide published
• 🇰🇼 Kuwait — K-GVP formally adopted by Ministerial Decree No. 385/2025​

🇪🇬 Egypt — Draft Guideline on Regulatory Oversight of Clinical Trials

On 16 Dec 2025, Egypt’s EDA published a draft Guideline for Good Regulatory Oversight of Clinical Trials for public consultation.

The draft aligns with ICH E6(R3) and EDA Chairman Decree No. 444/2025.

🔗 Announcement​
🔗 Draft guideline​

🇻🇳 Vietnam — New Circular on Clinical Trials (Effective Feb 2026)

Vietnam’s Ministry of Health issued Circular No. 50/2025/TT-BYT, signed 31 Dec 2025, effective 27 Feb 2026.

The circular sets requirements for GCP, trial conduct and registration, documentation, oversight, and approval of trial results, with five supporting appendices.

🇷🇺 Russia — Updated Pharmacovigilance Q&A Published

On 20 Jan 2026, Roszdravnadzor published updated FAQs covering ICSRs, PSURs, signals, PSMF, and risk-mitigation / emergency safety measures.

🔗 Official FAQs​

👉 Summary available on the Russia RegIntelHub page​

🌍 Other News in Brief

• ​ICH Glossary of Terms — Version 9 (9 Dec 2025)
• EU — EMA Industry Platform Highlights (Nov 2025)​
• EU — Political agreement on new pharmaceutical legislation​
• EU — Draft XEVMPD Web User Manual (Article 57)​
• EU — EURD list updated (17 Dec 2025)​
• Chile — MedDRA to be integrated into national AE reporting system​

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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.