The RegIntelHub Weekly

Global PV updates, distilled.

👀 This Week’s Highlights

This week’s updates focus on documentation, submissions, and system updates - from CTIS changes in the EU to new PSMF requirements in South Africa.

🇪🇺 EU — CTIS Sponsor Handbook Updated (v6.1)

After nearly 18 months, EMA has released an updated version (6.1) of the Clinical Trial Information System (CTIS) Sponsor Handbook (dated 7 Nov 2025).
Key updates include:

• Clarifications on Multi-Factor Authentication and OMS change requests
• Broader permissions for sponsor users to modify documents within NSM
• Editorial updates to sections 4.3.1 and 4.8 for clarity

📘 Action: review and align your CTIS procedures — access the new version here: EMA Sponsor Handbook v6.1 (PDF)​
👉 Check all EU-level PV and CT updates on the European Union page of RegIntelHub​

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🇵🇹 Portugal — PV Contact Updates Now via SMUH-ALTER

INFARMED issued Circular No. 125/CD/550.20.001, requiring all MAHs to update their national PV contact details exclusively via the SMUH-ALTER portal by 31 Jan 2026.
Exceptions apply only to:

• New MA applications (details already in dossier)
• Centralised procedures (submit updates by email to centralizados@infarmed.pt)

📌 Don’t miss this — it’s an administrative change with compliance implications.

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🇿🇦 South Africa — SAHPRA Requests Updated PSMFs

SAHPRA issued Communication PV032025/26, requesting all MAHs/Applicants to submit their latest Pharmacovigilance System Master File (PSMF) by 12 Nov 2025.
The PSMF must:

• Indicate total PV staff count
• Include a list of all registered and marketed products

Submissions go to GVP@sahpra.org.za, subject line: “PSMF & Product/PV Resourcing – [Company Name]”.
👉 See submission details on the South Africa page of RegIntelHub​

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🌍 Other Updates in Brief

Here’s what else moved this week across the regulatory landscape:

• 🇨🇷 Costa Rica – New Circular MS-DRPIS-2790-2025 renames the competent authority to the Directorate for Regulation of Products of Sanitary Interest and Risk (DRPIRS). Effective 28 Oct 2025.
• 🇯🇴 Jordan – JFDA launches public consultation (6 Nov–7 Dec 2025) on two user guides:
  • Guidance for Healthcare Providers on ADR Reporting v2.0​
  • User Guide for Electronic Reporting for Pharma Companies v1.0​
• 🇪🇺 EU (CMDh) – Updated Q&A on Pharmacovigilance Legislation (Revision 26) to align with new EC variation categories, effective 15 Jan 2026.

🗣️ Join the Conversation

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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.