The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

Hi,

Quick catch-up on what moved this week — and, more importantly, what it means for you in practice.

As always, thank you to everyone who shared links, documents, and local insights by email or in Slack . This newsletter exists because you surface what’s changing before it becomes a surprise.

👇 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 this week:

• 🇧🇷 Brazil — Anvisa published a Q&A on RDC 945/2024 / IN 338/2024.
  ​Use it as a checklist for DDCM, DEEC, and substantial amendments — it reflects real reviewer pain points.
• 🇨🇭 Switzerland — Swissmedic rewrote its signal reporting guidance (effective 1 Feb 2026).
  ​Signal timelines, Day 0 definitions, PI update workflows, and authority-driven signals all changed.
• 🇹🇷 Turkey — New clinical practice guideline for regenerative & advanced therapies.
  ​Explicit PV obligations now apply — “non-trial use” does not mean “no PV.”
• 🇪🇨 Ecuador — Updated instructions for SAE/SUSAR reporting and safety follow-up in clinical trials.
  ​Check timelines and formats if Ecuador is in scope.
• 🇪🇺 EU — EMA updates on signal detection post-EV pilot, ESI contact points, EV/EV-SSA data protection, and EVVet3 system changes.
  ​Mostly operational — but relevant for inspections and audits.

Details and links below 👇

👀 This Period's Highlights

🇧🇷 Brazil — Anvisa Q&A on RDC 945/2024 & IN 338/2024 (Clinical Trials)

What’s new​
Anvisa has published an official Questions & Answers document clarifying how RDC 945/2024 and IN 338/2024 should be applied in real submissions.

This isn’t a new regulation — it’s Anvisa explaining where sponsors keep getting stuck.

Why this matters​
The Q&A is built directly from:

• recurring deficiencies in DDCM and DEEC submissions
• frequent issues with substantial amendments and investigational product changes

In other words: this is Anvisa telling you why your last submission may have been delayed.

What to do now

• Use this Q&A as a pre-submission checklist, especially for:
  • DDCM scope and structure
  • DEEC content
  • substantial protocol amendments
  • substantial IMP modifications
• Don’t treat it as “nice to read” — this is effectively a window into Anvisa reviewers’ expectations.
• Remember: it’s non-binding, but ignoring it increases the risk of technical questions.

🇨🇭 Switzerland — Swissmedic overhauls signal reporting guidance (effective 1 Feb 2026)

What’s new​
Swissmedic has fully revised:

• the Guidance document: Drug Safety Signals HMP (now version 10)
• the Signal Notification Form (new layout, aligned to the guidance)

This is not cosmetic — timelines, obligations, and workflows changed.

Key changes you should know

• Clearer start/end of signal reporting obligations
• Signals from authorities
  • No reporting obligation for MAHs of KAS without innovation, biosimilars, and co-marketing products if PI is updated by conformation
  • Signals without serious risk: reporting deadline extended from 30 → 90 days
  • Day 0 redefined for EMA PSUR/PSUSA outcomes
• Product information updates
  • No longer submitted in parallel with signal reports
  • Risk minimisation now handled fully inside the signal evaluation procedure
• New signal evaluation procedure
  • If Swissmedic agrees with “no action needed,” silence after 6 months = consent
• KAS with innovation
  • Conformation is not allowed — MAHs must actively implement PI changes
• New publication stream
  • “Safety Update – Information for healthcare professionals”

What to do now

• Update Swiss local signal SOPs — this version changes assumptions many teams rely on
• Re-train anyone handling:
  • authority-driven signals
  • PSUR/PSUSA outcomes
  • PI update workflows
• Replace the old Signal Notification Form before February 2026

🇹🇷 Turkey — New Clinical Practice Guideline for Advanced & Regenerative Therapies​

What’s new​
TITCK has published a Clinical Practice Guideline for regenerative medicine and advanced therapeutic medicinal products, in force since 23 January 2026.

This sits outside classical clinical trials — closer to hospital exemption-type use.

Why this matters

• The guideline introduces explicit pharmacovigilance obligations
• Adverse reactions from these clinical applications must be reported
• Ongoing safety follow-up and periodic reporting are expected

What to do now

• If you support ATMPs or regenerative therapies in Turkey:
  • review Article 14 and Annex 3 (PV / biovigilance section)
  • check whether your current PV system captures these cases
• Don’t assume “non-trial use” = “no PV”

🇪🇺 EU — Signal detection, EV data protection & system updates

A few smaller but relevant updates you may want on your radar:

• ​EMA Q&A on Implementing Regulation (EU) 2025/1466​
  Clarifies MAH responsibilities following the end of the EudraVigilance signal detection pilot.
• ​Updated ESI contact points​
  Useful if you’re escalating emerging safety issues at NCA level.
• EMA data protection notices
  • ​EudraVigilance Human (EV)​
  • ​EV Signal & Safety Analytics (EV-SSA)​
• ​EVVet3 / EVWeb production release notes​
  For anyone touching veterinary EV environments.

🇪🇨 Ecuador — Updated clinical-trial safety reporting instructions

Two newly issued (but easy to miss) documents from ARCSA:

• ​External Instruction v3.0​
  Serious adverse events (EAG) and SUSAR (RAGI) reporting in clinical trials
• ​External Instruction v1.0​
  Submission and review of clinical-trial safety follow-up reports

What to do now

• If Ecuador is in scope for your trials:
  • update timelines and report formats
  • check alignment with global DSUR / SUSAR processes

🗣️ 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.