The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

A lighter week — mostly clarifications and alignment updates.

Nothing dramatic. But each item affects how you justify your setup during inspections.

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:

🇨🇦 Canada — CV database screening no longer required for ICSR compliance.
🇵🇾 Paraguay — CT requirements aligned with ICH E6(R3); CSR submission now mandatory within 12 months.
🇬🇧 UK — MHRA clarifies transitional CT timelines and labelling expectations.

Details and links below 👇

👀 This Period's Highlights

🇨🇦 Canada — Section 4.3 updated: CV database screening no longer required

Health Canada has issued a clarification to Section 4.3 of its guidance on reporting adverse reactions to marketed health products.

What changed:

MAHs are not required to:

• Screen the Canada Vigilance Online Database
• Monitor Health Product InfoWatch

to meet their ICSR reporting obligations.

At the same time:

• Reporting of serious unexpected foreign cases remains mandatory.
• New clarification helps determine when a product can be excluded because it is clearly not yours (product identification criteria).

What this means for you:

• Remove routine CV database monitoring from compliance checks
• Update SOP language on foreign authority case assessment
• Train teams on the new product identification exclusion criteria

🇵🇾 Paraguay — CT requirements aligned with ICH E6(R3) (Resolution 056/2026)

DINAVISA has expanded Resolution 238/2024 through Resolution 056/2026, strengthening alignment with ICH standards.

What changed:

1️⃣ Investigator’s Brochure must comply with ICH E6(R3)​
Including all applicable supporting documentation.
Non-compliance may lead to rejection.

2️⃣ Global Clinical Study Reports (CSR) must be submitted​
Within 12 months of study completion, aligned with ICH E3.
This is in addition to previously required final reports.

What to do now:

• Review IB templates for E6(R3) alignment
• Add CSR submission timelines to trial close-out checklists
• Inform global teams about the 12-month CSR requirement
• Update country trackers

🇬🇧 United Kingdom — MHRA clarifies clinical trial transitional arrangements

MHRA updated guidance under the clinical trial regulations.

What was clarified

• Timelines for notifying intent to continue under old PV rules
• Substantial labelling updates require MHRA approval
• Post-QP certification labelling expectations from 28 April 2026

What to do now

• Reconfirm whether your trials follow old or new PV rules
• Ensure TMF documentation clearly reflects your chosen pathway

🗣️ Join the Conversation & Contribute

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Hit reply to share your thoughts or tell us if we missed an update.

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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.