The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

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This week brings major medical device developments and several important medicines updates.

👀 This Week’s Highlights

CIOMS publishes landmark report on Artificial Intelligence in Pharmacovigilance​

This is one of the most significant guidance documents to date on the implementation of AI across PV processes.

The report provides:

• A common vocabulary for AI in PV
• Guidance for regulators, MAHs, CROs, clinicians, academia, tech vendors, and patient groups
• Principles to support responsible development, evaluation, and deployment of AI-enabled PV solutions
• Considerations for governance, quality, validation, ethics, transparency, and oversight

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Belarus updates PSUR Submission Frequency List​

Belarus has issued Version 17 of the List of Medicinal Products Registered in Belarus, which defines PSUR submission frequency and timelines.

MAHs operating in Belarus should re-check their portfolio against the new list.

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India issues Digital Personal Data Protection Rules, 2025 — PV impact

India’s DPDP Rules introduce new requirements for handling safety data, including stricter security safeguards, breach-notification duties, minimum 1-year log retention, additional protections for pediatric/vulnerable-population data, and potential DPIA/audit obligations for large MAHs. PV teams should reassess SOPs, contracts, and data governance to ensure DPDP compliance.

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Other Updates in Brief

EMA: New “Compliance Notifications – Explanation & Q&A”​

EMA published guidance on automated monthly monitoring of ICSR compliance (7/15/90-day timelines) via EudraVigilance/EVDAS, with notifications sent to MAHs, sponsors, and NCAs.

Updated EMA IRIS Guide (v3.11)​

IRIS Guide updated with revised instructions for creating PIP modification applications (Section 13.3), clarifying steps and documentation for agreed PIP changes.

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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.
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