The RegIntelHub Weekly

Global PV updates, distilled - powered by our community

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:

Details and links below 👇

👀 This Period's Highlights

🇺🇸 United States — FDA launches AEMS, a unified adverse event platform

The FDA has launched a new platform called the Adverse Event Monitoring System (AEMS), intended to serve as the single access point for adverse event data across all product categories the agency regulates. The move ends the era of product-specific databases that PV professionals have worked with for decades.

• Already live in AEMS: FAERS (drugs, biologics, cosmetics), VAERS (vaccines, co-managed with CDC), AERS (animal drugs and foods)
• Moving to AEMS by May 2026: MAUDE (medical devices), HFCS (human foods and dietary supplements), CTPAE (tobacco products and ENDS)
• By May 2026, AEMS will carry real-time adverse event reports for all FDA-regulated products, subject to patient confidentiality obligations

What to do:

• Bring this to your safety systems and signal detection teams — the MAUDE cutover in May is the critical date to plan around
• Audit SOP and training material references to FAERS and MAUDE — both will need updating
• If your team uses any automated data feeds or queries against legacy databases, begin scoping the migration now
• Run parallel checks during the transition to confirm AEMS outputs match what you were seeing in the legacy systems

🇲🇽 Mexico — CNFV becomes CENAFyT, consolidating PV and technovigilance

Mexico has formally expanded the remit of its national pharmacovigilance body. The existing National Pharmacovigilance Centre has been replaced by the National Centre for Pharmacovigilance and Technovigilance — CENAFyT — which now oversees both medicines and medical devices under a single structure. This is not an administrative reshuffle; it follows a statutory amendment to the General Health Law that came into force in January 2026.

• CENAFyT assumes responsibility for both pharmacovigilance and technovigilance reporting and coordination nationally
• The two key technical standards — NOM-220 on PV and NOM-240 on technovigilance — are both scheduled for revision
• All stakeholders within Mexico's national PV system are expected to update their reporting processes to reflect the new structure

What to do:

• Update Mexico PV contact lists and submission addresses to reflect CENAFyT
• Monitor for revised NOM standards — both are priority updates under the new centre
• If your portfolio includes medical devices in Mexico, technovigilance obligations now fall under the same body as PV

🇪🇬 Egypt — updated PSUR Supplementary List now in effect

The Egyptian Drug Authority has issued a revised PSUR Supplementary List, which took effect on 12 March 2026. The list sets out the active substances for which periodic safety reports are required in Egypt, along with the applicable submission frequencies and reference dates.

What to do:

• Review the updated list against your Egypt portfolio — substances and timelines may have changed
• Adjust any upcoming PSUR due dates in your submission tracker if needed

Also this week:

🇹🇷 Turkey — TITCK issued a first revision to its clinical trial FAQ on 10 March 2026. The document covers practical conduct requirements for trials operating in Turkey. If Turkey is in scope, share with local trial teams and check for anything that affects your current setup. Source​

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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.