Compliance/PSMF System Description
GVP Module IPSMF

NoxReg — PSMF System Description

Reference: NXR-PSMF-SD-001Version: 1.0Date: April 2026

1. System Identification

System NameNoxReg Regulatory Intelligence Platform
VendorNoxReg (noxreg.com)
Contactsecurity@noxreg.com
Version1.0 (updated with each material change)
ClassificationGxP-adjacent computerised system (regulatory intelligence monitoring)

2. Intended Purpose

NoxReg is a regulatory intelligence SaaS platform designed to monitor 30+ global health authorities including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and other national competent authorities. The system automatically collects, classifies, and delivers regulatory publications to subscribed users.

Intended use in PV context: NoxReg supports pharmacovigilance signal management activities by monitoring health authority safety communications, guideline updates, and regulatory notices relevant to pharmacovigilance obligations. It is intended as an intelligence tool to assist qualified pharmacovigilance professionals — it does not replace human expert review or constitute a validated signal detection system.

3. Agencies Monitored

AgencyCountry / RegionUpdate Frequency
EMAEU / EEARSS: every 6h
FDAUSARSS: every 6h
MHRAUKHTML: daily
ANSMFranceHTML: daily
TGAAustraliaHTML: daily
Health CanadaCanadaRSS: every 6h
PMDAJapanHTML: daily
SwissmedicSwitzerlandHTML: daily
BfArMGermanyHTML: daily
AIFAItalyHTML: daily
INFARMEDPortugalHTML: daily
FAMHPBelgiumHTML: daily
ICHInternationalRSS: every 6h
HPRAIrelandHTML: daily
CBG-MEBNetherlandsHTML: daily
DKMADenmarkHTML: daily
MPASwedenHTML: daily
MedsafeNew ZealandHTML: daily
AGESAustriaHTML: daily
ANVISABrazilHTML: daily
COFEPRISMexicoHTML: daily
SAHPRASouth AfricaHTML: daily
HSASingaporeHTML: daily
CDSCOIndiaHTML: daily
NMPAChinaHTML: daily
MFDSSouth KoreaHTML: daily
Swissmedic (OTC)SwitzerlandHTML: daily
NZFSANew ZealandHTML: daily
EFPIAEuropeHTML: daily
WHOInternationalRSS: every 6h

4. Data Architecture

Application HostingVercel (global CDN)
DatabaseSupabase PostgreSQL, EU West region (Ireland) — all subscriber and regulatory data
AI ProcessingClaude (Anthropic) — regulatory document text only, no subscriber personal data
Email DeliveryResend
Regulatory update records5 years retention
Subscriber data2 years post-cancellation
AI generation logs5 years retention

5. AI Components

NoxReg uses Claude (Anthropic) large language model for:

  • Classification of regulatory updates into 7 categories (pharmacovigilance, safety, regulatory affairs, clinical, quality, labelling, general)
  • Importance scoring (urgent / important / informational)
  • Plain-English summarisation
  • Team action recommendations (Pro subscribers only)

All AI-generated content is labeled as such. AI outputs must be reviewed by a qualified regulatory professional before use in any regulated activity.

Prompt version: v1.2Model: Claude Haiku

6. Access Controls

AuthenticationSupabase Auth (email/password + OAuth)
AuthorisationRow-level security at database layer
Subscriber data isolationEach subscriber accesses only their own data
Employee accessNo employee access to subscriber data without auditable reason

7. Change Control

Material changes to NoxReg (AI model version, agency coverage, classification schema) are documented in a versioned changelog. Pro/Enterprise subscribers are notified of material changes via email with minimum 14 days advance notice where possible.

8. Backup & Recovery

BackupSupabase automated daily backups with point-in-time recovery
RTO4 hours
RPO24 hours

9. Limitations

  • NoxReg is not a validated signal detection system under GVP Module IX
  • AI classifications may contain errors — human review required
  • Coverage is best-effort; NoxReg does not guarantee capture of every publication from monitored agencies
  • Not a substitute for regulatory advice or qualified regulatory professional judgment
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