Introduction
In pharmacovigilance, Local Safety Databases (LSDs) are critical for ensuring continuous monitoring of drug safety within specific countries or regions. While the WHO’s VigiBase serves as a global repository of adverse event data, local databases enable targeted risk assessment, regulatory compliance, and region-specific signal detection.
Each national authority manages its own system to collect and evaluate Individual Case Safety Reports (ICSRs) ensuring that adverse reactions, serious events, and unexpected findings are captured and acted upon in accordance with regional Good Pharmacovigilance Practices (GVP).
Understanding Local Safety Databases
A local safety database is a regulatory system designed to capture, evaluate, and store information about adverse drug reactions (ADRs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) occurring within a specific country.
Core Functions
- Collection and management of Individual Case Safety Reports (ICSRs)
- Assessment of serious and non-serious adverse events
- Facilitation of signal detection and risk–benefit evaluation
- Support for regulatory decision-making and public health protection
These national databases ensure timely and compliant reporting, bridge data with VigiBase, and provide insight into local demographic and prescribing trends.
Global Safety Database (VigiBase) vs Local Safety Databases
|
Feature |
VigiBase (Global WHO Database) |
Local Safety / National Database |
|
Managing Entity |
Uppsala Monitoring Centre (UMC) on behalf of the World Health Organization (WHO) within the WHO Programme for International Drug Monitoring (PIDM). |
Managed by national competent authority (e.g., EMA, FDA, SFDA, EDA) or Marketing Authorization Holder (MAH) within a specific country or region. |
|
Data Source |
Aggregates Individual Case Safety Reports (ICSRs) submitted by 180+ national pharmacovigilance centres worldwide (WHO PIDM members). Each country forwards its validated reports to UMC. |
Collects local ADRs and AEFIs directly from healthcare professionals, patients, or MAHs, limited to the specific national or regional population. |
|
Data Volume & Scope |
Contains >40 million ICSRs (as of 2025) covering all drug classes and vaccines globally. Enables global signal detection and cross-country comparisons. |
Smaller datasets focused on local cases, demographics, and prescribing patterns — allows detection of region-specific trends and supports national decision-making. |
|
Purpose / Core Use |
• Global signal detection using advanced algorithms (e.g., vigiRank, disproportionality analysis). |
• Regulatory compliance: mandatory collection and evaluation of local ICSRs. |
|
Data Confidentiality & Completeness |
• ICSRs are anonymized; personal identifiers and full narratives are restricted. |
• Local databases often store more granular data (lab results, scans, narratives). |
|
Output Examples |
• VigiAccess (for qualified users and public summaries). |
• Local PV bulletins or alerts (e.g., EMA ADR reports, SFDA Safety Communications, FDA MedWatch summaries). |
|
Typical Users |
WHO, UMC analysts, national PV centers, selected regulators, academic researchers (under agreement). |
Local competent authorities, MAHs, local QPPVs, healthcare institutions. |
Regional Overview of Local Safety Databases
Europe
- Database: EudraVigilance
- Managing Authority: European Medicines Agency (EMA)
- Timelines:
- Serious cases: 15 days
- Non-serious cases: 90 days
United States
- Database: FDA Adverse Event Reporting System (FAERS)
- Managing Authority: U.S. Food and Drug Administration (FDA)
- Timelines:
- Serious and unexpected adverse events: 15 calendar days
- Non-serious: Quarterly/Annually, based on commitments
Canada
- Database: Canada Vigilance
- Managing Authority: Health Canada
- Timelines:
- Serious (expected or unexpected): 15 days
- Non-serious: Not submitted individually; maintained for aggregate reporting
Australia
- Database: Database of Adverse Event Notifications (DAEN)
- Managing Authority: Therapeutic Goods Administration (TGA)
- Timelines:
- Serious cases: 15 days
- Non-serious: Maintained internally for signal detection
New Zealand
- Database: Centre for Adverse Reactions Monitoring (CARM)
- Managing Authority: Medsafe
- Timelines:
- Serious cases: 15 days
- Non-serious: Maintained internally
Middle East & North Africa (MENA)
Kingdom of Saudi Arabia (KSA)
- Database: National PV Centre (NPC)
- Managing Authority: Saudi Food & Drug Authority (SFDA)
- Timelines:
- Serious: 15 days
- Non-serious: 90 days
United Arab Emirates (UAE)
- Database: National PV System (MOHAP / DOH)
- Timelines:
- Serious: 15 days
- Non-serious: 90 days
Egypt
- Database: Egyptian Pharmacovigilance Centre (EPVC)
- Timelines:
- Serious: 15 days
- Non-serious: 90 days
Tunisia
- Database: Centre National de Pharmacovigilance (CNPV)
- Timelines:
- Serious: 15 days
- Non-serious: 90 days
Asia-Pacific
China
- Database: National Center for ADR Monitoring (NCADRM)
- Managing Authority: National Medical Products Administration (NMPA)
- Timelines:
- Serious ADRs: 15 days
- Non-serious ADRs: 30 days
- Group SADRs: Immediate
- Foreign SADRs: 15 days
India
- Database: CDSCO Pharmacovigilance Programme of India (PvPI)
- Managing Authority: Central Drugs Standard Control Organization (CDSCO)
- Timelines:
- Serious: 15 days
- Non-serious: 30–90 days (depending on reporting channel and CDSCO guidance version)
Eurasia
Russia
- Database: Roszdravnadzor Automated Information System (AIS)
- Managing Authority: Roszdravnadzor
- Timelines:
- Fatal/life-threatening serious ADRs: 72 hours
- Other serious ADRs: 15 days
Latin America
Brazil
- Database: VigiMed (ANVISA Portal)
- Managing Authority: ANVISA
- Timelines:
- Serious ADRs: 15 days
- Non-serious: Periodic (included in aggregate reports)
- Device-related events: 72 hours (for deaths or major threats)
Mexico
- Database: COFEPRIS PV System / Vigiflow
- Managing Authority: COFEPRIS
- Timelines:
- Fatal serious ADRs: 7 days
- Non-fatal serious ADRs: 15 days
- Non-serious ADRs: 90 days
Chile
- Database: ISP PV System
- Managing Authority: Instituto de Salud Pública (ISP)
- Timelines:
- Fatal serious ADRs: 7 days
- Non-fatal serious ADRs: 15 days
- Non-serious ADRs: 90 days
Argentina
- Database: ANMAT PV System (eReporting Portal)
- Managing Authority: ANMAT
- Timelines:
- Fatal serious ADRs: 7 days
- Non-fatal serious ADRs: 15 days
- Non-serious ADRs: 90 days
Colombia
- Database: INVIMA eReporting System (SiVICOS)
- Managing Authority: INVIMA
- Timelines:
- Serious ICSRs: 15 days
- Non-serious ICSRs: 90 days
Key Takeaways
- Local Safety Databases ensure national regulatory compliance and provide real-time insights into region-specific safety trends.
- The 15-day rule for serious cases is a near-universal standard, while non-serious cases are typically reported within 30–90 days or maintained for periodic analysis.
- Integration between local and global systems (like VigiBase) supports harmonized signal detection and rapid global response to emerging safety issues.
- Continuous updates to local timelines (e.g., Brazil, Russia, India, China) highlight the importance of staying aligned with current national pharmacovigilance guidance.
Authored By : Lamees El-Heeny
Head of Pharmacovigilance, Baupharma.
