Global Data Sources

Overview

VIGIA provides direct API access to multiple global regulatory data sources, enabling on-demand queries without scraping delays. These endpoints supplement scheduled surveillance by providing real-time access to regulatory databases.

Available Sources

FDA

US FDA medical device recalls and safety alerts

EMA

European Medicines Agency safety updates

DIGEMID

Peru regulatory authority alerts and product registry

VigiAccess

WHO global adverse drug reaction database

Regulators API

Query multiple regulatory agencies for product information. Base Path: /api/v1/regulators Implementation: backend/app/routers/regulators.py

Search All Agencies

Search across all configured regulatory agencies simultaneously.

GET /api/v1/regulators/search?q={query}&max_items={limit}

Parameters:

Parameter	Type	Required	Description
`q`	string	Yes	Search query (drug name, active ingredient)
`max_items`	integer	No	Maximum results per agency (default: 50)

Response:

[
  {
    "pais": "United States",
    "agencia": "FDA",
    "nombre_medicamento": "Acetaminophen Tablets",
    "sustancia_activa": "Acetaminophen",
    "forma_farmaceutica": "Tablet",
    "concentracion": "500mg",
    "titular": "Generic Pharma Inc.",
    "estado": "Autorizado",
    "numero_registro": "NDA021234",
    "enlace": "https://www.accessdata.fda.gov/..."
  },
  {
    "pais": "España",
    "agencia": "AEMPS",
    "nombre_medicamento": "Paracetamol 500mg comprimidos",
    "sustancia_activa": "Paracetamol",
    "forma_farmaceutica": "Comprimidos",
    "concentracion": "500mg",
    "titular": "Laboratorios Farma SA",
    "estado": "Autorizado",
    "numero_registro": "65123",
    "enlace": "https://cima.aemps.es/cima/..."
  }
]

Schema: MedRecord (types.py:4-14) Example:

curl -X GET "https://api.vigia.app/api/v1/regulators/search?q=paracetamol&max_items=10" \
  -H "Authorization: Bearer <token>"

Search Specific Agency

Query a single regulatory agency.

GET /api/v1/regulators/search/{agency}?q={query}&max_items={limit}

Parameters:

Parameter	Type	Required	Description
`agency`	string	Yes	Agency code: `fda`, `ema`, `aemps`, `digemid`, etc.
`q`	string	Yes	Search query
`max_items`	integer	No	Maximum results (default: 50)

Supported Agencies:

Code	Agency	Country/Region
`fda`	Food and Drug Administration	United States
`ema`	European Medicines Agency	European Union
`aemps`	Agencia Española de Medicamentos	Spain
`digemid`	Dirección General de Medicamentos	Peru
`invima`	Instituto Nacional de Vigilancia	Colombia
`anvisa`	Agência Nacional de Vigilância Sanitária	Brazil
`anmat`	Administración Nacional de Medicamentos	Argentina

Example:

curl -X GET "https://api.vigia.app/api/v1/regulators/search/fda?q=ibuprofen&max_items=25" \
  -H "Authorization: Bearer <token>"

FDA Integration

Direct access to FDA medical device recalls and safety communications. Base Path: /api/v1/fda Features:

Medical device recalls
Early alerts and safety communications
Automatic English-to-Spanish translation
AI-powered product categorization (when GEMINI_API_KEY configured)

Search FDA

GET /api/v1/fda/search?q={query}&max_results={limit}

Parameters:

Parameter	Type	Required	Description
`q`	string	Yes	Search term (device name, IFA) in Spanish or English
`max_results`	integer	No	Max results (1-25, default: 10)

Response:

[
  {
    "titulo": "Alerta temprana para el sistema de acceso vascular WATCHMAN",
    "medicamento": "Sistema de acceso\nWATCHMAN",
    "evento": "El dispositivo puede desprenderse durante el procedimiento, causando complicaciones vasculares graves.",
    "url": "https://www.fda.gov/medical-devices/medical-device-recalls/...",
    "fecha_publicada": "2024-08-05T16:00:00Z"
  }
]

Schema: FDAItem

Field	Type	Description
`titulo`	string	Translated alert title (Spanish)
`medicamento`	string	Generic device type + brand (multiline)
`evento`	string	Event description / reason for recall
`url`	string	Source URL on FDA website
`fecha_publicada`	string \| null	Publication date (ISO 8601)

Example:

curl -X GET "https://api.vigia.app/api/v1/fda/search?q=stent&max_results=5" \
  -H "Authorization: Bearer <token>"

Translation: All FDA content is automatically translated from English to Spanish using deep_translator:

Title: Translated and cleaned
Event: Summarized (1-3 sentences)
Device Type: Mapped to Spanish generic terms

AI Enhancement: When GEMINI_API_KEY is configured, Gemini 1.5 Flash refines:

Generic device categorization
Brand/model extraction
Event summarization

Implementation: backend/app/services/fda.py

VigiAccess Integration

Query the WHO VigiAccess global adverse drug reaction database. Base Path: /api/v1/vigiaccess

Search Adverse Reactions

GET /api/v1/vigiaccess/search?drug={drug}&reaction={reaction}

Parameters:

Parameter	Type	Required	Description
`drug`	string	Yes	Drug/product name
`reaction`	string	No	Specific adverse reaction

Response:

{
  "drug": "Paracetamol",
  "reactions": [
    {
      "reaction": "Hepatotoxicity",
      "count": 1523,
      "countries": 45,
      "trend": "Aumentando"
    },
    {
      "reaction": "Skin rash",
      "count": 892,
      "countries": 38,
      "trend": "Estable"
    }
  ],
  "total_reports": 12456,
  "reporting_countries": 67
}

Example:

curl -X GET "https://api.vigia.app/api/v1/vigiaccess/search?drug=paracetamol&reaction=hepatotoxicity" \
  -H "Authorization: Bearer <token>"

Product Dashboard

Get comprehensive VigiAccess statistics for a product.

GET /api/v1/vigiaccess/dashboard?product_id={id}

Response:

{
  "product_id": 123,
  "product_name": "Paracetamol",
  "total_reports": 12456,
  "serious_reports": 3421,
  "countries_reporting": 67,
  "top_reactions": [
    {"reaction": "Hepatotoxicity", "count": 1523},
    {"reaction": "Allergic reaction", "count": 1124}
  ],
  "temporal_trends": [
    {"year": 2023, "count": 2341},
    {"year": 2024, "count": 2789}
  ],
  "geographic_distribution": [
    {"country": "United States", "reports": 3456},
    {"country": "United Kingdom", "reports": 2134}
  ]
}

Features:

Global ADR statistics from 150+ countries
Comparative analysis across regions
Temporal trend analysis
Dashboard visualization data

Implementation: backend/app/routers/vigiaccess.py, backend/app/routers/vigiaccess_dashboard.py

DIGEMID Integration

Access Peru’s DIGEMID regulatory alerts and product registry. Endpoints:

# Search DIGEMID product registry
GET /api/v1/regulators/search/digemid?q={query}

# Get DIGEMID alerts via surveillance
GET /api/v1/surveillance/results?scope=national&fuente=DIGEMID

Data Sources:

Alertas Sanitarias: Health alerts and recalls
RAM (Reacciones Adversas): Adverse reaction reports
Registro Sanitario: Product authorization registry

Example:

import requests

# Search product registry
response = requests.get(
    "https://api.vigia.app/api/v1/regulators/search/digemid",
    params={"q": "ibuprofeno"},
    headers={"Authorization": f"Bearer {token}"}
)

products = response.json()

# Get recent DIGEMID alerts
response = requests.get(
    "https://api.vigia.app/api/v1/surveillance/results",
    params={
        "scope": "national",
        "query": "DIGEMID",
        "limit": 20
    },
    headers={"Authorization": f"Bearer {token}"}
)

alerts = response.json()["items"]

EMA Integration

European Medicines Agency safety updates and product information. Endpoints:

# Search EMA via regulators API
GET /api/v1/regulators/search/ema?q={query}

# Get EMA alerts via surveillance
GET /api/v1/surveillance/results?scope=external&fuente=EMA

Data Sources:

Safety Updates: Pharmacovigilance announcements
EPAR (European Public Assessment Reports): Product assessments
Direct Healthcare Professional Communications (DHPC): Urgent safety alerts

Example:

# Search EMA products
curl -X GET "https://api.vigia.app/api/v1/regulators/search/ema?q=insulin&max_items=10" \
  -H "Authorization: Bearer <token>"

# Get recent EMA safety updates
curl -X GET "https://api.vigia.app/api/v1/surveillance/results?scope=external&query=EMA&severity=Alta" \
  -H "Authorization: Bearer <token>"

Data Enrichment Pipeline

VIGIA enhances regulatory data through a multi-stage pipeline:

Raw Data Extraction

Scrape HTML from regulatory websites

Translation

Translate English content to Spanish using deep_translator

Product Normalization

Map brand names to generic device/drug types

AI Enhancement (Optional)

Use Gemini 1.5 Flash to refine categorization and summarize events

Storage

Store normalized data in SurveillanceItem model

Translation Service

Implementation: backend/app/services/fda.py:45-73

from deep_translator import GoogleTranslator
from functools import lru_cache

@lru_cache(maxsize=4096)
def translate_to_spanish(text: str) -> str:
    """Translate English to Spanish with caching."""
    if len(text) <= 4500:
        return GoogleTranslator(source="auto", target="es").translate(text)
    
    # Split long texts by sentences
    parts = re.split(r"(?<=[\.\?!])\s+", text)
    translated_parts = []
    
    for part in parts:
        translated_parts.append(
            GoogleTranslator(source="auto", target="es").translate(part)
        )
    
    return " ".join(translated_parts)

Product Normalization

Generic Synonyms: backend/app/services/fda.py:150-180 Maps English device terms to Spanish categories:

GENERIC_SYNONYMS = [
    (re.compile(r"\b(catheter|ablation\s+catheter)\b", re.I), "Catéter"),
    (re.compile(r"\b(stent|endoprosthesis)\b", re.I), "Stent vascular"),
    (re.compile(r"\b(glucose\s+monitor|cgm)\b", re.I), "Monitor de glucosa (CGM)"),
    (re.compile(r"\b(pacemaker)\b", re.I), "Marcapasos"),
    (re.compile(r"\b(defibrillator)\b", re.I), "Desfibrilador"),
]

Brand Detection: backend/app/services/fda.py:190-210 Extracts brand names using pattern matching:

BRAND_PATTERN = re.compile(r"\b([A-Z][A-Z0-9\-]{3,})\b")
BRAND_STOP_WORDS = {"ACCESS", "SYSTEM", "CATHETER", "DEVICE", "PUMP"}

def extract_brand(text: str) -> str:
    for match in BRAND_PATTERN.finditer(text):
        candidate = match.group(1)
        if candidate not in BRAND_STOP_WORDS:
            return candidate
    return ""

AI Enhancement (Gemini)

Implementation: backend/app/services/fda.py:220-270 When GEMINI_API_KEY is configured:

import google.generativeai as genai

def refine_with_ai(raw_data: dict) -> dict:
    """
    Use Gemini 1.5 Flash to normalize fields.
    
    Returns:
        {
            "titulo_es": "Translated and cleaned title",
            "evento_es": "1-3 sentence event summary",
            "producto_generico_es": "Generic device type",
            "marca_o_linea": "Brand/series if clear",
            "modelo_o_variante": "Model/lot if adds value"
        }
    """
    model = genai.GenerativeModel("gemini-1.5-flash")
    
    prompt = f"""
You are a regulatory analyst preparing health reports in SPANISH.
Return STRICT JSON with this form:

{{
  "titulo_es": "...",
  "evento_es": "...",
  "producto_generico_es": "...",
  "marca_o_linea": "...",
  "modelo_o_variante": "..."
}}

Data:
- title_en: {raw_data['title_en']}
- reason_en: {raw_data['reason_en']}
- product_candidates: {raw_data['product_candidates']}
"""
    
    response = model.generate_content(prompt)
    return json.loads(response.text)

Comparison: Surveillance vs Direct Query

Feature	Scheduled Surveillance	Direct Query (Regulators API)
Data Freshness	Depends on schedule (weekly/bi-weekly)	Real-time
Coverage	All configured sources	Single agency per request
Storage	Persisted in database	Not stored
Filtering	Advanced (severity, trends, etc.)	Basic (name search)
Reports	Email reports with attachments	API response only
Use Case	Continuous monitoring, trend analysis	Ad-hoc product lookup

When to Use Surveillance:

Automated weekly/bi-weekly monitoring
Historical trend analysis
Severity-based filtering
Automated email reports

When to Use Direct Query:

Immediate product verification
Registration status lookup
One-time investigation
Real-time alert validation

Configuration

Environment Variables

# Optional: AI enhancement for FDA scraping
GEMINI_API_KEY=your_gemini_api_key_here

# Regulator API configuration
REQUEST_TIMEOUT=25  # seconds
MAX_RETRIES=2

Scraper Limits

Implementation: backend/app/services/fda.py:25-30

INDEX_LIMIT = 60          # Max detail pages to scrape from index
MIN_EVENT_CHARS = 120     # Minimum paragraph length for event
REQUEST_TIMEOUT = 25      # HTTP request timeout (seconds)

Error Handling

HTTP Errors

// 404 Not Found
{
  "detail": "Agency 'invalid_agency' not found"
}

// 400 Bad Request
{
  "detail": "Query parameter 'q' is required"
}

// 502 Bad Gateway
{
  "detail": "FDA website unavailable"
}

Graceful Degradation

Scrapers include fallback strategies:

try:
    # Try AI-powered extraction
    data = extract_with_gemini(raw_html)
except Exception:
    try:
        # Fallback to rule-based extraction
        data = extract_with_rules(raw_html)
    except Exception:
        # Final fallback: basic translation only
        data = translate_basic(raw_html)

Rate Limits

External API Limits:

FDA: No official rate limit, but excessive requests may be blocked
EMA: No official rate limit
VigiAccess: Public API with soft limit (approx. 100 req/hour)
Translation (Google Translate): Free tier limited to 500K chars/month

Recommendation: Use scheduled surveillance for continuous monitoring. Reserve direct queries for urgent/ad-hoc needs.

Best Practices

Cache Results

Store frequently-queried products to reduce API calls.Use surveillance for continuous monitoring instead of repeated direct queries.

Combine Approaches

Surveillance: Weekly monitoring for trendsDirect Query: Immediate verification during case intake

Monitor Translation Costs

Deep Translator uses Google Translate free tier.Enable GEMINI_API_KEY for AI enhancement (requires paid API key).

Handle Errors Gracefully

Regulatory websites may be temporarily unavailable.Implement retry logic and fallback to cached data.

Integration Examples

Product Verification During Case Intake

import requests

def verify_product_registration(product_name: str, country: str, token: str) -> dict:
    """
    Verify product is registered with local regulatory authority.
    """
    agency_map = {
        "Peru": "digemid",
        "United States": "fda",
        "Spain": "aemps",
        "European Union": "ema"
    }
    
    agency = agency_map.get(country)
    if not agency:
        return {"verified": False, "reason": "Unsupported country"}
    
    response = requests.get(
        f"https://api.vigia.app/api/v1/regulators/search/{agency}",
        params={"q": product_name, "max_items": 5},
        headers={"Authorization": f"Bearer {token}"}
    )
    
    if response.status_code == 200:
        results = response.json()
        if results:
            return {
                "verified": True,
                "registration_number": results[0].get("numero_registro"),
                "holder": results[0].get("titular"),
                "status": results[0].get("estado")
            }
    
    return {"verified": False, "reason": "Product not found in registry"}

# Usage
result = verify_product_registration("Paracetamol 500mg", "Peru", token)
if result["verified"]:
    print(f"Product verified: {result['registration_number']}")
else:
    print(f"Verification failed: {result['reason']}")

Cross-Reference Surveillance Alerts

import requests

def cross_reference_alerts(drug_name: str, token: str) -> dict:
    """
    Check if drug has active alerts across multiple sources.
    """
    # 1. Check surveillance database
    surv_response = requests.get(
        "https://api.vigia.app/api/v1/surveillance/results",
        params={
            "scope": "external",
            "medicamento": drug_name,
            "severity": "Alta",
            "limit": 10
        },
        headers={"Authorization": f"Bearer {token}"}
    )
    
    surveillance_alerts = surv_response.json()["items"]
    
    # 2. Query FDA directly for latest info
    fda_response = requests.get(
        "https://api.vigia.app/api/v1/fda/search",
        params={"q": drug_name, "max_results": 5},
        headers={"Authorization": f"Bearer {token}"}
    )
    
    fda_alerts = fda_response.json()
    
    # 3. Check VigiAccess for global ADR trends
    vigiaccess_response = requests.get(
        "https://api.vigia.app/api/v1/vigiaccess/search",
        params={"drug": drug_name},
        headers={"Authorization": f"Bearer {token}"}
    )
    
    vigiaccess_data = vigiaccess_response.json()
    
    return {
        "drug": drug_name,
        "surveillance_alerts": len(surveillance_alerts),
        "fda_alerts": len(fda_alerts),
        "vigiaccess_reports": vigiaccess_data.get("total_reports", 0),
        "has_active_alerts": len(surveillance_alerts) > 0 or len(fda_alerts) > 0
    }

# Usage
result = cross_reference_alerts("Paracetamol", token)
if result["has_active_alerts"]:
    print(f"WARNING: {result['surveillance_alerts']} surveillance alerts found")
    print(f"FDA alerts: {result['fda_alerts']}")
    print(f"Global VigiAccess reports: {result['vigiaccess_reports']}")

FDA Integration

Detailed FDA scraper documentation

EMA Integration

European Medicines Agency integration

DIGEMID

Peru regulatory authority

VigiAccess

WHO global database

Surveillance Overview

Main surveillance API

Schedule Management

Configure automated scraping

Code References

Component	File Location
Regulators Router	`backend/app/routers/regulators.py:1-16`
FDA Scraper	`backend/app/services/fda.py`
Regulator Types	`backend/app/services/regulators/types.py:4-14`
Search Services	`backend/app/services/regulators/scrape_regulators.py`
VigiAccess Router	`backend/app/routers/vigiaccess.py`
VigiAccess Dashboard	`backend/app/routers/vigiaccess_dashboard.py`

Authentication

ICSR

IPS Reports

Document Management

Surveillance

OCR & NLP

Products & MedDRA

Documentation Index

​Overview

​Available Sources

FDA

EMA

DIGEMID

VigiAccess

​Regulators API

​Search All Agencies

​Search Specific Agency

​FDA Integration

​Search FDA

​VigiAccess Integration

​Search Adverse Reactions

​Product Dashboard

​DIGEMID Integration

​EMA Integration

​Data Enrichment Pipeline

​Translation Service

​Product Normalization

​AI Enhancement (Gemini)

​Comparison: Surveillance vs Direct Query

​Configuration

​Environment Variables

​Scraper Limits

​Error Handling

​HTTP Errors

​Graceful Degradation

​Rate Limits

​Best Practices

Cache Results

Combine Approaches

Monitor Translation Costs

Handle Errors Gracefully

​Integration Examples

​Product Verification During Case Intake

​Cross-Reference Surveillance Alerts

​Related Documentation

FDA Integration

EMA Integration

DIGEMID

VigiAccess

Surveillance Overview

Schedule Management

​Code References

Build docs developers (and LLMs) love

Overview

Available Sources

Regulators API

Search All Agencies

Search Specific Agency

FDA Integration

Search FDA

VigiAccess Integration

Search Adverse Reactions

Product Dashboard

DIGEMID Integration

EMA Integration

Data Enrichment Pipeline

Translation Service

Product Normalization

AI Enhancement (Gemini)

Comparison: Surveillance vs Direct Query

Configuration

Environment Variables

Scraper Limits

Error Handling

HTTP Errors

Graceful Degradation

Rate Limits

Best Practices

Integration Examples

Product Verification During Case Intake

Cross-Reference Surveillance Alerts

Related Documentation

Code References