What regulatory jurisdictions does the Biocore API support?

Biocore provides regulatory intelligence from 8 major pharmaceutical markets: FDA (US), EMA (EU), PMDA (Japan), MHRA (UK), Health Canada, TGA (Australia), ANSM (France), and Swissmedic (Switzerland).

What data formats does the Biocore API return?

All API responses are returned as structured JSON. Regulatory documents are also available in PDF (original source documents), HTML (formatted web-friendly documents), and Excel (exportable spreadsheet format).

Is the Biocore API SOC 2 compliant?

Yes. Biocore maintains security controls aligned with SOC 2 Type II standards, GDPR-ready data controls, 21 CFR Part 11 audit capabilities, TLS 1.3 encryption in transit, and AES-256 encryption at rest.

How often is regulatory data updated?

Biocore ingests regulatory updates within 24 hours of publication across all 8 supported jurisdictions (FDA, EMA, PMDA, MHRA, Health Canada, TGA, ANSM, Swissmedic). Webhook events are dispatched within hours of any label change, new approval, or safety communication.

Does Biocore support GxP validation for regulated environments?

Yes. Biocore provides GxP validation documentation packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) templates. SOC 2 Type II reports and 21 CFR Part 11 feature matrices are available for enterprise customers. See biocore.com/compliance for details.

How do I authenticate with the Biocore API?

Authenticate by passing your API key as a Bearer token in the Authorization header of every request: Authorization: Bearer YOUR_API_KEY. Keys are issued per organisation over HTTPS-only endpoints, and key rotation is supported so you can revoke and reissue credentials without downtime for your integration.

What are the Biocore API rate limits?

Rate limits are applied per API key. Test keys default to 100 requests per day for evaluation, while enterprise plans include custom limits tailored to your production workloads. Contact the Biocore team to set limits that match your integration's throughput and concurrency requirements.

What webhook payload format does Biocore use?

Biocore webhooks deliver JSON payloads over HTTPS POST when a label change, new approval, or safety communication occurs. Each payload identifies the jurisdiction, drug, event type, and a link to the updated record, letting your system react to regulatory changes without polling the API.

How does Biocore's MCP server work with LLM agents?

Biocore's Model Context Protocol server, currently in development, exposes regulatory data as MCP tools an LLM agent can call directly. Instead of parsing PDFs, an agent queries structured drug-label fields in natural language and receives validated JSON it can cite in answers.

What SDKs or client libraries does Biocore provide?

Biocore provides official Python and Node.js SDKs with full OpenAPI documentation, so you can call endpoints with typed helpers instead of hand-building requests. Any language can use the REST API directly, and a Model Context Protocol server is in development for AI agent integrations.

How do I filter drug label data by jurisdiction?

Pass a jurisdiction filter on the /drugs and /regulatory-documents endpoints to scope results to FDA, EMA, PMDA, Health Canada, TGA, MHRA, ANSM, or Swissmedic. Because all jurisdictions share one normalized schema, the same query shape works across every regulatory authority Biocore supports.

API Reference

API Reference & Integration Guide

200K+ drug labels. Eight jurisdictions. One API.

Authentication, endpoints, jurisdictions, and integration patterns — everything you need to integrate the pharmaceutical data API into your pharma applications and AI workflows.

Get API Access →5-min Quick Start

Jump to

Authentication Endpoints Rate Limits Jurisdictions Search Security

cURL — Authentication

# Every request requires your API key in the header
#93C5FD">curl https://api.biocore.com/v1/drugs \
  -H #86EFAC">"Authorization: Bearer YOUR_API_KEY" \
  -H #86EFAC">"Content-Type: application/json"

# Response includes structured regulatory data
{
  #86EFAC">"data": [...],
  #86EFAC">"meta": { "total": 200000, "page": 1 }
}

200K+

Drug Labels

Jurisdictions

99.9%

Uptime SLA

Getting Started with the Biocore API

Both Biocore Slim API and Biocore MCP provide comprehensive endpoints optimised for pharmaceutical applications and AI workflows.

Schedule a Demo

Discuss your integration requirements with our team.

Get Credentials

Receive your API key and access the full documentation.

First API Call

Use the examples below to make your first request.

Go to Production

Explore all endpoints across all 8 jurisdictions.

API Authentication

All API requests require authentication using an API key. Include your key in every request header. Enterprise-grade encryption protects your keys and data.

✓API key per organisation

✓Bearer token format

✓HTTPS-only endpoints

✓Key rotation supported

cURL

# Every request requires your API key in the header
#93C5FD">curl https://api.biocore.com/v1/drugs \
  -H #86EFAC">"Authorization: Bearer YOUR_API_KEY" \
  -H #86EFAC">"Content-Type: application/json"

# Response includes structured regulatory data
{
  #86EFAC">"data": [...],
  #86EFAC">"meta": { "total": 200000, "page": 1 }
}

API Endpoints

Base URL

https://api.biocore.com/v1

All drug label API endpoints return structured JSON responses optimised for integration into your pharmaceutical applications and AI workflows.

GET

/drugs

List all drugs with pagination and filters

GET

/drugs/{id}

Get full drug details by ID

GET

/regulatory-documents

Search regulatory documents across jurisdictions

GET

/jurisdictions

List all 8 supported regulatory jurisdictions

GET

/adverse-reactions

Structured adverse reaction and safety data

POST

/search

Advanced full-text search across all data

Rate Limits

Rate limits are applied per API key to ensure fair usage and optimal performance. Limits are customised based on your organisation's deployment requirements.

Enterprise Plans

Custom rate limits tailored to your production workloads and integration requirements.

Contact Sales

Supported Jurisdictions

Biocore provides regulatory intelligence from 8 major pharmaceutical markets worldwide.

🇺🇸

FDA

DailyMed

🇪🇺

EMA

EPAR

🇯🇵

PMDA

Pharmaceuticals

🇨🇦

Health Canada

Drug Products

🇦🇺

TGA

ARTG

🇬🇧

MHRA

Yellow Card

🇫🇷

ANSM

RCP

🇨🇭

Swissmedic

Arzneimittel

Data Attribution

Important: Biocore aggregates regulatory data from authoritative pharmaceutical regulatory sources. We are not the original source of regulatory data. All regulatory information originates from official authorities (FDA, EMA, MHRA, etc.) and publicly available research databases. For critical compliance decisions, verify information directly with original regulatory sources. See our data sources for complete attribution.

Data Formats

All API responses are returned in structured JSON. Regulatory documents are available in multiple formats to support various compliance workflows.

JSON

Structured data for programmatic access

PDF

Original regulatory source documents

HTML

Formatted, web-friendly documents

Excel

Exportable spreadsheet format

Search & Filtering

Advanced search across all regulatory intelligence data. Filter by jurisdiction, date, document type, and more to streamline your workflows.

✓Filter by jurisdiction

✓Date range queries

✓Document type filters

✓Full-text search via POST /search

REST

# Filter by jurisdiction, date range, and document type
#93C5FD">GET /drugs?jurisdiction=US&date_from=2024-01-01&document_type=label

# Advanced full-text search across all regulatory data
#93C5FD">POST /search
{
  #86EFAC">"query": "atorvastatin warnings",
  #86EFAC">"jurisdictions": ["US", "EU"],
  #86EFAC">"document_types": ["label", "safety_alert"]
}

Security & Compliance

✓SOC 2 Type II✓GDPR-Ready✓21 CFR Part 11✓TLS 1.3✓AES-256

✓Security controls aligned with SOC 2 Type II standards (security documentation available for enterprise customers)

✓GDPR-ready infrastructure with data protection controls

✓Built with 21 CFR Part 11 considerations (audit trail capabilities included)

✓Encrypted data transmission (TLS 1.3) and data at rest (AES-256)

✓Regular security audits and penetration testing

✓Comprehensive audit logging and monitoring

Data Residency Options

US Residency

US data center options for customers requiring data within US jurisdiction.

EU Residency

EU data center options for GDPR-compliant data residency within the EEA.

Self-Hosted

Complete data sovereignty — zero data collection by Biocore.

Deployment-Specific Compliance

Managed Hosting

Minimal data collection (user authentication only). Customer data access limited to system operations with customer authorisation.

Self-Hosted

Zero data collection by Biocore. Customer has complete control over all data, infrastructure, and compliance.

Export Control & Cross-Border Compliance

Biocore complies with applicable export control regulations (EAR, ITAR) and implements data transfer safeguards:

✓Standard Contractual Clauses (SCCs) for EU data transfers

✓Sanctions screening (OFAC, UN, EU)

✓Encrypted data transfers (TLS 1.3)

For detailed compliance information, see our Terms of Service and Privacy Policy.

API Support & Developer Resources

Email Support

Get help from our team

[email protected]

Quick Start

First API call in under 5 minutes

View Quick Start →

Compliance

SOC 2, GDPR, 21 CFR Part 11

View Compliance →

Ready to integrate?

Get API access, sandbox credentials, and integration support from our team.

Schedule a Demo View Quick Start →

FAQ

Documentation FAQ

: Biocore provides regulatory intelligence from 8 major pharmaceutical markets: FDA (US), EMA (EU), PMDA (Japan), MHRA (UK), Health Canada, TGA (Australia), ANSM (France), and Swissmedic (Switzerland).
: Authenticate by passing your API key as a Bearer token in the Authorization header of every request: Authorization: Bearer YOUR_API_KEY. Keys are issued per organisation over HTTPS-only endpoints, and key rotation is supported so you can revoke and reissue credentials without downtime for your integration.
: All API responses are returned as structured JSON. Regulatory documents are also available in PDF (original source documents), HTML (formatted web-friendly documents), and Excel (exportable spreadsheet format).
: Yes. Biocore maintains security controls aligned with SOC 2 Type II standards, GDPR-ready data controls, 21 CFR Part 11 audit capabilities, TLS 1.3 encryption in transit, and AES-256 encryption at rest.
: Biocore ingests regulatory updates within 24 hours of publication across all 8 supported jurisdictions (FDA, EMA, PMDA, MHRA, Health Canada, TGA, ANSM, Swissmedic). Webhook events are dispatched within hours of any label change, new approval, or safety communication.
: Yes. Biocore provides GxP validation documentation packages including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) templates. SOC 2 Type II reports and 21 CFR Part 11 feature matrices are available for enterprise customers. See biocore.com/compliance for details.
: Rate limits are applied per API key. Test keys default to 100 requests per day for evaluation, while enterprise plans include custom limits tailored to your production workloads. Contact the Biocore team to set limits that match your integration's throughput and concurrency requirements.
: Biocore webhooks deliver JSON payloads over HTTPS POST when a label change, new approval, or safety communication occurs. Each payload identifies the jurisdiction, drug, event type, and a link to the updated record, letting your system react to regulatory changes without polling the API.
: Biocore's Model Context Protocol server, currently in development, exposes regulatory data as MCP tools an LLM agent can call directly. Instead of parsing PDFs, an agent queries structured drug-label fields in natural language and receives validated JSON it can cite in answers.
: Biocore provides official Python and Node.js SDKs with full OpenAPI documentation, so you can call endpoints with typed helpers instead of hand-building requests. Any language can use the REST API directly, and a Model Context Protocol server is in development for AI agent integrations.
: Pass a jurisdiction filter on the /drugs and /regulatory-documents endpoints to scope results to FDA, EMA, PMDA, Health Canada, TGA, MHRA, ANSM, or Swissmedic. Because all jurisdictions share one normalized schema, the same query shape works across every regulatory authority Biocore supports.