Pharma Regulatory Intelligence — FDA, EMA & Clinical Trials

Search drug approvals, device recalls and clinical trials in one place. Results come from three official public sources:

• openFDA — FDA-approved drug labels (marketed products) and drug/device enforcement (recall) records.
• EMA — centrally authorised medicines from the European Medicines Agency's public JSON data file.
• ClinicalTrials.gov — registered clinical studies from the US National Library of Medicine.

Each record is normalised into one clean JSON shape with the identifiers, dates, sponsor organisation (company or institution, never an individual investigator), status, indication, therapeutic area, trial phase and source URL. No login, no proxy, no browser. No personal data.

What can you do with it?

• Pharma suppliers and CROs: "Which sponsors are running Phase 2/3 trials in diabetes, and what drugs or devices in that space were recalled recently?" — sales targeting and safety context.
• Investors and analysts: "Approvals, trial phases and recall risk for a therapeutic area" — pipeline screening and diligence.
• Researchers and medical writers: "The current trial landscape and approved products for Alzheimer disease" — one query, three sources.
• AI agents: one tool call answers "FDA approvals and active trials for diabetes in 2026" with structured, cited data.

Data source and coverage

Sources	openFDA drug label (/drug/label.json), openFDA drug enforcement (/drug/enforcement.json), openFDA device recall (/device/recall.json), EMA medicines JSON, ClinicalTrials.gov API v2
Coverage	FDA-approved marketed drug products; FDA drug and device recalls; EMA centrally authorised human and veterinary medicines; 500,000+ registered clinical studies
Freshness	openFDA updates daily; EMA updates its JSON file twice a day (06:00 and 18:00 CET); ClinicalTrials.gov updates continuously. Each run reads the live sources
Personal data	None. Sponsor fields contain company or institution names only. No investigators, patients, phone numbers or emails
Rate limits	The Actor sends at most 4 requests per second and backs off when a source is busy. openFDA allows 240 requests/minute without an API key

FDA approvals: the Actor uses the openFDA drug label endpoint, which lists FDA-approved marketed drug products and carries the indication text. The application number links to the Drugs@FDA approval record. The primary date is the label's effective date. If you need the original approval date only, use the applicationNumber identifier to look it up in Drugs@FDA.

EMA: the Actor downloads the EMA medicines JSON file (about 7 MB) and filters it locally by therapeutic area, keywords, status (Authorised) and decision date. The first run of a session takes about 10–20 seconds because of the download.

The data is supplied by the regulators. openFDA states that results are unvalidated and should not be relied on for medical decisions. EMA data is reusable under the EU Open Data Directive; attribute the European Medicines Agency. ClinicalTrials.gov data is public domain. This Actor is independent and is not endorsed by the FDA, EMA or NIH.

Input

Every filter is optional. With an empty input you get the newest 100 records from the last 12 months across FDA approvals, FDA recalls, EMA approvals and ClinicalTrials.gov trials.

Field	What it does
therapeuticArea	Disease or therapeutic area, e.g. "diabetes", "Alzheimer disease", "oncology". Used as the ClinicalTrials.gov condition query, the openFDA label indication search and the EMA local filter
keywords	Extra terms matched against brand names, generic names, trial titles and recall descriptions. Combined with the therapeutic area using AND
agency	both, fda or ema. FDA covers US drug labels and drug/device recalls. EMA covers EU centrally authorised medicines. ClinicalTrials.gov is included for trial records regardless of agency
recordType	all, approval, recall or trial
phase	Trial phases: phase1, phase2, phase3, phase4, na. Empty = all. Only applies to trial records
sponsorType	all, industry, academic or government. Filters ClinicalTrials.gov lead sponsor class
dateFrom / dateTo	YYYY-MM-DD or a relative period like "12 months", "90 days". Default: last 12 months up to today
maxResults	Default 100, up to 5,000
includeRaw	Adds the complete raw source object under raw

Example input

Diabetes approvals, recalls and trials from 2025–2026, ten records:

{
    "therapeuticArea": "diabetes",
    "agency": "both",
    "recordType": "all",
    "dateFrom": "2025-01-01",
    "dateTo": "2026-12-31",
    "maxResults": 10
}

Output

One record per approval, recall or trial. These five records come from a live run on 3 Nov 2026 with the example input (maxResults: 5), one from each source:

[
    {
        "id": "fda-approval-ANDA078043",
        "recordType": "approval",
        "agency": "fda",
        "source": "openFDA Drug Label (FDA-approved)",
        "title": "Amlodipine Besylate",
        "brandName": "Amlodipine Besylate",
        "genericName": "amlodipine besylate",
        "sponsor": "Lupin Pharmaceuticals, Inc.",
        "sponsorType": "industry",
        "status": "Approved",
        "indication": "1 INDICATIONS AND USAGE Amlodipine besylate tablets are calcium channel blocker ...",
        "therapeuticArea": "diabetes",
        "phase": null,
        "primaryDate": "2026-04-20",
        "secondaryDate": null,
        "identifiers": { "applicationNumber": "ANDA078043" },
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078043"
    },
    {
        "id": "fda-device-recall-Z-0088-2027",
        "recordType": "recall",
        "agency": "fda",
        "source": "openFDA Device Recall",
        "title": "Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 ...",
        "brandName": null,
        "genericName": null,
        "sponsor": "Medtronic MiniMed, Inc.",
        "sponsorType": "industry",
        "status": "Recall",
        "indication": "Some MiniMed Flex insulin pumps were released with missing ...",
        "therapeuticArea": "diabetes",
        "phase": null,
        "primaryDate": "2026-08-20",
        "secondaryDate": null,
        "identifiers": { "recallNumber": "Z-0088-2027" },
        "sourceUrl": "https://api.fda.gov/device/recall.json?search=product_res_number:%22Z-0088-2027%22"
    },
    {
        "id": "ema-EMEA/H/C/006615",
        "recordType": "approval",
        "agency": "ema",
        "source": "EMA Medicines",
        "title": "Liraglutide STADA",
        "brandName": "Liraglutide STADA",
        "genericName": "liraglutide",
        "sponsor": "STADA Arzneimittel AG",
        "sponsorType": "industry",
        "status": "Authorised",
        "indication": "Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus ...",
        "therapeuticArea": "Diabetes Mellitus",
        "phase": null,
        "primaryDate": "2026-10-29",
        "secondaryDate": "2026-10-29",
        "identifiers": { "emaProductNumber": "EMEA/H/C/006615" },
        "sourceUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/liraglutide-stada"
    },
    {
        "id": "ct-NCT07670572",
        "recordType": "trial",
        "agency": "clinicaltrials",
        "source": "ClinicalTrials.gov",
        "title": "Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes",
        "brandName": null,
        "genericName": null,
        "sponsor": "Marmara University",
        "sponsorType": "other",
        "status": "RECRUITING",
        "indication": "Type 1 Diabetes, Children, Activity, Insulin, Self Management, Parent",
        "therapeuticArea": "Type 1 Diabetes",
        "phase": "NA",
        "primaryDate": "2026-10-05",
        "secondaryDate": null,
        "identifiers": { "nctId": "NCT07670572" },
        "sourceUrl": "https://clinicaltrials.gov/study/NCT07670572"
    }
]

The actual run also returned a second FDA device recall (Z-0732-2026, "Diabetes HbA1c Test", GET TESTED INTERNATIONAL AB). Dates are YYYY-MM-DD. Fields a source did not supply are null. The dataset has an Overview table view. The run also writes a RUN_SUMMARY record (saved, total matches, requests, filters) to the key-value store.

Pricing

Pay per result, no subscription and no start fee:

Event	Price
pharma-record: one approval, recall or trial written to the dataset	$0.02 ($20 per 1,000)

• You only pay for records you receive. Filtered-out records are free.
• The Actor never returns more records than your run's maximum cost allows; it stops cleanly at that limit.
• Examples: a 10-result query costs $0.20; a 100-result query costs $2.00; a 500-result query costs $10.00.
• Set the run's maximum cost high enough for your query. The default local test budget in this repo's environment stopped at one record; on the Apify platform, set the max cost to cover the number of records you expect.

Use with AI agents (MCP)

The input schema is written for language models: every filter has a plain-English description and examples.

Add the Apify MCP server with only this Actor enabled:

https://mcp.apify.com/?tools=<username>/pharma-regulatory-intelligence

Example questions the agent can answer with a single call:

• "Which companies are sponsoring Phase 3 diabetes trials in 2026?"
• "List FDA drug approvals and device recalls for insulin pumps since 2025."
• "What EMA-authorised medicines target Alzheimer disease, and what trials are recruiting?"

Tips for agents:

• Keep maxResults small (10–50) for exploratory questions.
• Use recordType: "trial" with phase: ["phase2", "phase3"] to focus on late-stage trials.
• Use agency: "ema" for EU-only approvals; agency: "fda" for US drug labels and recalls.

Run it from code

curl -X POST "https://api.apify.com/v2/acts/<username>~pharma-regulatory-intelligence/run-sync-get-dataset-items?token=$APIFY_TOKEN" \
  -H 'Content-Type: application/json' \
  -d '{"therapeuticArea":"diabetes","agency":"both","recordType":"all","dateFrom":"2025-01-01","maxResults":25}'

FAQ

Why does an FDA approval record have a label effective date instead of an approval date? The openFDA drug label endpoint carries the indication text and the application number. The label's effective_time is the version date of the approved label. Use the applicationNumber to look up the original approval date in Drugs@FDA. The label endpoint is the only openFDA endpoint that pairs an indication with an approved product, so it is the best fit for the output schema.

Why are some EMA records missing? The EMA dataset covers centrally authorised medicines. Nationally authorised medicines are not included. The Actor filters to medicine_status: "Authorised" and to records with a European Commission decision date or marketing authorisation date in the requested range. Records without a usable date are excluded.

Why did my run stop early? The run hit the maximum cost you set. Each record costs $0.02. Raise the run's maximum cost or reduce maxResults. The RUN_SUMMARY key-value record shows stoppedByBudget: true when this happens.

Is this legal to use? The Actor reads only public, keyless APIs and public data files. It sends at most 4 requests per second. It returns no personal data. You are responsible for how you use the results. openFDA data is unvalidated; do not use it for medical decisions.

How fresh is the data? openFDA updates daily; EMA updates its JSON twice a day; ClinicalTrials.gov updates continuously. Each run reads the live sources.

Something looks wrong or a filter is missing? Open an issue on the Actor's Issues tab. Issues are answered within a few days.