FDA Drug Approvals Monitor: EMA & Health Canada

Drug Approvals Monitor tracks new drug approvals and medicine status changes from three regulators. It reads the US FDA (Drugs@FDA), the European Medicines Agency (EMA) and Health Canada's Drug Product Database. It returns every event in one schema.

Use it to follow new drug approvals, generic and biosimilar entries, label and variation decisions, withdrawals, suspensions and cancellations. It suits regulatory affairs teams, market access analysts, pharma competitive intelligence and AI agents.

Schedule it daily with monitor mode on. Each run then returns only events you have not seen before.

Every event carries standard flags. Filter for FDA novel drug approvals, orphan medicines, priority reviews, EMA conditional approvals, PRIME or advanced therapy medicines in one click.

Drug approvals: regulators covered

Regulator	Data source	What one event means	Events in the last 30 days (21 October 2026)
FDA (United States)	openFDA Drugs@FDA API	One approved or tentatively approved submission: an original application or a supplement	382
EMA (European Union)	EMA medicines data report (JSON)	One dated step: CHMP opinion, marketing authorisation, European Commission decision, refusal, withdrawal, suspension	101 human medicines
Health Canada	Drug Product Database API	One product status change: approved, marketed, dormant, cancelled	205 human products
FDA drug recalls (opt-in)	openFDA drug enforcement reports	One drug recall notice, with its class (Class I, II or III), reason and recalling firm	67 recalls (24 Sep to 23 Oct 2026)

Counts change every day. openFDA refreshes its data weekly. EMA and Health Canada refresh daily.

Drug approvals data you get

Field	Meaning
regulator	FDA, EMA or Health Canada
country	US, EU or CA
eventDate	Date of the event, YYYY-MM-DD
eventType	Original application, Supplement, Marketing authorisation, European Commission decision, Product status change and similar
eventDetail	FDA submission class and review priority. EMA procedure number and flags such as orphan or biosimilar. Health Canada first market date
status	Shared status: approved, tentative-approval, opinion-positive, refused, withdrawn, suspended, marketed, dormant, cancelled-post-market and others
statusOriginal	Status as the regulator wrote it
productName	Brand or medicine name
activeIngredients	Active ingredients, separated by semicolons
company	Applicant, sponsor or marketing authorisation holder
applicationNumber	FDA application number (NDA, ANDA, BLA), EMA product number or Health Canada DIN
productCategory	Human, Veterinary, Disinfectant or Radiopharmaceutical
dosageForms, routes	Dosage forms and routes (FDA and Health Canada)
therapeuticArea	FDA pharmacologic class or EMA therapeutic area
atcCode	ATC code (EMA and Health Canada)
documentUrls	FDA approval letters and labels for the submission
flags	Standard flags, listed below
applicationType	FDA NDA, ANDA or BLA. Centralised for EMA
submissionClass	FDA submission class, for example "Type 1 - New Molecular Entity", "Efficacy" or "Labeling"
reviewPriority	FDA priority or standard. EMA accelerated when the medicine had accelerated assessment
therapeuticIndication	EMA approved indication text
opinionDate	EMA CHMP or CVMP opinion date
firstApprovalDate	FDA original approval date of the application, or EMA marketing authorisation date
currentStatus	Status today: EMA medicine status, or FDA marketing status (Prescription, Over-the-counter, Discontinued)
recallClass	FDA recalls only: Class I, Class II or Class III. Null on other rows
sourceUrl	Link to the medicine on the regulator's site
sourceAttribution	Source acknowledgement required by the data licence

Drug approval flags

Flag	FDA	EMA	Meaning
novel	Yes		Original approval of a new molecular entity (Drugs@FDA submission class Type 1)
new-molecular-entity	Yes		Submission class Type 1, original or supplement
orphan	Yes	Yes	Orphan designation on the FDA submission, or EMA orphan medicine
priority-review	Yes		FDA priority review
generic	Yes	Yes	FDA ANDA, or EMA generic
biosimilar	Yes	Yes	FDA biosimilar submission class, or EMA biosimilar
conditional-approval		Yes	EMA conditional marketing authorisation
exceptional-circumstances		Yes	EMA authorisation under exceptional circumstances
advanced-therapy		Yes	EMA advanced therapy medicinal product
prime		Yes	EMA PRIME priority medicine
accelerated-assessment		Yes	EMA accelerated assessment
additional-monitoring		Yes	EMA additional monitoring (black triangle)

Health Canada events have no flags. The FDA's own yearly list of novel drug approvals can differ slightly from the novel flag. Some FDA biologic originals carry no submission class in Drugs@FDA.

Sample FDA record from a test run:

{
  "id": "fda:NDA220415:ORIG-1:AP",
  "regulator": "FDA",
  "country": "US",
  "eventDate": "2026-09-25",
  "eventType": "Original application",
  "eventDetail": "Type 1 - New Molecular Entity; standard review",
  "status": "approved",
  "statusOriginal": "Approved",
  "productName": "JUVMO; JUVMO (COPACKAGED)",
  "activeIngredients": "TAVAPADON",
  "company": "ABBVIE",
  "applicationNumber": "NDA220415",
  "dosageForms": "TABLET",
  "routes": "ORAL",
  "documentUrls": [
    "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220415Orig1s000ltr.pdf",
    "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220415Orig1s000lbl.pdf"
  ],
  "flags": ["novel", "new-molecular-entity"],
  "applicationType": "NDA",
  "submissionClass": "Type 1 - New Molecular Entity",
  "reviewPriority": "standard",
  "firstApprovalDate": "2026-09-25",
  "currentStatus": "Prescription",
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220415"
}

Sample European Medicines Agency (EMA) record from a test run with the orphan flag filter:

{
  "id": "ema:EMEA/H/C/004827:ec-decision:2026-08-27",
  "regulator": "EMA",
  "eventDate": "2026-08-27",
  "eventType": "European Commission decision (latest change)",
  "eventDetail": "VR/0000367485; orphan medicine; conditional approval; advanced therapy; PRIME",
  "status": "approved",
  "productName": "Hemgenix",
  "activeIngredients": "Etranacogene dezaparvovec",
  "company": "CSL Behring GmbH",
  "applicationNumber": "EMEA/H/C/004827",
  "therapeuticArea": "Hemophilia B",
  "atcCode": "B02BD",
  "flags": ["orphan", "conditional-approval", "advanced-therapy", "prime", "additional-monitoring"],
  "applicationType": "Centralised",
  "therapeuticIndication": "Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.",
  "opinionDate": "2022-12-15",
  "firstApprovalDate": "2023-02-20",
  "currentStatus": "Authorised",
  "sourceUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/hemgenix"
}

Some fields stay empty for some regulators. EMA's report has no dosage form or route. Health Canada has no therapeutic area. Some FDA tentative approvals list no product details. The Actor never guesses a missing value.

Drug approvals monitoring: how to use it

1. Pick the regulators. Leave the list empty for all three.
2. Set the date window. The default is the last 30 days.
3. Add keywords to watch an active ingredient, a company or a therapeutic area. Example: semaglutide, pfizer, oncology.
4. Optional: pick flags such as novel or orphan to keep only those events.
5. Turn on Monitor mode and schedule the Actor daily. Each run returns only new events.
6. Connect the output to Google Sheets, Slack, email or your CRM through Apify integrations.

Keyword matching

Keywords search the product name, active ingredients, company, application number, therapeutic area, ATC code and EMA therapeutic indication. They match whole words and ignore case. pfizer matches "PFIZER INC" and "Pfizer Europe MA EEIG".

Monitor mode

Monitor mode remembers which events it returned before. Use a different Monitor name (monitorName) for each watch list. Example: one name for your competitors and another for one therapeutic area.

Drug approvals input options

Option	Default	Meaning
Regulators	fda, ema, hc	fda, ema, hc, fda-recalls (drug recalls, off by default)
Recall classes	All three	Class I, Class II, Class III. Used with fda-recalls
Days back	30	Events from this many days before the end date
Start date, End date	Empty	Optional fixed window, YYYY-MM-DD
Keywords	None	Keep only matching events
Only events with these flags	None	Keep only events with at least one chosen flag, for example novel or orphan
Human medicines only	On	Skip veterinary medicines, disinfectants and radiopharmaceuticals
Monitor mode	Off	Return only events not returned before
Monitor name	default	Name of the monitor memory. The old field name stateKey still works
Maximum events	100	Stop after this many events, newest first. Set 0 for no limit

Drug approvals pricing

The Actor uses pay-per-event pricing:

Event	Free plan	GOLD plan and higher
Run start	$0.005	$0.005
Medicine event	$0.003 ($3.00 per 1,000)	$0.0024 ($2.40 per 1,000)

Events in one run	Free plan	GOLD plan and higher
100	$0.305	$0.245
1,000	$3.005	$2.405

Costs include the run start fee.

Events skipped by your filters or by monitor mode cost nothing. A recall row costs the same as any other event. Check the Pricing tab for the current price.

Drug approvals example: input and output

This input reads EMA decisions from the last 90 days that mention Pfizer, and stops at 5 events:

{
  "regulators": ["ema"],
  "keywords": ["pfizer"],
  "daysBack": 90,
  "maxItems": 5
}

One record from that run on 21 October 2026:

{
  "id": "ema:EMEA/H/C/004696:ec-decision:2026-10-05",
  "regulator": "EMA",
  "country": "EU",
  "eventDate": "2026-10-05",
  "eventType": "European Commission decision (latest change)",
  "eventDetail": "VR/0000372519; biosimilar",
  "status": "approved",
  "statusOriginal": "Authorised",
  "productName": "Ruxience",
  "activeIngredients": "rituximab",
  "company": "Pfizer Europe MA EEIG",
  "applicationNumber": "EMEA/H/C/004696",
  "productCategory": "Human",
  "dosageForms": null,
  "routes": null,
  "therapeuticArea": "Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus",
  "atcCode": "L01XC02",
  "documentUrls": [],
  "sourceUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience",
  "sourceAttribution": "Source: European Medicines Agency (EMA), medicines data report. EMA is the source of this material.",
  "scrapedAt": "2026-10-21T10:25:08.081Z"
}

This input returns FDA novel drug approvals and orphan medicines from both agencies in the last 90 days:

{
  "regulators": ["fda", "ema"],
  "flags": ["novel", "orphan"],
  "daysBack": 90,
  "maxItems": 50
}

Drug approvals data sources and licences

• openFDA data, recalls included, is public domain under CC0. openFDA says not to rely on it for medical decisions.
• EMA allows reuse, including commercial reuse, when EMA is acknowledged as the source. Each EMA record carries that acknowledgement in sourceAttribution.
• Health Canada data is published under the Open Government Licence - Canada. Each record carries the required attribution.
• The Actor reads public APIs and files that need no login. It collects product and company facts only. It does not collect personal data.
• Always check the regulator's site before you act on a record.

Drug approvals run time

A 30-day run of all three regulators takes about 30 seconds. The regulators and Health Canada's product tables are read at the same time.

Drug approvals FAQ

Does it cover medical devices or biologics outside Drugs@FDA?

No. FDA data comes from Drugs@FDA, which covers drugs and the biologics that CDER reviews. Devices and CBER vaccines are outside its scope.

Why do I see Health Canada "marketed" events?

Health Canada records when a company starts selling an approved product. That is a status change, so the Actor reports it. Filter on status if you want approvals only.

How do I get only FDA novel drug approvals?

Set regulators to fda and flags to novel. Each event is the original approval of a new molecular entity, with sponsor, review priority, approval letter and label links.

Can I get the full history?

Yes. Set a start date in the past and set maximum events to 0. One year of all three regulators is about 10,000 events.

Does it track label changes?

Yes. FDA supplements and EMA variation decisions cover label changes. Each one is a separate event with its own date.

Can an AI agent use it?

Yes. Agents can find and run it through the Apify MCP server or the Apify API. The output uses one schema for all regulators.

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Support

Report a problem in the Issues tab. Include the run link.