# EMA Drug Approvals Monitor - CHMP Opinions & Authorisations (`datadeltas/ema-approvals-monitor`) Actor

Scheduled change feed for EU drug approvals: new EMA marketing authorisations, CHMP positive/negative opinions, refusals, withdrawals and suspensions since your last run. Reads the official EMA medicines register (keyless, refreshed daily) and emits only what changed - not a catalogue dump.

- **URL**: https://apify.com/datadeltas/ema-approvals-monitor.md
- **Developed by:** [Daniel Matthee](https://apify.com/datadeltas) (community)
- **Categories:**
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $20.00 / 1,000 approval event detecteds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.
Actors are written with capital "A".

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## EMA Drug Approvals Monitor — EU / CHMP Approval & Opinion Change Feed

The **change feed** for EU drug regulation. Every scheduled run downloads the
official EMA medicines register, diffs it against the previous run, and emits
one record per **regulatory event**: a new marketing authorisation, a CHMP
positive or negative opinion, a refusal, a withdrawal, a suspension. Other
tools tell you a medicine's status *now*; this actor tells you **what moved
since you last checked** — which is what a catalyst calendar, a competitive
watch list and a market-access tracker actually need.

Covers the whole EU register: ~2,700 centrally authorised human and
veterinary medicines, refreshed daily by EMA. No API key, no login, no
scraping of third-party aggregators — only EMA's own published dataset.

**This actor is EU-only by design.** US FDA approvals are a separate,
well-served market; here you get the EMA/CHMP side properly, with stable
product ids and typed transitions.

### Event types

| `eventType` | What triggers it |
|---|---|
| `new-authorisation` | A medicine's status becomes **Authorised** — the EU marketing authorisation is granted. |
| `chmp-opinion` | The committee opinion becomes **Positive** or **Negative** (CHMP for human medicines, CVMP for veterinary) — typically 1–2 months ahead of the Commission decision. |
| `withdrawal` | Withdrawn, Application withdrawn, Revoked, Suspended, Lapsed, Expired, Withdrawn from rolling review, or removed from the register entirely. |
| `status-change` | Every other transition, including **Refused** and entry into *Opinion* / *Opinion under re-examination*. The catch-all, so nothing is silently dropped. |

### First run seeds — with a head start

By design the **first run stores a baseline of the whole register**, so you
are never billed for 2,700 "changes" that are just the existing register.
But the register carries EMA's own decision dates, so the seeding run also
emits the **recent history** — every authorisation, refusal, withdrawal,
suspension and opinion dated within `sinceDays` (default **30**). You get
immediate value on run one and pure deltas from run two on. Set
`sinceDays: 0` for a silent seed.

Recommended schedule: **daily**. EMA refreshes the dataset every morning
(UTC); CHMP meets monthly, so opinion batches land in clusters.

### Example output record

```json
{
  "source": "ema-medicines",
  "productId": "EMEA/H/C/006629",
  "medicineName": "Hopledo",
  "inn": "levodopa;carbidopa",
  "marketingAuthHolder": "Zambon SpA",
  "category": "Human",
  "eventType": "new-authorisation",
  "oldStatus": null,
  "newStatus": "Authorised",
  "opinionOutcome": null,
  "therapeuticArea": ["Parkinson Disease"],
  "atcCode": "N04BA02",
  "decisionDate": "2026-08-20",
  "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/hopledo",
  "detectedAt": "2026-08-31T09:44:55Z"
}
```

`productId` is the **EMA product number** (`EMEA/H/C/…` human,
`EMEA/V/C/…` veterinary) — stable and unique for the life of the product, so
it joins cleanly to your own pipeline. `oldStatus` is the status this actor
last saw (`null` for a medicine new to the register or for a seed-run
backfill record); `newStatus` is the current one. `decisionDate` is taken
from the matching EMA date column — authorisation, refusal, withdrawal,
suspension or opinion-adopted — and is `null` when EMA has not published one.
`opinionOutcome` is populated on `chmp-opinion` records only. `url` is the
medicine's EPAR page.

### Input options

| Field | Default | What it does |
|---|---|---|
| `eventTypes` | all four | Which kinds of event to emit. Pick `chmp-opinion` alone for a pure catalyst feed. |
| `therapeuticAreas` | all | Case-insensitive substring match on the medicine's MeSH therapeutic areas, e.g. `Diabetes`, `Carcinoma, Non-Small-Cell Lung`. |
| `atcCodes` | all | ATC / ATCvet prefix match, e.g. `L01` (antineoplastics), `A10` (diabetes), `J07` (vaccines). |
| `keywords` | all | Substring match on medicine name, INN / active substance and marketing-authorisation holder, e.g. `pembrolizumab`, `Novo Nordisk`. |
| `sinceDays` | `30` | First-run backfill window in days (0–365). Ignored on later runs. |
| `maxItems` | `500` | Cap on event records per run. The baseline still updates in full. |

Filters apply at emit time — the stored baseline always reflects the full
register, so narrowing or widening a filter later never resurrects or
duplicates old events.

### Use cases

- **Biotech / pharma catalyst trading** — a CHMP positive or negative opinion
  is the tradeable EU event, and it lands weeks before the Commission
  decision. Filter to `chmp-opinion` plus your watch-list `keywords` and get
  the outcome the morning EMA publishes it.
- **Competitive intelligence** — watch a rival's `marketingAuthHolder` name
  or an ATC class and see every EU authorisation, refusal and withdrawal in
  your space without reading monthly meeting minutes.
- **Market access & pricing** — a new authorisation starts the national
  reimbursement clock in every member state. Feed authorisations straight
  into your launch tracker with the EPAR link attached.
- **Pharmacovigilance & supply** — suspensions, revocations and withdrawals
  are the events that pull a product from EU shelves; get them as records,
  not as a newsletter.

### Reliability

- **A failed download is a failed run, never a quiet day.** If EMA's dataset
  is unreachable or stops looking like the expected `{meta, data}` envelope,
  the run aborts loudly with the baseline untouched — it never empties your
  state or reports the whole register as withdrawn.
- **Exactly-once transitions.** Each status or opinion move emits one record
  and never repeats, including a medicine that disappears from the register
  (emitted once as a withdrawal, then retained in state).
- **No double-counting.** The real *Opinion → Authorised* path moves two
  fields at once; you get one `new-authorisation` record, not two.
- **Schema drift is logged, not fatal.** Unparseable rows and dates are
  warned about and skipped; the rest of the run proceeds.

### Pricing

Pay per event: a small per-run fee plus a fee per event detected. Quiet
weeks cost almost nothing; CHMP weeks deliver exactly the records worth
acting on.

### Maintenance

The EMA dataset format is checked against the official publication; if EMA
moves the download URL or renames a column, the actor is updated and the
state format keeps your baseline. Output changes within a major version are
additive only.

### Changelog

- **0.1** — initial release: full EMA medicines register (human + veterinary),
  four typed event types, first-run date backfill, therapeutic-area / ATC /
  keyword filters.

# Actor input Schema

## `eventTypes` (type: `array`):

Which kinds of EU regulatory event to push to the dataset. Default: all four. 'Status change' is the catch-all that also carries refusals and new CHMP opinion statuses, so leaving it on means nothing is silently dropped.

## `therapeuticAreas` (type: `array`):

Optional case-insensitive substring match on the medicine's MeSH therapeutic areas, e.g. "Diabetes", "Carcinoma, Non-Small-Cell Lung", "Obesity". An event is emitted when any area matches any of these. Leave empty for every therapeutic area.

## `atcCodes` (type: `array`):

Optional ATC / ATCvet code prefixes, e.g. "L01" for antineoplastics, "A10" for drugs used in diabetes, "J07" for vaccines. Matches human and veterinary codes. Leave empty for all codes.

## `keywords` (type: `array`):

Optional case-insensitive substring match on medicine name, INN / active substance and marketing-authorisation holder, e.g. "pembrolizumab", "Keytruda", "Novo Nordisk". Leave empty to monitor the whole register.

## `sinceDays` (type: `integer`):

FIRST RUN ONLY. The EMA register carries its own decision dates, so the seeding run can emit the recent history instead of nothing: authorisations, refusals, withdrawals, suspensions and CHMP opinions dated within this many days. Set 0 for a pure silent seed. Later runs ignore this and emit only genuine transitions.

## `maxItems` (type: `integer`):

Hard cap on event records emitted in one run (keeps test runs cheap). The baseline still updates in full, so capped events are not re-emitted later.

## Actor input object example

```json
{
  "eventTypes": [
    "new-authorisation",
    "chmp-opinion",
    "withdrawal",
    "status-change"
  ],
  "therapeuticAreas": [],
  "atcCodes": [],
  "keywords": [],
  "sinceDays": 30,
  "maxItems": 500
}
```

# Actor output Schema

## `records` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "therapeuticAreas": [],
    "atcCodes": [],
    "keywords": []
};

// Run the Actor and wait for it to finish
const run = await client.actor("datadeltas/ema-approvals-monitor").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "therapeuticAreas": [],
    "atcCodes": [],
    "keywords": [],
}

# Run the Actor and wait for it to finish
run = client.actor("datadeltas/ema-approvals-monitor").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "therapeuticAreas": [],
  "atcCodes": [],
  "keywords": []
}' |
apify call datadeltas/ema-approvals-monitor --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,datadeltas/ema-approvals-monitor"
        }
    }
}

```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/gMf12dVh0VMgJsE4w/builds/vp16RjgxF4aok1XBv/openapi.json