# EMA Drug Approval Watch — Daily Monitor for Pharma CI (`azureblue/ema-drug-approval-watch`) Actor Daily delta monitor of EMA new approvals, CHMP opinions and withdrawals from the official EPAR dataset. Webhook-ready alerts for Pharma Competitive Intelligence, Business Development, and Market Access teams. - **URL**: https://apify.com/azureblue/ema-drug-approval-watch.md - **Developed by:** [azureblue](https://apify.com/azureblue) (community) - **Categories:** Developer tools, Business - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, NaN bookmarks - **User rating**: No ratings yet ## Pricing Pay per event 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/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/platform/integrations/mcp.md). If your project is in a different language, use 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 Approval Watch — Daily Monitor for Pharma CI & Market Access **Daily delta monitoring of EMA new drug approvals, CHMP opinions, indication updates and withdrawals — for Pharma Competitive Intelligence, Business Development, and Market Access teams.** Built on the official EMA EPAR dataset. Pushes a structured alert per new or changed authorisation. Optional webhook delivers each alert to Slack, Teams, your data pipeline, or any HTTPS endpoint within seconds. --- ### What this Actor does This Actor watches the European Medicines Agency's official EPAR dataset on a schedule you control. On each run it: 1. Downloads the canonical xlsx export of all centrally-authorised medicines. 2. Computes a stable identity for each product (product number + auth date + status) and **diffs against the seen-set in its KV store**. 3. Pushes only the **new or changed** records to the dataset — never duplicates. 4. Optionally fires a **HMAC-signed webhook** for every new alert. 5. Charges the buyer once per calendar month for the subscription, plus per pushed alert. Run it on an Apify Schedule (daily/hourly/weekly — your choice). First run rebuilds the baseline; subsequent runs deliver only the delta. --- ### Use Cases — $-impact framing #### 1. Pharma Competitive Intelligence — react within hours of an EMA approval A pharma CI analyst monitors approvals in their indication area (e.g. NSCLC). The day a competitor's drug gets EMA marketing authorisation, the alert lands in their Slack channel with active substance, MAH, indication, and EPAR link. **Time-to-insight: minutes vs. weeks of manual EMA portal trawling.** #### 2. Market Access — early signal for AMNOG / NICE / HAS prep A German market-access lead filters `therapeuticAreaFilter: ["Oncology"]` and pipes alerts into their internal AMNOG-prep tracker. New oncology approvals are auto-routed to the dossier owner with the EPAR pre-populated. **Saves 4-6 weeks of preparation time per submission**, the difference between hitting and missing an early reimbursement window. #### 3. BD scouting — never miss a license-in opportunity A biotech BD team monitors withdrawals + indication-changes on small-MAH products as proxies for divestment / partnering signals. A weekly digest highlights products from MAHs <€100M revenue that just received negative CHMP opinions or partial withdrawals — **early-stage license-in candidates** before they hit the broker market. --- ### Output Each dataset item conforms to the unified `RegulatorAlert` schema shared across this publisher's Tier-A monitoring actors (FDA Watch, Swissmedic+MHRA+HC, BfArM/PEI, …). Buyers subscribed to multiple regulators get **identical column structure** for trivial UNION ALL. #### Example item ```json { "scrapedAt": "2026-05-06T07:30:00.000Z", "sourceUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda", "sourceDomain": "ema.europa.eu", "actorVersion": "1.0.0", "dataHash": "9c1f...e5", "regulator": "EMA", "alertType": "approval-update", "recordId": "EMEA/H/C/003820", "changeKind": "new", "productName": "Keytruda", "activeSubstance": "pembrolizumab", "inn": "pembrolizumab", "atcCode": "L01FF02", "manufacturer": "Merck Sharp & Dohme B.V.", "therapeuticArea": "Carcinoma, Non-Small-Cell Lung", "indication": "Pembrolizumab as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours...", "publishedAt": "2026-05-05", "effectiveAt": "2026-05-05", "severity": null, "summary": "Keytruda: New indication added — adjuvant treatment of high-risk NSCLC after surgery.", "rawSnippet": null, "documents": [ { "kind": "EPAR", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda", "title": "Keytruda" } ], "extras": { "status": "Authorised", "orphan": false } } ```` #### Webhook payload If you set `webhookUrl`, every new alert is also POSTed: ```json { "eventId": "9c1f...e5", "eventType": "ema.approval-update", "actor": "ema-drug-approval-watch", "emittedAt": "2026-05-06T07:30:01.123Z", "schemaVersion": 1, "data": { /* the alert object above */ } } ``` The header `X-Azureblue-Signature: sha256=` is included if you set `webhookSecret` — verify it server-side with HMAC-SHA256 over the raw body. *** ### Pricing Two-tier PAY\_PER\_EVENT model: | Event | Charge | When it fires | |---|---|---| | **Monthly subscription** | **$79** | Once per calendar month per user, on first delta-mode run | | **Per alert** | **$0.02** | Per new/changed record pushed to the dataset | A typical pharma CI buyer running this daily on EU oncology approvals sees ~15-30 alerts/month: **$79 + ~$0.30/mo ≈ $80/mo all-in**. Compare to ~4 hours/week of manual EMA portal monitoring at €100/h fully-loaded. **Trial mode** (`mode: "trial"`) returns 5 results, no charges, no state writes — perfect for evaluating before subscribing. *** ### Compliance - **Public-data only** — sources from the EMA's official EPAR dataset (https://www.ema.europa.eu) which is published under EU re-use terms. - **No PHI, no patient data** — the EPAR is a list of authorised medicines, not patient records. - **GDPR Art. 6(1)(f) basis** — legitimate-interest scraping of public regulatory data. The buyer is responsible for their downstream use of the data. - **Audit log** — every fetch is recorded in the actor's KV store (URL + timestamp, no PII) so you can prove compliance to internal audit. *** ### Sister Actors — same publisher, complementary coverage - [`ema-drug-approval-scraper`](https://apify.com/azureblue/ema-drug-approval-scraper) — full EPAR snapshot + filters (sister: lookup, no monitoring) - [`fda-drug-approval-watch`](https://apify.com/azureblue/fda-drug-approval-watch) — same alert schema, FDA Drugs@FDA + recalls + warning letters - [`bfarm-pei-pharmacovigilance-monitor`](https://apify.com/azureblue/bfarm-pei-pharmacovigilance-monitor) — German PV alerts (Rote-Hand-Briefe, BfArM Risikoinformationen, PEI Sicherheitsmeldungen) - [`clinical-trials-scraper`](https://apify.com/azureblue/clinical-trials-scraper) — ClinicalTrials.gov lookup - [`ctis-watch`](https://apify.com/azureblue/ctis-watch) — EU Clinical Trials Information System monitor *** ### Changelog See `CHANGELOG.md`. # Actor input Schema ## `mode` (type: `string`): Delta is the recurring-revenue mode: pushes only items unseen by the actor's KV store. Snapshot rebuilds the seen-set from scratch. Trial bypasses charges and state — perfect for evaluating before subscribing. ## `therapeuticAreaFilter` (type: `array`): Substring match (case-insensitive) on the EMA Therapeutic Area (MeSH) field. Empty = no filter. Examples: "Oncology", "Cardiovascular", "Diabetes Mellitus". ## `approvedFrom` (type: `string`): Restrict snapshot output to medicines authorised on or after this date. Format: YYYY-MM-DD. ## `webhookUrl` (type: `string`): POST endpoint that receives one JSON payload per new alert. Test with https://webhook.site to inspect payloads. Failed deliveries land in the actor's KV store under `webhook.dlq.*` for replay. ## `webhookSecret` (type: `string`): If set, every webhook request includes `X-Azureblue-Signature: sha256=` so your endpoint can verify the call came from this actor. ## `maxResults` (type: `integer`): Hard cap on dataset items per run. Trial mode is capped at 5 regardless. ## Actor input object example ```json { "mode": "delta", "therapeuticAreaFilter": [], "approvedFrom": "2024-01-01", "maxResults": 200 } ``` # Actor output Schema ## `dataset` (type: `string`): Open the run's default dataset to view, filter and export the alerts. # 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 '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "therapeuticAreaFilter": [] }; // Run the Actor and wait for it to finish const run = await client.actor("azureblue/ema-drug-approval-watch").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 '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "therapeuticAreaFilter": [] } # Run the Actor and wait for it to finish run = client.actor("azureblue/ema-drug-approval-watch").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "therapeuticAreaFilter": [] }' | apify call azureblue/ema-drug-approval-watch --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=azureblue/ema-drug-approval-watch", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "EMA Drug Approval Watch — Daily Monitor for Pharma CI", "description": "Daily delta monitor of EMA new approvals, CHMP opinions and withdrawals from the official EPAR dataset. Webhook-ready alerts for Pharma Competitive Intelligence, Business Development, and Market Access teams.", "version": "1.0", "x-build-id": "0apnGiXYBikGjyVe0" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/azureblue~ema-drug-approval-watch/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-azureblue-ema-drug-approval-watch", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/azureblue~ema-drug-approval-watch/runs": { "post": { "operationId": "runs-sync-azureblue-ema-drug-approval-watch", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/azureblue~ema-drug-approval-watch/run-sync": { "post": { "operationId": "run-sync-azureblue-ema-drug-approval-watch", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "properties": { "mode": { "title": "Run mode", "enum": [ "delta", "snapshot", "trial" ], "type": "string", "description": "Delta is the recurring-revenue mode: pushes only items unseen by the actor's KV store. Snapshot rebuilds the seen-set from scratch. Trial bypasses charges and state — perfect for evaluating before subscribing.", "default": "delta" }, "therapeuticAreaFilter": { "title": "Therapeutic area filter (optional)", "type": "array", "description": "Substring match (case-insensitive) on the EMA Therapeutic Area (MeSH) field. Empty = no filter. Examples: \"Oncology\", \"Cardiovascular\", \"Diabetes Mellitus\".", "items": { "type": "string" } }, "approvedFrom": { "title": "Approved on/after (snapshot mode only)", "pattern": "^\\d{4}-\\d{2}-\\d{2}$", "type": "string", "description": "Restrict snapshot output to medicines authorised on or after this date. Format: YYYY-MM-DD." }, "webhookUrl": { "title": "Webhook URL (optional)", "type": "string", "description": "POST endpoint that receives one JSON payload per new alert. Test with https://webhook.site to inspect payloads. Failed deliveries land in the actor's KV store under `webhook.dlq.*` for replay." }, "webhookSecret": { "title": "Webhook HMAC secret (optional)", "type": "string", "description": "If set, every webhook request includes `X-Azureblue-Signature: sha256=` so your endpoint can verify the call came from this actor." }, "maxResults": { "title": "Max results per run", "minimum": 1, "maximum": 5000, "type": "integer", "description": "Hard cap on dataset items per run. Trial mode is capped at 5 regardless.", "default": 200 } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```