Demo: Pharmaceutical EMA Compliance

How a pharmaceutical company uses Pauhu® to monitor EMA regulatory changes, translate product information, check substance compliance, and track court rulings — in 20 minutes.

Prerequisites

• A Pauhu account (free tier: 3 requests/day, or any paid tier)
• An API key — generate one at staging.pauhu.eu/keys

All examples below use curl. The same endpoints are available through the Pauhu search interface with no code required.

1 Search for the relevant pharmaceutical regulation

Search across EUR-Lex and EMA data for the regulatory framework:

curl -X POST https://staging.pauhu.eu/search \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "query": "marketing authorisation variation excipient medicinal product",
    "sources": ["eurlex", "ema"],
    "lang": "en",
    "limit": 10
  }'

Key results:

Result: Found The three core regulations plus the EMA variation guideline. The plant protection hit (32009R1107) is a false positive — it shares terminology but applies to a different sector.

2 Check substance status in ECHA

Search for the substance across ECHA data:

curl -X POST https://staging.pauhu.eu/search \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "query": "titanium dioxide excipient cosmetic pharmaceutical",
    "sources": ["echa", "eurlex"],
    "lang": "en",
    "limit": 10
  }'

Example result for titanium dioxide (a common excipient under regulatory scrutiny):

{
  "results": [
    {
      "title": "Titanium dioxide (TiO2) — substance evaluation",
      "source": "ECHA",
      "ec_number": "236-675-5",
      "cas_number": "13463-67-7",
      "svhc_status": "candidate_list",
      "date_added": "2022-01-14",
      "concern": "suspected carcinogen (inhalation route)",
      "topics": ["chemical safety", "SVHC", "REACH"],
      "relevance": 0.94
    },
    {
      "celex": "32022R2065",
      "title": "Commission Regulation (EU) 2022/2065 — TiO2 as food additive (E 171) no longer authorised",
      "source": "EUR-Lex",
      "relevance": 0.89,
      "topics": ["food safety", "food additives", "chemical safety"]
    }
  ]
}

Result: Attention Titanium dioxide is on the SVHC candidate list and has been banned as a food additive (E 171) since 2022. The pharmaceutical excipient use is currently still permitted under Directive 2001/83/EC, but regulatory pressure is increasing. The variation dossier should address this proactively.

3 Find EMA guidance on variation procedures

Search EMA-specific data for variation guidance:

curl -X POST https://staging.pauhu.eu/search \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "query": "type II variation excipient change quality",
    "sources": ["ema"],
    "lang": "en",
    "limit": 5
  }'

EMA results include document type metadata (guideline, Q&A, reflection paper) and the relevant committee (CHMP, CMDh, PRAC):

{
  "results": [
    {
      "title": "Classification guideline — categories of variations",
      "source": "EMA",
      "document_type": "guideline",
      "committee": "CMDh",
      "reference": "EMA/CAT/C/1223/2008",
      "relevance": 0.93,
      "topics": ["pharmaceutical regulation", "marketing authorisation", "variation"]
    },
    {
      "title": "Q&A on the variation regulation",
      "source": "EMA",
      "document_type": "questions_and_answers",
      "committee": "CMDh",
      "relevance": 0.87,
      "topics": ["pharmaceutical regulation", "variation", "procedural guidance"]
    }
  ]
}

The classification guideline confirms that replacing an excipient with a different substance (not a close equivalent) is a Type II variation (category B.II.a.3(b)) — requiring a full quality dossier update and possible CHMP assessment.

4 Translate SmPC text into target languages

Translate a SmPC section from English into multiple target languages:

curl -X POST https://staging.pauhu.eu/translate \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "text": "Each film-coated tablet contains 50 mg of the active substance. Excipients with known effect: each tablet contains 120 mg of lactose monohydrate. For the full list of excipients, see section 6.1.",
    "source": "en",
    "target": "de",
    "domain": "pharmaceutical",
    "formality": "formal"
  }'

Response:

{
  "translated_text": "Jede Filmtablette enth\u00e4lt 50 mg des Wirkstoffs. Sonstiger Bestandteil mit bekannter Wirkung: Jede Tablette enth\u00e4lt 120 mg Lactose-Monohydrat. Die vollst\u00e4ndige Auflistung der sonstigen Bestandteile siehe Abschnitt 6.1.",
  "source_lang": "en",
  "target_lang": "de",
  "confidence": 0.96,
  "terminology_applied": [
    {"source": "active substance", "target": "Wirkstoff", "origin": "IATE"},
    {"source": "excipients", "target": "sonstige Bestandteile", "origin": "IATE"},
    {"source": "film-coated tablet", "target": "Filmtablette", "origin": "IATE"},
    {"source": "lactose monohydrate", "target": "Lactose-Monohydrat", "origin": "IATE"}
  ],
  "cascade_stages_applied": 8,
  "quality_score": 0.95
}

For batch translation across all required markets:

curl -X POST https://staging.pauhu.eu/batch \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "texts": [
      "Each film-coated tablet contains 50 mg of the active substance.",
      "Excipients with known effect: each tablet contains 120 mg of lactose monohydrate.",
      "For the full list of excipients, see section 6.1."
    ],
    "source": "en",
    "targets": ["de", "fr", "es", "it", "pt", "nl", "pl", "cs"],
    "domain": "pharmaceutical",
    "formality": "formal"
  }'

This translates 3 segments into 8 languages (24 translations) in a single API call, with IATE terminology enforced consistently across all target languages.

5 Look up pharmaceutical terminology

Look up key pharmaceutical terms across languages:

curl "https://staging.pauhu.eu/lookup?term=excipient&lang=de" \
  -H "Authorization: Bearer pk_..."

Essential pharmaceutical terminology for the variation dossier:

6 Track CURIA rulings on market authorisation

Search CURIA for relevant case law:

curl -X POST https://staging.pauhu.eu/search \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "query": "marketing authorisation variation excipient pharmaceutical",
    "sources": ["curia"],
    "lang": "en",
    "limit": 5
  }'

CURIA results include case numbers, the chamber, and whether the ruling is preliminary or final:

{
  "results": [
    {
      "case_number": "C-527/07",
      "title": "Generics (UK) Ltd v Licensing Authority",
      "source": "CURIA",
      "ruling_type": "preliminary_ruling",
      "chamber": "Grand Chamber",
      "date": "2009-11-03",
      "topics": ["marketing authorisation", "data exclusivity", "pharmaceutical regulation"],
      "relevance": 0.82,
      "celex": "62007CJ0527"
    }
  ]
}

CELEX numbers for CURIA cases use Sector 6: 62007CJ0527 means a 2007 Court of Justice judgment, case 527. Cross-references link the ruling to the regulations it interprets.

7 Set up a pharma monitoring recipe

Create a recipe for pharmaceutical regulatory monitoring:

curl -X POST https://staging.pauhu.eu/recipes \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "name": "Pharma Regulatory Intelligence",
    "sources": ["eurlex", "ema", "echa", "curia", "commission"],
    "topics": [
      "pharmaceutical regulation",
      "marketing authorisation",
      "chemical safety",
      "pharmacovigilance",
      "clinical trials"
    ],
    "languages": ["en", "de", "fr"],
    "alert_method": "webhook",
    "webhook_url": "https://regaffairs.example.com/pauhu-alerts",
    "frequency": "daily"
  }'

This recipe monitors:

• EUR-Lex: New regulations, directives, and delegated acts on pharmaceutical law
• EMA: Updated guidelines, committee opinions, safety referrals, and PRAC recommendations
• ECHA: SVHC candidate list additions, authorisation decisions, and restriction proposals
• CURIA: Preliminary rulings and judgments on data exclusivity, parallel imports, and MA scope
• Commission: Implementing acts, delegated acts, and legislative proposals

8 Chat with your results

Send a question together with context from your earlier results:

curl -X POST https://staging.pauhu.ai/v1/chat \
  -H "Authorization: Bearer pk_..." \
  -H "Content-Type: application/json" \
  -d '{
    "message": "Is the new excipient subject to REACH authorisation based on its SVHC status?",
    "context": [
      {"source": "ECHA", "title": "Titanium dioxide (TiO2) \u2014 substance evaluation", "ec_number": "236-675-5", "svhc_status": "candidate_list"},
      {"celex": "32006R1907", "title": "REACH Regulation", "articles": ["57", "59"]},
      {"source": "EMA", "title": "Classification guideline \u2014 categories of variations", "reference": "EMA/CAT/C/1223/2008"}
    ],
    "domain": "pharmaceutical",
    "lang": "en"
  }'

Example response (grounded in the retrieved documents):

{
  "response": "Based on the ECHA substance evaluation, titanium dioxide (EC 236-675-5, CAS 13463-67-7) is on the SVHC candidate list as a suspected carcinogen via the inhalation route (added 2022-01-14). Under REACH Article 57, substances meeting the criteria in Article 57(a)\u2013(f) can be identified as SVHCs. However, inclusion on the candidate list under Article 59 does not itself require authorisation \u2014 that obligation arises only when the substance is added to Annex XIV (the Authorisation List). Titanium dioxide is currently on the candidate list but NOT on Annex XIV, so REACH authorisation is not yet required. The EMA variation guideline (EMA/CAT/C/1223/2008) classifies this excipient change as Type II (B.II.a.3(b)), which requires a quality dossier update that should proactively address the SVHC status and any risk mitigation measures.",
  "sources_cited": ["32006R1907 Art. 57", "32006R1907 Art. 59", "ECHA candidate list", "EMA/CAT/C/1223/2008"],
  "model": "SmolLM-135M",
  "grounded": true,
  "confidence": 0.91
}

The response cites Article 57 of REACH, the SVHC candidate list status, and the EMA variation guideline. It distinguishes between candidate list inclusion and the Annex XIV authorisation requirement — a critical distinction for the regulatory affairs team. When the Domain 12 (Law) specialist model ships, the same endpoint automatically uses it for better accuracy.

Next steps

For the variation dossier

With the data collected above, the regulatory affairs manager can now:

1. Classify the variation: Type II (B.II.a.3(b)) per Regulation 1234/2008 — excipient replacement with a different substance
2. Check substance compliance: Verify the new excipient is not on the ECHA SVHC candidate list or authorisation list
3. Prepare translations: SmPC, package leaflet, and labelling in all authorised languages, using IATE-enforced terminology
4. Review case law: Confirm no CURIA rulings affect the interpretation of the variation classification
5. Set up monitoring: Recipe configured to alert on EMA guideline updates, ECHA substance additions, and relevant EUR-Lex publications
6. Chat answers: Follow-up questions answered by grounded chat, citing REACH articles, SVHC status, and EMA variation guidelines

Related demos

• Demo: Government Procurement Compliance — EUR-Lex search, Finnish translation, TED notices, national transposition

Further reading

• Search Guide — full query syntax, filters, and boolean operators
• Translation Guide — 24 languages, batch translation, formality levels
• IATE API Reference — all 11 terminology endpoints
• Recipe Catalog — 6 pre-configured monitoring recipes
• Full API Reference — all endpoints, authentication, rate limits

Questions?

Contact support@pauhu.eu or your Pauhu account manager.