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EMA provider

The European Medicines Agency (EMA) provider contributes human-medicine regulatory indications. Mira reads the EMA medicines report and creates regulatory Clinical Reports from its therapeutic areas and indication text.

See EMA human medicines for the workbook, worksheet, expected columns, and local file path.

What EMA contributes

Every EMA report has these values:

Clinical Report field Value
provider EMA
source EMA Human Drugs
origin REGULATORY_AGENCY
type INDICATION
id Lowercase EMA product number.
url Medicine URL supplied in the workbook.

The workbook's medicine status becomes phaseFromSource and is mapped to Mira's shared clinical-stage categories. For example, authorised becomes APPROVAL, while withdrawn, suspended, lapsed, or other statuses retain their corresponding meaning. The marketing-authorisation year is retained when its date can be parsed.

Selection and label rules

Mira keeps workbook rows whose Category is Human. It chooses drug labels in this order:

  1. international non-proprietary or common name;
  2. active substance;
  3. medicine name.

Note

For diseases, Mira prefers the supplied Therapeutic area (MeSH). When that field is missing, disease named-entity recognition (NER) extracts disease mentions from Therapeutic indication.

Semicolon-separated drug and disease values are split into separate labels. Rows are excluded when no drug label or no disease label remains after this processing. Duplicate report rows are removed.

Mapping behavior

EMA supplies descriptive drug and disease labels rather than the ChEMBL and EFO identifiers required by the Open Targets output. Disease NER identifies mentions; it does not perform ontology mapping. The shared entity-mapping stage assigns identifiers after EMA reports have been combined with the other providers.

Implementation reference