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Web-scraped EMA guidelines and European Public Assessment Reports

SND-ID: 2023-254. Version: 1. DOI: https://doi.org/10.57804/wa37-j878

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epars_metadata.csv (276.82 KB)

epars.zip (62.97 MB)

guidelines_metadata.csv (158.72 KB)

guidelines.zip (7.47 MB)

piecewise_method_code_231122.py (8.01 KB)

Associated documentation

readme 231122.txt (2.3 KB)

Download all files

2023-254-1.zip (~70.88 MB)

Citation

Creator/Principal investigator(s)

Gabriel Westman - Uppsala University, Department of Medical Sciences

Research principal

Uppsala University

Description

This submission consists of the data and python code that supports the original research article "A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model" (Bergman et al, PLOS ONE 2023).

The database contains metadata and fulltext from 669 EMA Scientific guidelines and 1024 EMA European Public Assessment Reports.

Data contains personal data

Yes

Type of personal data

Authorship of assessments and studies

Language

Method and outcome

Unit of analysis

Media unit: Text

Population

Open regulatory data on medicinal products

Study design

Observational study

Sampling procedure

Total universe/Complete enumeration

All EMA guidelines and European Public Assessment Reports (EPARs) from the time period specified.

Time period(s) investigated

2008-01-01 – 2022-12-31

Number of individuals/objects

1693

Data format / data structure

Data collection

Geographic coverage

Geographic spread

Geographic location: European Union (EU)

Administrative information

Topic and keywords

Research area

Basic medicine (Standard för svensk indelning av forskningsämnen 2011)

Keywords

Drug therapy, Computer linguistics, Semantic analysis

Publications

Published: 2023-11-27