EPARs - European public assessment reports

Background

The webapp shows information that is automatically extracted at least once a week from information made publicly available by the EMA, European Public Assessment Reports (European Medicines Agency 2012). The purpose is to tabulate information and make it more readily searchable. The webapp covers the Summary of Product Characteristics, post-authorisation studies and the assessment reports (fulltext). The webapp takes a few seconds to fully load. See the “About” tab for how to credit the EMA and for how to cite the webapp.

References

This webapp has been used for unpublished work and for:

Klinglmueller F et al. A Review of EMA Public Assessment Reports Where Non-Proportional Hazards Were Identified. arXiv 2024, https://doi.org/10.48550/arXiv.2406.12492
Hooker A et al. (CONFIRMS consortium) Uncertainty quantification methods for complex models used in drug development and/or regulatory approval. 2025, event

Webapp

Maximise

Changes

2025-11-06 improved assessment analysis (thanks for the suggestion), bookmarkable
2025-10-26 preparing major change in update mechanism
2025-10-25 may not be able to update more often than once weekly
2025-10-12 removed adapting to old bookmarks, please bookmark newly
2025-08-08 improve daily ingest and post-authorisation digestion
2025-07-31 add advanced therapy column, correct MeSH mangling
2025-07-26 expand daily data updates
2025-05-11 disable http/2 when retrieving documents from source
2025-04-28 improve restoring old bookmarks
2025-04-21 addressing issues to obtain all source documents
2025-03-30 catering for more than one post-authorisation steps document
2024-08-14 adding querying from URL query string (see https://paediatricdata.eu/emapips/)
2024-05-04 adding document-level assessment analysis (thanks for the suggestion)
2024-03-28 accommodated source XLS file outdated on EMA website
2023-12-10 update to changed EMA website
2023-07-30 correct post-authorisation extraction, improve guessing paediatric indication
2022-10-09 small changes to assessment analysis query syntax (after replacing Lucene with SQLite)
2022-10-08 re-introduced text search in images of SmPCs and assessment reports
2022-10-01 updated paediatric indication algorithm; faster webapp start
2021-10-24 steps after authorisation now finds most assessment reports
2021-10-03 new: steps after authorisation (further functions in the works)
2021-09-14 correct MeSH root term finding
2021-05-17 correct indexing PDF files (tab “Assessment analysis”)
2021-05-04 start OCRing images in PDF files (- 2021-09-25 temporarily disabled)
2021-05-04 delete remnants renamed products
2021-04-22 fix when several SmPCs are found for one product
2020-09-26 state now authorised, withdrawn, suspended, refused
2020-09-09 adding fulltext assessment report query
2020-05-17 improved paediatric indication detection
2020-05-10 fix indication extraction
2020-03-14 speed up
2020-02-20 only show indications from SmPC PDF
2019-12-03 enable regex filtering on empty columns
2019-11-17 adding calculating paediatric indication (in testing; uses section 4.1 information)
2019-09-14 adding imposed post-authorisation studies
2019-08-31 more indications from PDF, MeSH
2019-06-21 improve user interface functions and bookmarking
2019-06-11 generate MeSH trees and root terms for each medicine (see new column)
2018-10-31 initial release

References

European Medicines Agency. 2012. “European Public Assessment Reports: Background and Context.” https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when/european-public-assessment-reports-background-context.