Collected from webpages of the EMA and FDA. Note that columns 'issuedSupport' and 'issuedQualification' may have been calculated in this webapp; FALSE indicates that so far these have not yet been issued. Negative opinions issued after an evaluation or refusals are not available for all sources in this webapp.

Summary

Contents

This webapp shows information that is extracted from web pages made publicly available by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on their websites. The information in this webapp is updated automatically and at least once weekly.

Tools that resulted from pre-competitive research in public-private partnerships (consortia) funded by the European Union can be found in this searchable catalogue of the Innovative Medicines Initiative (IMI).

Results in the EU-funding policy area of Public Health can be found here in the Horizon Results Platform.

Credits and disclaimer

The EMA and the FDA are acknowledged as sources of information used in this webapp and should always be acknowledged by users. Consult the European Medicines Agency copyright and limited reproduction notices here.

The correctness of information shown in this webapp is not verified and the information is not guaranteed to be correct. Users have the responsibility to verify the information they use.

Author and citation

For further information, see this blog post.

Webapp

  • 2026-01-14 expanded links to EMA documents and case section
  • 2025-10-26 mechanism changed to update at least once weekly
  • 2025-10-18 added FDA’s Qualified Medical Device Development Tools (MDDTs)
  • 2025-06-22 added FDA’s CDRH peer-reviewed regulatory science tools catalogue
  • 2025-04-21 implement more robust approach
  • 2025-03-16 added explanations and latest FDA status
  • 2025-01-13 updated to changes on FDA and EMA websites
  • 2024-05-05 updated to changed FDA website
  • 2023-12-07 updated to new EMA website
  • 2023-11-18 add proposers for EMA, complete for FDA
  • 2023-09-23 list all DDT document types
  • 2023-08-20 added FDA’s Fit for purpose outputs
  • 2023-05-13 initial release, covering five different sourceTypes