Waivers and Paediatric investigation plans (PIPs; in red if notified to have been discontinued; including their modifications). Regular expressions can be used, e.g. ^(?!.*diabetes).*$ to filter out diabetes. While re-ordering a column, do not use a filter in it.

This plot is produced if 150 or fewer PIPs are filtered in 'List'. The following events are shown with dates (only last event shown if date are the same). S is the submission leading to the first decision. Numbers indicate the planned completion of the initially agreed PIP (0) or its modifications (1 or higher). C is a compliance opinion. X indicates that discontinuation was notified. The blue vertical line indicates today.

These figures summarise the development across all studies, based on the latest decision. These figures are produced only if 100 or fewer PIPs are filtered in ‘List’.

The tables includes the available descriptions of the studies in agreed PIPs, from which the age ranges are calculated. These details are produced only if 100 or fewer PIPs are filtered in ‘List’.

This page shows the time lines of progress with Paediatric Investigation Plans (PIPs). The lines show the initially agreed timeslines (dashed) and the actual timelines (solid) for those PIPs that are completed (left panel, defined as having a compliance opinion and not having been notified as discontinued) or that are not yet completed (right panel, defined as not having a compliance opinion and not having been notified as discontinued). Counts of subsets of PIPs are on the Summary tab page.

Note: The initially agreed timelines could not be extracted and therefore are missing for some PIPs. To accomodate this issue, the plots do not show the counts but rather the density of PIPs over time.

Completed PIPs

PIPs without compliance opinion, not notified to be discontinued

This page presents a summary of the data set available in this webapp. Please see About tab for how the webapp is updated and filled.

Click and copy the URL as a permanent bookmark of the current state of the app (search, filters, column visibility).

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Contents

This webapp shows information that was automatically extracted from decisions made publicly available by the European Medicines Agency (EMA) on their website. Current EMA Decisions can be found under this link. Previous decisions that can be found in the EMA website are also included in this webapp.

Credits and disclaimer

The European Medicines Agency (EMA) is acknowledged as a source 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. Extraction of information from PDF files is error-prone, and the information should be used cautiously. Users have the responsibility to verify the information they use.

Author and citation

Data in webapp

  • added PIP and waiver decisions
  • added discontinuations
  • added compliance opinions

Webapp

  • 2018-01-07 initial release
  • 2018-07-07 show applicant
  • 2018-07-11 show studies by modification
  • 2018-08-12 added summary and completion tabs
  • 2018-08-15 added access to decision files
  • 2018-09-09 divided by condition, column selection
  • 2018-11-01 adapted to revised source website
  • 2018-11-25 revised into Shiny app
  • 2019-06-06 improved extracting PDF contents
  • 2019-06-29 improved user interface
  • 2019-12-07 improved discontinuation date detection