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 if dates 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 150 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 150 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 and the latest timelines for those PIPs that are completed (left panel, defined as having a compliance opinion and not notified as discontinued) or that are not yet completed (right panel, defined as not having a compliance opinion and not notified as discontinued, based on latest PIP modification). Counts of subsets of PIPs are on the Summary tab page.

Note: For some PIPs, the initially agreed timelines could not be extracted and are therefore missing. To accomodate this issue, the plots do not show the counts but rather the density of PIPs over time. Moreover, compliance opinions may not yet have been made public, see Summary tab page, which at the moment leads to a plateau artefact for the line 'Actual completion' for the year 2021 in the left plot.

Completed PIPs

PIPs without compliance opinion, not 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, and for the disclaimer including on possibly incorrect information.

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

Click to remove filters and searches, and to restore the default column visibility.

Contents

This webapp shows information that is 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 were found over time in the EMA website are also included in this webapp. In addition, information from PIP compliance opinions and from notifications of PIP discontinuations are included. All these contents are checked at the source and updates are included on a daily basis.

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

Comments are welcome in the blog here.

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
  • 2020-04-26 updated to EMA website changes
  • 2021-05-30 harmonised PIP completion plots
  • 2021-06-11 better aligning conditions and indications
  • 2022-10-01 faster webapp start
  • 2023-05-13 system update
  • 2023-07-13 mitigate PDF metadata errors
  • 2023-12-10 updated to new EMA website
  • 2024-03-28 accommodated source XLS file outdated on EMA website