Overview
This page provides an overview to the data sets and information made publicly availalbe by medicine regulatory agencies. At this time, it includes references to only the EMA. The webapp below is for finding data related to
documents
DHPCs (dear health care professional communications)
medicine shortages in the EU
scientific guidelines
medicines used outside the EU
periodic safety update single assessments
post-authorisation referrals
orphan designations
paediatric investigation plans
The content of source(s) of data of interest can be accessed here as follows.
| Source at EMA | Type of data | This site provides | Access here to | |
|---|---|---|---|---|
| Novel methodologies | Link | PDF files (Submission, letter of support, opinion) | Webapp | Structured project information1 |
| Paediatric investigation plans (including waivers) | Link | PDF files (Decisions, Opinions) | Webapp2 | PDF files content (English only) searchable and structured |
| Orphan designation | Link | PDF files (Summary of opinion), structured product webpage | None | None |
| Clinical trials | Link | Structured webpage, PDF files (i.a., protocol, reports, SIS, ICF) | R package | Content via scripting |
| Medicine assessments (Human use, centrally authorised) | Link | PDF files (assessment reports, variation reports, risk management system), structured product webpage | Webapp | PDF files content (English only) searchable and structured |
| Clinical data publication3 | Link | PDF files (Clinical study reports, CSRs, Overviews, Summaries, Anonymisation reports) | None | Under consideration |