Processing Statistics
This section shows the processing statistics on clinical trials for which the Paul-Ehrlich-Institut is the competent authority.
Overview of all requests
Distribution of clinical trial authorisations by commercial and non-commercial sponsors
* Without clinical trials for which was applied before the implementation of Directive 2001/20/EC
All requests by product groups
Decisions on clinical trial applications
(August 2004 - 2021)
Protest procedures may alter the outcome of the procedure in retrospect compared with the data of the previous year.
Amendments to clinical trial authorisations
| Type of request | Portion | Type of notification |
|---|---|---|
| Notifications | 100% | favourable |
| Subst. Amendments (requiring authorisation) Distribution of decisions | 0,30% | pending |
| 96,50% | approvals | |
| 0,50% | approval with conditions | |
| 1,40% | partial Rejection | |
| 0,50% | rejections | |
| 0,90% | withdrawal of Amendment |
The table is representing the figures for amendments to clinical trial requests requiring an authorisation and amendments for notification only from 2004 to 12/2021.
Submission of Annual safety reports to the PEI
An Annual Safety Report has to be submitted to the Paul-Ehrlich-Institut for clinical trials, that are performed in Germany for longer than one Year.
Updated: 02.03.2022
