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 was which applied before the implementation of Directive 2001/20/EC
All requests by product groups
Decisions on clinical trial applications
(August 2004 - 2020)
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|
|Subst. Amendments (requiring authorisation)|
Distribution of decisions
|0,50%||approval with conditions|
|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 12/2020.
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.