Paul-Ehrlich-Institut

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

Overview of all requests (August 2004-12/2020) (Source: Paul-Ehrlich-Institut)

Distribution of clinical trial authorisations by commercial and non-commercial sponsors

Distribution of Clinical Trial Authorisations by commerical and non-commercial sponsors in percent (Source: Paul-Ehrlich-Institut)

* Without clinical trials for was which applied before the implementation of Directive 2001/20/EC

All requests by product groups

All requests by product groups 8/2004-12/2020 (Source: Paul-Ehrlich-Institut)

All requests by product groups 8/2004-12/2020 in % (Source: Paul-Ehrlich-Institut)

Decisions on clinical trial applications

(August 2004 - 2020)

All requests by decisions (Source: Paul-Ehrlich-Institut)

All requests by decisions in % (Source: Paul-Ehrlich-Institut)

Protest procedures may alter the outcome of the procedure in retrospect compared with the data of the previous year.

Amendments to clinical trial authorisations

Amendments to clinical trial authorisations (August 2004 - 12/2020) (Source: Paul-Ehrlich-Institut)

Type of requestPortionType of notification
Notifications100%favourable
Subst. Amendments (requiring authorisation)
Distribution of decisions
0,20%pending
96,50%approvals
0,50%approval with conditions
1,40%partial Rejection
0,45%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 12/2020.

Submission of Annual safety reports to the PEI

Submission and Annual safety reports to the PEI (Source: Paul-Ehrlich-Institut)

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: 12.01.2021