NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Thursday, I sent an email to PEI (Paul-Ehrlich-Institut) and asked them why those changes are not reflected yet on the German site.
I'm waiting for a reply.

About two weeks ago I asked the PEI (Paul Ehrlich Institut) why the CTA (Clinical Trial Application) that was uploaded by the British NCA (National Competent Authority) was different from the CTA that was uploaded by the German one.

Here is the reply from Dr.Hartmut Krafft,
VHP-Administrator Head, Section Clinical Trials
Paul Ehrlich Institut.

Dear XXXX,

thank you for this interesting questions. The answer is not that easy and far away from being satisfying.

Although EudraCT gives the impression that a clinical trial (CT) is harmonised or identical in the main features between the EU Member States, this is often not the case. Although a clinical trial shows up with one EudraCT number, the content might be different, just as you noticed in EudraCT number 2011-001977-13. None of the Member States has the task, the personnel or the IT means to compare the information of one CT between the Member States, not even between the same CT on the level of the database and especially not on the level of the complete study protocols or other documents . Whether the differences were already in the original submissions of the CT or were introduced upon request of the Competent Authorities during the authorisation process, or were introduced after the approval by substantial amendment is unknown. As a button line: eudract pretends more harmonization than is existing. The new portal on CT will solve this issue (hopefully) beginning in 2022.


Kind regards
H. Krafft

Dr. H. Krafft
VHP-Administrator
Head, Section Clinical Trials
Paul Ehrlich Institut
Paul-Ehrlich-Str. 51-59
D-63225 LANGEN
Germany
Tel. [phone]
Fax [phone]