powell
☆    

China,
2020-02-10 06:36
(1526 d 07:17 ago)

Posting: # 21156
Views: 2,145
 

 clinicaltrials registration [Regulatives / Guidelines]

Hi, shold Bioequivalence studies be registered on clinicaltrials website in EU?
Dr_Dan
★★  

Germany,
2020-02-11 17:03
(1524 d 20:50 ago)

@ powell
Posting: # 21158
Views: 1,496
 

 clinicaltrials registration

Hi
The European Union Clinical Trials Register is intended for protocols and results information on:
a) interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
b) clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
There is no need to register bioequivalence studies that are conducted outside EU and EEA.
I hope this helps.

Kind regards and have a nice day
Dr_Dan
powell
☆    

China,
2020-02-13 11:00
(1523 d 02:53 ago)

@ Dr_Dan
Posting: # 21170
Views: 1,429
 

 clinicaltrials registration

Thank you Dr Dan!


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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