Bioequivalence and Bioavailability Forum

powell ☆ China, 2020-02-10 06:36 (1967 d 21:42 ago) Posting: # 21156 Views: 3,213	clinicaltrials registration [Regulatives / Guidelines] Post reply
	Hi, shold Bioequivalence studies be registered on clinicaltrials website in EU?

Dr_Dan
★★

Germany,
2020-02-11 17:03
(1966 d 11:15 ago)

@ powell
Posting: # 21158
Views: 2,366

clinicaltrials registration

Post reply

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 (1964 d 17:19 ago) @ Dr_Dan Posting: # 21170 Views: 2,290	clinicaltrials registration Post reply
	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]

clinicaltrials registration [Regulatives / Guidelines]

clinicaltrials registration

clinicaltrials registration