Hi,

We would like to register one of our drugs in European Union. Clinical trial, BE, BA study is necessary of this registration? are they conduct GMP audit? I will be grateful if anybody can let me know the process involved in drug registration.

Usha

Does anyone have something to offer for Cinti?

Hi,

We would like to register one of our drugs in European Union. Clinical trial, BE, BA study is necessary of this registration? are they conduct GMP audit? I will be grateful if anybody can let me know the process involved in drug registration.

Usha

I don't know much about it but the organisation that deals with it is called the European Medicines Agency (EMEA) http://www.emea.europa.eu/

You should be able to find some info on their website. I think once it is approved by them it also has to get approved by the agencies per-country as well, but I'm not very sure.

Regards
T.