July 13, 2017

Clinical Trial Application | All Member States will have to follow the same rules and time requirements when evaluating CTA. CTA will be submitted by EU portal and sponsor shall propose one of the Member States concerned (MSC) as reporting Member State (RMS).

June 19, 2017

EMA, FDA and PMDA held a second tripartite meeting in Vienna on 26-27 April 2017. The main topic were regulatory approaches for the evaluation of antiobacterial agents and differences of data requirements.

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