January 11, 2018

Ministry has decided to move away from the requirement of submitting signed contracts with investigators and sites. It will be not mandatory to submit signed contracts between Sponsor and sites what will cause in faster completing of documentation, submitting and appli...

August 7, 2017

The new regulation will bring harmonization of procedures what will cause the Poland to be in the top ten countries in terms of receiving applications for clinical trials. These predictions are due to the demography of Poland, but in order to make our country look even...

July 13, 2017

The subject of non-commercial trials are drugs already marketed and it is not intended to investigate and introduce new innovative products but to analyze the efficacy of different doses of medication in different indications (eg. pediatric). This approach allows to br...

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).

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