Clinical trials and applicable Polish law

Laboratory research in science and medical setting.

Fast development of health sector in Poland provides the opportunities to use the results of medical research. The most significant effect can be visible on the example of clinical trials, which are being increasingly more often conducted in Poland (over 40 thousands of patients in Poland take part in clinical trials almost every year). The clinical trials verify the effectiveness and the safety of new medicinal products, taking into account, among others, ethic rules resulting from Good Clinical Practice, WMA Declaration of Helsinki, Regulation (EU) No 536/2014, Polish Pharmaceutical Law or Polish Medical Profession Act. The text focuses on legal regulations applicable to the Polish market of clinical trials and discusses the advantages that the Polish market offers for clinical trials, also involving foreign investors.


See the link to the article in Polish:,Prawo-badan-klinicznych-w-Polsce.html 


The information was prepared by Anna Bednarska of KG Legal Polish Law Firm. KG Legal provides specialised legal assistance to IT, Life Science as well as investment processes in Poland and organises networking between Polish and international companies and research centres.

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