Poland: New draft act on clinical trials of human use medicinal products

In brief

On the beginning of May we sent a newsletter regarding the draft act on clinical trials of medicinal for human use that implements the Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC ("Regulation").

On 17 January the new version has been published in a public domain ("Draft").


General comments

First of all, the Draft is still on an early stage of the legislation process, thus it will not come in force by 31 January 2022, when the Regulation comes in force. The Draft assumes to come in force within 30 days as of the date of its publication.

The most important changes introduced in the current version of the draft regard:

  • the timelines for ethical review - this section has been completely modified as compared to the initial version;
  • creation of the Clinical Trials Compensation Fund at the disposal of Patients Ombudsman in place of Clinical Trial Participant Protection Fund at the disposal of the President of Medical Research Agency, along with reduction in the maximum amounts of compensation benefits for bodily injury, health disorder or death;
  • introduction of the "compassionate use" procedure into the Polish legal system.

Click here to access the full alert.

Polish version

Contact Information
Vanina Caniza
Buenos Aires
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Juliusz Krzyżanowski
Senior Associate
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