The Law on Clinical Trials of Medicinal Products for Human Use has been signed by the President and published in the Official Gazette.
The law's provisions will take effect on April 14. On that day, a Clinical Trials Compensation Fund will be established at the Patient Ombudsman. This is an innovative solution expected by patients and the clinical research industry. The Ombudsman will also maintain a publicly accessible list of patient organizations.
The law increases the attractiveness of conducting clinical trials in Poland and ensures a high level of care for the rights and interests of participants in these trials. The solutions introduced include:
- Establishment of the Supreme Bioethics Commission,
- A new fee system for conducting scientific and ethical assessments of a research registration application,
- separa...
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