As of 31 January 2025, the transitional period for applying previous national clinical trial regulations under the Pharmaceutical Law Act will end. From that date onwards, new rules introduced under the Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use will apply.
Key changes include:
- Alignment with EU Regulation No. 536/2014:The new Act implements the provisions of Regulation (EU) No. 536/2014 of the European Parliament and of the Council, harmonizing procedures related to the conduct of clinical trials within the European Union.Ustawa z dnia 9 marca 2023 r. o badaniach klinicznych produktów leczniczych stosowanych u ludzi – Journal of Laws 2023, item 605
- Mandatory Registration in CTIS:Starting from 31 January 2025, all clinical trials conducted in Poland must be registered in the Clinical Trials Information System (CTIS). Trials previously approved under Directive 2001/20/EC, which are still ongoing, must be transitioned and registered in CTIS in compliance with the Regulation. Failure to comply with this obligation may result in such trials being considered non-compliant with the law.
Detailed guidance on the transfer process for trials approved under Directive 2001/20/EC to CTIS is available on the EMA website: https://health.
3. Update of Documentation Related to Personal Data ProcessingIn accordance with Article 90(1) and (2) of the Act of 9 March 2023, by 31 January 2025 it is required to update all documentation related to the processing of personal data, including data concerning clinical trial participants. This update aims to ensure compliance with the new legal requirements regarding data protection.
The implementation of these changes is intended to enhance the safety of clinical trial participants and to harmonize research processes across the European Union.