Clinical trials and compassionate use of medicinal products

CLINICAL TRIALS OF MEDICINAL PRODUCTS

Accepted principles for conducting  clinical trials in humans are based on the protection of human rights and human dignity regarding the use of biology and medicine, as reflected in the text of the Declaration of Helsinki. The protection of clinical trial subjects is ensured by risk assessment based on the results of toxicological tests performed prior to any clinical trial, reviews by medical ethics committees and competent authorities of Member States, as well as on the rules on personal data protection.

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022. The Clinical Trials Regulation foresees a 3-year transition period to CTIS.

Transition period

  • From 31 January 2022 until 31 January 2023, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive (EC) No. 2001/20/EC through national submission processes, or under the Clinical Trials Regulation through CTIS.
  • From 31 January 2023 all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS.
  • From 31 January 2025 trials approved under the Clinical Trials Directive that are still ongoing will have to be transferred to the Clinical Trials Regulation and to CTIS.

Compassionate use

as determined in Article 83 of Decree 726/2004/EC, means provision of a medicinal product with a new active ingredient which represents an important therapeutic, scientific, and technical innovation, and must be undergoing clinical trial or have entered the  centralised marketing-authorisation application process t, whereby it is made available to a group of patients with chronically or seriously debilitating disease which cannot be treated satisfactorily by an authorised medicinal product.

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