Information for units requesting authorisation to conduct clinical trials

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05.04.2022
To the attention of medical units intending to participate in interventional clinical trials with medicinal products for human use
In line with Emergency Government Ordinance no. 29/2022, the ANMDMR will only authorise medical units intending to participate in phase I or bioequivalence clinical trials with medicinal products for human use.
The authorisations regarding the sites of clinical trials for medicinal products for human use, issued prior to entry into force of this emergency ordinance, remain valid until 31 January 2025.
For medical units intending to conduct interventional clinical trials with medicinal products for human use, with therapeutic benefit, no authorisation for conducting clinical trials will be issued, in line with Scientific Council Decision no. 2/2014.
Regarding the documentation required to support investigation centers/investigators which will have to be included in the application files for new clinical trials, submitted both under Directive 20/2001 on clinical trials and Regulation 536/2014, the forms published on the EC website, Eudralex vol. 10 (Part II application document templates) will be used, until publication of the detailed rules referred to in Art. 3 of Emergency Government Ordinance no. 29/2022.