ROMANIA: Important Announcement of ANMDMR to the attention of companies conducting clinical trials
UPDATED on March 24th, 2020
National Agency for Medicines and Medical Devices in Romania (ANMDMR) issued an important message to the Sponsors of clinical studies in the country.
Announcement from March 13th, 2020 in the local language can be found here. Below we provide our translation.
In view of the current epidemiological context, it is necessary to take measures to protect the population, including patients/subjects enrolled in clinical trials. In this respect, ANMDMR requires companies conducting clinical trials in Romania:
- to identify the potential impact of general protection measures against the COVID-19 pandemic on the current activities carried out in each clinical trial;
- notify the ANMDMR of the necessary plan of specific measures; they can be considered, on a case-by-case basis, as urgent safety measures with immediate implementation.
March 24th, 2020: The evaluation of clinical studies with drugs for the treatment of COVID-19 infection will be prioritize by ANMDMR (maximum of 7 days is expected). ANMDMR also supports, for this type of studies, the coordinated evaluation at EU level through the VHP procedure; in this case, the timing of the procedure will be established in agreement with the other Member States. The announcement can be found here.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
