On 23 March 2020, the Romanian Department for Emergency Situations (DSU) issued Order No. 74527/2020, which implements measures to limit the spread of the coronavirus at healthcare units.
This Order was passed after more and more hospitals in Romania reported the spread of the coronavirus among patients who were being treated for other diseases and among healthcare professionals.
According to this Order, all hospital admissions that are not urgent and can be re-scheduled and all related consultations in private and public healthcare units are suspended for a period of 14 days beginning 24 March 2020. Also, all hospital patients who are not emergency cases and do not require hospitalised treatment must be discharged within 48 hours.
These measures also apply to ongoing clinical trials and the scheduling of patients enrolled in clinical trials as per the approved protocols. The Romanian National Agency for Medicines and Medical Devices (ANMDM) issued the following recommendations for companies conducting clinical trials in the aftermath of Order No 74527/2020:
– study visits should be rescheduled or conducted by telephone;
– trial medications should be sent to the homes of the study patients; and
– remote monitoring should be implemented.
At the European level, the European Medicines Agency (EMA) and national Head of Medicines Agencies published a guidance on the European Commission’s website with recommendations on clinical trials in the current situation. The new recommendations are available here).