Compassionate Drug Use – Time Arising for a New Law in Bulgaria in the Era of COVID-19

Nigyar Dzhafer, Jannis V. Papathanasiou
2020 Folia Medica  
Nowadays the health care systems over the world are in a critical period trying to take control over the pandemic of COVID-19. The Bulgarian the Government introduced rapidly (8-to March 2020), restrictive control measures including general lockdown and social distancing. Despite several clinical trials, there are still no specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use (CU). The global pandemic mandates
more » ... c mandates Bulgarian Drug Agency (BDA) for a reasonable update of the existing national regulation concerning CU and off-label therapies. The update of the existing national regulation regarding CU is vital to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond.
doi:10.3897/folmed.62.e53742 pmid:33009760 fatcat:rt45bw5rh5anvo277n6ujyar7a