EBA advocates optimizing approval of orders for conducting clinical studies
The European Business Association (EBA) notes a systematic violation of the deadlines in the adoption of orders by the Health Ministry of Ukraine on the approval of clinical studies, insists on the need to optimize the process.
According to the appeal of the association to Prime Minister of Ukraine Volodymyr Groysman and Acting Minister of Health Ulana Suprun, published on the EBA's website, this situation has been observed for three years.
The report notes that the actual deadline for approval by the Ministry of Health of the corresponding order on research is three or six times more than the period established by the procedure for clinical trials of medicines.
International companies supplying drugs for clinical trials cannot start their implementation on time, which affects the image of Ukraine as a country for conducting clinical research activities, the association noted.
The EBA proposed to introduce e-sighting of research orders, envisage the possibility of signing them by the deputy minister, and also ensure their timely publication.