Who Will Get Subsidies for CT Conduct?
The Ministry of Industry and Trade of the Russian Federation has developed a draft of government decree “On making amendments to principles of provision of subsidies from the federal budget to Russian enterprises for partial reimbursement for projects on organization and conduct of clinical studies of drugs within the subprogram “Development of Manufacture of Drugs” of the State program of the Russian Federation “Development of Pharmaceutical and Medical Industry in 2013 – 2020”.
According to the document it is suggested to extend the list of priority areas of scientific research in the field of innovative development of healthcare. It is suggested to introduce areas of development of drugs for early detection and treatment of gastrointestinal and metabolic, hematological, oncohematological and congenital hereditary disorders, for early detection and treatment of respiratory tract disorders and treatment of orphan diseases. It is suggested to include into the priority list the development of drugs used in transplantology and treatment of pain syndrome.
The project of decree suggests to increase the maximum time of launching of the drug being developed in the market from 3 to 4 years, to ensure support of projects involving long-term clinical trials.
The draft of decree admits sponsorship of projects on drugs if the state register of drugs for medical use contains information on not more than two authorized Russian drugs of different manufacturers under equivalent international non-proprietary name (or the corresponding chemical or group name), pharmaceutical form and indications for use.
It is also suggested to increase the maximum amount of subsidy from 200 to 400 mln rubles for all contracts signed with the Russian enterprise according to the Rules.
Public discussion of the project will be held until March 5, 2016.