The Ministry of health of Russia has developed amendments to articles 13 and 15 of the Federal law “On circulation of medicines”, which are directed on improvement of procedure of the scientific advice in the sphere of circulation of medicines.
The need to clarify this procedure arose due to lack of demand for counselling because, in accordance with the current edition of the Federal law 61-FZ, the power to exercise counseling vested in the Federal state budgetary institution subordinated to the Ministry of health and are not involved in the organization of carrying out examination of medicines in their registration and, consequently, not possessing the special scientific and practical resources in this area.
The bill proposes to empower the Federal state-financed institution carrying out expert examination of medicinal products with authority to administer counseling drug developers on issues of preclinical and clinical trials of drugs, assessment of their quality, effectiveness and safety and registration of medicines at the expense of the applicant.
Also, the bill provides for the approval by the authorized Federal body of Executive power of the exercise of the expert institution counseling of the subjects of circulation of medicines.
Public discussion of the bill is on the website regulation.gov.ru until 15 August.