Prior to conducting a
clinical trial in Russia, the sponsor must submit all relevant documentation,
including the clinical trial protocol, to the Ministry of Health.
The documents will then be forwarded to the Pharmacological Committee
and to the National Ethics Committee for approval. The approval process
takes about 60 days.
In order to import the study drug, shipment approval must also be
obtained from the Ministry of Health. This takes two to three weeks
on average.
The Russian GCP guidelines are based on ICH GCP and have been integrated
into the national regulations.
 Health
Care System |
The number of international
clinical trials conducted in Russia is increasing steadily.
A considerable proportion of the patients are treatment-naive.
In Russia there is universal access to free outpatient and inpatient health care services. A basic medical care package is provided free of charge. Further medical services beyond this minimum package are provided on a fee basis. For this reason many people now have voluntary health insurance (usually financed by employers).
There is a network of local polyclinics in which general practice physicians and specialists provide ambulatory services. Patients are assigned to a state polyclinic according to their residential district. There is a high doctor-to-patient ratio.
State-owned hospitals provide inpatient services. Many of these hospitals are specialised and very large. For admission to a hospital it is necessary to have a referral of a polyclinic physician/specialist.
Private health care is slowly starting to develop, particularly in major cities. At present, only few private clinics exist. |
|
RUSSIA
