The Current Climate of Clinical Trials in Russia and Ukraine | Page 8
Application Requirements
As in other countries, the first important consideration
is to submit a complete package to avoid multiple
reviews and/or rejection.
As of July 1, 2015, the total typical time for approval
is 40 days. There is an initial review occurring within
five working days to determine if there is sufficient
information, a full review within 30 working days and
a review of the conclusions and decision within five
working days.
Currently, there are approximately 1,160 institutions in
Russia accredited by the MoH (registry database can be
found at http://grls.rosminzdrav.ru/Ree_orgCI2.aspx),
and accreditation can be provided for the
following reasons:
ESTABLISH DRUGS ARE SAFE AND/
OR TOLERABLE FOR HEALTHY
VOLUNTEERS
SELECT OPTIMUM DOSES AND
TREATMENT COURSE
A clinical trial’s application requires
the following*:
ESTABLISH SAFETY AND EFFICACY
FOR SPECIFIC DISEASES
Principal investigator must have
at least three years experience in
clinical trials
EXPAND INDICATIONS AND IDENTIFY
THE UNKNOWN SIDE EFFECTS OF
EXISTING DRUGS
Medical institution must be
accredited by the MoH to conduct
clinical trials of pharmaceutical drugs
for medical uses26
Ethics review required at two levels
(can be a simultaneous review)
• Central (national) ethics committee
at the MoH
• Local ethics committee in the
institution (fee might be required)
*Application must be in Russian and cannot
be in English
The responsibility for accreditation is with the
institution, which is required to have a license for
medical activities, availability of intensive care and
resuscitation wards or departments and copies of the
regulatory legal act. The institution is also required
to comply with approved rules of clinical practice
and protect confidential information. The review of
the accreditation requirements reportedly occurs
within five days after submitting the package, and the
accreditation lasts for five years.
‘‘
As of July 1, 2015, the total typical
time for approval is 40 days.
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