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LABMGMU — commercial organization that specializes in organization and conduct of clinical and preclinical trials of medicines and dietary supplements.

Carefully and responsible approach, highly qualified employees, deep theoretical knowledge and extensive experience allow to carry out research of any degree of complexity.

Last News

A Wider Circle!

Issues of regulating the circulation of biomedical cell-based products (BCP) were discussed at the meeting of the Duma Subcommittee on production and circulation of medicinal devices and import substitution. Read more

Last videos

Staircase test

Staircase test assembly is designed to investigate rat forelimb movements.

Cylinder Test

Cylinder test is used to detect forelimb asymmetry, for instance, in rats with unilateral lesion of sensory motor cortex of brain.

Drug Marketing Authorization: Change is Coming

Federal Law of the Russian Federation of December 22, 2014 No 429-FZ “On Amendments to the Federal Law “On Drug Circulation” was adopted at the end of the last year



Drug registration: changes are coming

Registration of a new drug is known to be the first step in the process of its launching to the Russian pharmaceutical market. This procedure actually means regulatory examination of drug quality, efficacy, and safety that is conducted to grant subsequently an authorization for product medical use.
In our country drug registration procedure is governed by Federal Law No. 61-ФЗ “On drug circulation” dated 2.04.2010 and four amendments to it: No. 192-ФЗ dated 27.07.2010, No. 271-ФЗ dated 11.10.2010, No. 313-ФЗ dated 29.11.2010, and No. 409-ФЗ dated 06.12.2011. At the end of the last year RF Federal Law was adopted N 429-ФЗ dated December 22, 2014 “On amendments to Federal Law “On drug circulation”. Some of amendments introduced will come into effect starting from July 01, 2015, some - from January 01, 2016, and some - after more than one year, particularly, from January 01, 2017.
Alyona CHORICH, PHARMAREG Regulatory Affairs Director, told LABMGMU site readers what changes these amendments will bring to the drug registration procedure.
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Алексей Яковлевич МАЛИКОВ


XXII Russian National Congress "Man and Drugs” recently conducted focused on numerous aspects regarding new treatment approaches and support of treatment process with up-to-date medications, including innovative ones. That means that trials are the milestone stage of their development.
In St. Petersburg Pavlov State Medical University, the department of drug pre-clinical and clinical trials has been functioning for several years. It is headed by Alexey Ya. MALIKOV, who agreed to answer LABMGMU site questions. Read more
LABMGMU LABMGMU +7 (499) 340 10 14 info@labmgmu.ru 119435, Moscow, Malaya Pirogovskay str. 13-1, floor 4