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.
Drug Marketing Authorization: Change is Coming
Drug registration: changes are coming
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.
FAIR WORK IS MORE BENEFICIAL
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