To date 101 inspections for compliance with Russian GMP conducted this year


Vladislav Shestakov, the Director of the Federal Budget-Funded Institution State Institute for Drugs and Good Practices, presented the results of inspectorate activities, its future plans and spoke about the main amendments to the Federal Law No. 61-FZ “On Circulation of Medicines,”

“This year we plan to conduct about 500 inspections (101 have already been conducted). Currently, the inspectorate has 42 employees. This year there were changes in the organizational structure of the inspectorate. In addition to the department involved in the inspection of production facilities owned by foreign manufacturers, we established an expert examination department, which handles the materials and personnel work. This will be helpful both for reducing the workload of the inspectorate and for the companies. I would like to specifically mention the activities of licensing department in the past year. It conducted 119 inspections, including unscheduled ones; 92 Russian manufacturers and enterprises and 113 sites received GMP certificates.”

As for the amendments to the Federal Law “On Circulation of Medicines,” Mr. Shestakov described the initiative to introduce a parallel registration of medicinal products, which can be carried out in parallel with the inspection.