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Delegation of the State Institute of Drugs and Good Practices took part in the Russian Pharmaceutical Forum in St. Petersburg

On May 15-16, 2018, a delegation of the State Institute of Drugs and Good Practices took part in the largest international pharmaceutical event for leaders of international and local manufacturers, distributors and retailers. Institute’s representatives spoke in two sessions: “Labeling: transition to new standards” and “GMP: secrets of successful inspections”.

On May 15, 2018 in St. Petersburg, Ms. Valentina Buchneva (head of the Eurasian office of Bosnelek pharmaceutical company) moderated a session “Labeling: transition to new standards” within the framework of the Russian Pharmaceutical Forum sponsored by the Adam Smith Institute.

In a roundtable devoted to the current issues encountered during transition to labeling of pharmaceutical products (expected to be fully functioning by the end of 2019), leading experts of the pharmaceutical industry exchanged views on results of the pilot project.

Vladislav Shestakov – director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade – commented on the interim results of the transition to pharmaceutical labeling, ‘By January 1, 2020, 99% of license holders are expected to use the monitoring system. 5 companies (1% of the total number) are behind the schedule and plan to be connected to the system during 2020. Even though it is obvious that introduction of the labeling system will extend beyond 2020, the manufacturers are certain that all essential drugs from 7N and EDL lists will be entered into the monitoring system exactly by the end of Farma-2020 program.’

To conclude the discussion, Valentina Buchneva, summed up, ‘Despite tight deadlines for transition to the labeling system, all stakeholders of the pharma market are unanimous that its implementation will benefit both business, and consumers. The pharmaceutical labeling system will enable manufacturers to correctly estimate the volume of their products circulating in the market and plan production more accurately. Additionally, labeling will reduce the number of resales on the way to the counter, and, eventually, will make medicines more affordable.’

On May 16, 2018, Mr. Ivan Gulyaev – chief specialist of the Pharmaceutical Inspection Department at the State Institute of Drugs and Good Practices – shared the most recent and cutting edge developments in the field of GMP auditing during a roundtable dedicated to ‘GMP: Secrets of Successful Inspection’. In his speech, Ivan focused on such landmarks as follow-up inspections, reduced wait time between the application and release of the conclusion, reviewing CAPA as an integral part of inspection, preparation of manufacturers for an inspection, decisions of GMP certificates, categorization of deviations, and compliance with the EAEU GMP rules. In addition, representatives of SUN PHARMA, Akrikhin, and Novartis in Russia briefly shared their overview of preparation for and going through an inspection.

“What we see is a growing interest of the pharmaceutical industry to our activities: our colleagues have many open issues related to GMP inspections. While preparing for this roundtable, we were actively communicating with the companies now present in this room‘, said Vladislav Shestakov – moderator of the session – in his address to the guests. In turn, the participants reiterated high professional level of the Russian inspectorate, and extended appreciation of the leadership of the State Institute of Drugs and Good Practices and the Ministry of Industry and Trade of the Russian Federation.

 

Presentation V. Shestakov: “A survey of pharmaceutical manufacturers on the readiness for the introduction of a labeling system”

Presentation I. Gulyaev: “Comments on manufacturers’ questions of present interest”