FSBI NCESMP of the Ministry of Health of Russia Scientific Center for Expertise of Medical Products

History

2022

Access to Honest Mark data as part of the drug registration and examination procedure

On August 22, 2022, the CRPT announced that the Russian Ministry of Health will use information from the Honest Sign National System for Digital Labeling of Goods as part of the drug registration and examination procedure. The examination of drugs before release into civil circulation is carried out by the Scientific Center for the Examination of Medical Products of the Ministry of Health of Russia (NCESMP), it is also responsible for serial control of immunobiological drugs with the issuance of a protocol and conclusions on the compliance of drugs with the requirements.

Deputy Head of the Ministry of Health of Russia Sergei Glagolev sent a letter to the operator of the labeling system at the Center for the Development of Advanced Technologies with a request to provide the scientific center with access to the data of the labeling system in the status of a "control body." This status gives access to complete information about the movement of any drugs, and representatives of control and supervisory authorities have similar rights.

In accordance with the requirements of the legislation, samples of drug batches sent for examination must be produced in industrial conditions, that is, marked, and withdrawn from circulation in the labeling system as selected for control, explained Alla Trapkova Deputy General Director of NCESMP.

According to her, the conclusions of the scientific center are subsequently received by the Roszdravnadzor system and are used when making decisions on issuing a permit for the introduction of the drug into civilian circulation.

At the same time, control over the removal of samples received at the center from the labeling system is necessary to assess the number of drugs entering the sale and prevent re-injection of unaccounted packages into the market, added Alla Trapkova.

The Center for the Development of Advanced Technologies confirmed the receipt of the letter and reported that the corresponding access to the Scientific Center was granted.

These measures will make it possible to implement an additional control point for the regulator using the marking system. Application of marking data. The use of labeling data at the stage of examination of drugs will reduce to zero any attempts to introduce illegal drugs into circulation, commented on the head of the Pharma commodity group of the Center for the Development of Advanced Technologies Yegor Zhavoronkov.

More than 90 thousand participants are registered [FGIS MDLP Monitoring of Drug Product Movement| in the drug labeling system] (as of August 2022), of which 438 are manufacturers. Drug labeling began in Russia on July 1, 2020. According to Roszdravnadzor, as of August 2022, 100% of drugs that are introduced into civilian circulation are marked.

Earlier, the deputy head of the Ministry of Industry and Trade Viktor Yevtukhov said that in the first 4 months of 2022, Russian state bodies requested data to the labeling system more than 4 million times. The growth of appeals amounted to 353% compared to the same period in 2021. Access to statistics on the state of commodity markets and information on potential violations of product turnover within the competence of departments through personal accounts was provided to more than 3,000 representatives of 16 government agencies that participate in information exchange with the labeling system, the Ministry of Industry and Trade noted.

The first narrow-profile laboratory of pharmaceutical research in Russia opened in Moscow

In June 2022, the Scientific Center for the Examination of Medical Products of the Ministry of Health of Russia was opened at Skolkovo, Russia's first narrow-profile research laboratory for pharmaceutical research (LFI). The area of ​ ​ the institution is 156 square meters. m, there it is planned to annually conduct about 100 studies of drugs at various stages of their life cycle. Read more here.