Russian companies have created about 150 reference samples for the domestic pharmaceutical industry. It is planned to have this number doubled by the summer of next year, FV reports. It is necessary to have about 10,000 samples for drug production.
The reference samples for the Russian pharmaceutical industry are going to be developed by three companies: OOO NTsSO, which is a subsidiary of the State Institute of Medicines and Good Practices (FBI “GILS i NP”), the Moscow Endocrine Plant, and Federal State Budgetary Institution Research Center for the Expert Examination of Medical Devices (RCEEMD) of the Ministry of Health of Russia.
As of December 2022, about 150 reference pharmacopoeia samples have been developed and approved in the Russian Federation. In order to avoid duplication, the lists of items for samples development and production was divided among several companies, as Vladimir Gegechkori, OOO NTsSO’s Deputy General Director for Production, said at a meeting with media representatives.
According to him, OOO NTsSO has developed about a third of the total number of reference samples.
“First we started developing reference samples of pharmaceutical substances. But the sanctions made us focus more on standardization of impurity compounds,” Gegechkori said.
The Moscow Endocrine Plant focuses on reference samples of narcotic drugs, and RCEEMD on those of other medicines. The three organizations jointly won a grant from the Agency for Technological Development. It is planned that by the summer of 2023 the total number of the reference samples reaches 300.
“In total, 3000 samples are needed for the production of drugs from the VED list, and about 10,000 for all registered medicines. According to Vladislav Shestakov, the head of the GILS i NP, Russian companies insistently invite their EAEU counterparts to cooperate, since it is quite difficult for one country to establish the production of all the necessary reference samples within a short time,” the publication writes.
As it became known earlier, the Ministry of Health intends to create a register of pharmacopoeia reference samples.
