About 200 medicines risk losing their registration certificates
The use of about 200 medicines may be suspended in Russia, after which their registration certificates will be revoked. This concerns manufacturers that fail an inspection for compliance with EAEU good manufacturing practice. About 200 medicinal products are at risk: their use in Russia may be suspended, and their registration certificates may be cancelled. This concerns medicines whose manufacturers are denied issuance of an EAEU GMP certificate, according to a presentation by Diana Chizhova, head of the Drug Registration Division of the Department for Regulation of Circulation of Medicines and Medical Devices of the Russian Ministry of Health, presented at the XI All-Russian GMP Conference on September 17.
How many reached the single market
All applicants that wanted to extend the validity of national registration certificates submitted applications to bring them into compliance with EAEU requirements, Diana Chizhova reported. According to her data, about 12,000 applications for bringing into compliance were received by the Russian Federation as the reference state. Almost all of them have been processed. “About 750 dossiers are under review. We expect them to be completed in the near future,” noted the representative of the industry department. According to her, about 200 dossiers for bringing into compliance were received by Russia as the reference state. Almost all products have been “brought into compliance.” They have the right to be manufactured under the old registration certificate for another 180 days. Those products that were denied bringing into compliance may “continue to circulate” what has already been produced and placed into civil circulation, Diana Chizhova noted. For 500 products that did not manage to apply for bringing into compliance, the government has extended their registration certificates for one year as a temporary measure. Manufacturers of these medicines must also submit an application for registration in accordance with EAEU law, Diana Chizhova added. In her opinion, for the industry the end of the transition period means that “now it is especially important to concentrate efforts and focus on the quality of registration dossiers and on good manufacturing practices.” “If you entered, say, the Russian Federation as the reference state with an already valid certificate from another member state of the union, we accept it. But if you entered without it and then went somewhere to another state to conduct an inspection—we have had such cases—we encounter an unpleasant situation. We informed the Russian Ministry of Industry and Trade, it puts you on the plan, and you have already undergone inspection somewhere else; that is not allowed,” Diana Chizhova commented on the practice. The inspection is conducted by the reference state, she continued. The applicant may apply to another state in case of refusal to conduct it, she clarified, and warned those who have registered but have not submitted an application for a GMP inspection that the use of their products will be suspended and their registration certificates will be revoked. Currently, according to Russian Ministry of Health data, 200 products are at risk. “Of the 195 notifications received by the Russian Ministry of Industry and Trade and by GILS and NP that products without GMP certificates have been submitted to the Russian Ministry of Health, 77 sites have been inspected. But more than half have not come with an application for inspection. Today we can state that more than 20 products, within three years from completion of registration, have still not applied for an inspection,” added Madina Sottaeva, head of the Department for Inspection of Medicines Manufacturing of the FSBI “GILS and NP.”
The Russian Ministry of Health speaks of 200 products, while the Russian Ministry of Industry and Trade speaks of 195 production sites. “FV” sent requests to the press services of the agencies to clarify this point. Background Since 2013, compliance with the GMP standard has been required to obtain a license for medicine production in Russia and to register products. At first it was Russian GMP, and since 2021 it has been EAEU GMP. But for placing products into civil circulation, confirmation of compliance is not required—confirmation of batch quality is sufficient. A paradoxical situation has developed: every Russian pharmaceutical manufacturer regularly confirms its GMP compliance, while many foreign colleagues received their certificate once—usually upon registration of products—and have not undergone inspections since. Or they underwent them, but with a negative result: the identified deviations did not allow a conclusion of GMP compliance to be issued. This was discussed at the BioProm forum in October 2025. “I won’t give statistics until we finish it, but it turned out to be extremely surprising even for me, although I had assumed that far from all [undergo inspection for GMP compliance],” said then Director of the Department for Development of the Pharmaceutical and Medical Industry of the Russian Ministry of Industry and Trade Dmitry Galkin. According to him, since 2019, the Russian Ministry of Industry and Trade has not conducted scheduled inspections due to two consecutive moratoriums: first because of the coronavirus pandemic, and then because of economic sanctions against Russia. During this time, some pharmaceutical manufacturers that had previously been in good standing “relaxed significantly.” “Quality and production departments must be periodically bucked up so that they do not slide into routine and do not forget the goals of their work, so we are resuming inspections,” Dmitry Galkin warned. Constant maintenance of the production quality assurance system is the manufacturer’s responsibility, he stressed. “Russian manufacturers have it, Eurasian manufacturers have it, but all the rest, strangely enough, do not have it in their own local market,” explained the representative of the Russian Ministry of Industry and Trade, and suggested that Deputy Minister of Health of the Russian Federation Sergei Glagolev return to the issue of eliminating this legal collision. The Russian Ministry of Industry and Trade proposed a combined period: a deferred rule on mandatory GMP for all sites, with a reserve of time in case a certificate could not be obtained through the manufacturer’s own fault, rather than because of inspectorate throughput (currently there are no queues for inspection). During this reserve period, the manufacturer would have to conduct laboratory quality control of products. “Since this is a story with a transition period, it is extremely important to launch it as early as possible,” insisted Dmitry Galkin.
Порядка 200 лекарств рискуют лишиться регистрационного удостоверения » Фармвестник
