Geropharm chief Petr Rodionov said mutual recognition of medicine dossiers can lead to additional reviews, delaying market entry by nearly a year instead of the prescribed three months.
Russian pharmaceutical companies face additional requests when seeking approval for medicines in Kazakhstan and Belarus, Geropharm CEO Petr Rodionov said at the Bioprom forum in Gelendzhik. He said a procedure intended to recognize registration dossiers across markets had turned into a full review, potentially delaying a drug’s launch in a neighbouring country by nearly a year, against a regulatory limit of three months.
Russian Deputy Health Minister Sergey Glagolev said the ministry regularly raises issues with Kazakhstan in bilateral meetings. He added that some registration problems in Belarus had been partly resolved, with fewer requests and refusals to recognize dossiers. Other concerns include the time needed to set prices and the consolidation of lots in public procurement.
Deputy Industry and Trade Minister Ekaterina Priezzheva cited different approaches outside the Eurasian Economic Union: Vietnam incorporated Russian GMP regulation into its legislation, while Cuba issues certificates based on Russian inspection reports. A bilateral mechanism for mutual recognition of inspections is being prepared with Uzbekistan.
Despite the reported barriers, Russian companies continue selling medicines in Kazakhstan. Geropharm supplies Semavik, while Promomed recently began supplying Tirzetta. Kazakhstan offers foreign companies a guaranteed state order for 10 years and a 15-working-day fast-track approval for drugs cleared by U.S. or EU regulators. Alexey Fedorov of the All-Russian Patients’ Union previously noted that Russia’s Health Ministry is not on Kazakhstan’s list of regulators with a high reputation.