As of today, 40 foreign pharmaceutical manufacturers have received Russian GMP certificate. A total of 500 applications have been filed with the Russian Ministry of Industry and Trade, 121 site inspections have been conducted in Hungary, India, Germany, Slovenia, France, Switzerland, Italy, and Poland. PharmVestnik informs that 22 applications were denied based on the results of inspections.
These figures were presented at the 18th Russian Annual Conference “State regulation of circulation of medicines and medical products – PharmMedObraschenie 2016” held in Moscow on November 2-3, 2016. Vladislav Shestakov, Director of State Institute of Drugs and Good Practices, noted in his report that Gedeon Richter had taken a very responsible approach to the inspection of its sites in Hungary, Poland and Romania. Dr. Reddy’s (India), Roche Diagnostics (Germany), KRKA (Slovenia), EbbVie (Germany, Ireland), CTX (India), Polpharma, Medana (Poland), Industriale Chimica (Italy) were also among the first to have successfully passed the inspection and to have received Russian GMP certificate.
Since 2016, pharmaceutical companies are required to obtain Russian GMP certificates for their foreign factories that manufacture products supplied to the Russian market. Without confirmation that their quality standards comply with the Russian GMP, foreign pharmaceutical manufacturers may not register their new pharmaceutical products in Russia with effect from January 1, 2016, and may not re-register their drugs that are already on the market with effect from January 1, 2017.