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Russia’s pharmaceutical manufacturing oversight: licences,...

Russia’s human pharmaceutical manufacturing sector is subject...

Russia’s pharmaceutical manufacturing oversight: licences, GMP certification and inspection data

Russia’s human pharmaceutical manufacturing sector is subject to several layers of regulatory oversight, including manufacturing licensing, Eurasian Economic Union (EAEU) Good Manufacturing Practice (GMP) certification and domestic and foreign GMP inspections. An analysis of three official Russian regulatory registers shows 490 manufacturing licence records, 3,286 GMP certificate records and 592 inspection register entries. The datasets provide complementary information on the scale of regulatory activity, certification status, refusal decisions and the distribution of GMP inspection findings. The analysis is based on the Russian Ministry of Industry and Trade’s registers of pharmaceutical manufacturing...

Russia’s pharmaceutical manufacturing...

Russia’s human pharmaceutical manufacturing sector is subject to several layers of regulatory oversight, including manufacturing licensing, Eurasian Economic Union (EAEU) Good Manufacturing Practice (GMP)...
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