The Association of Clinical Trials Organizations (ACTO) (Russia) recently published an overview of clinical trials market in 2019. Overall, it noted positive trends in the market with a year on year increase of 14.2% in permits granted for clinical research.
Highlights from the report
In 2019, the Russian Ministry of Health issued 746 permits for clinical research (14.2% higher than in 2018). All types of research have shown an increase. There was an increase in studies initiated by international sponsors - 34.6% (it should be noted that this increase is based on low level 35 in 2019 v 26 in 2018). The report also noted a 19.2% increase in trials initiated by local sponsors (155 in 2019 v 130 in 2018). The number of permits for bioequivalence studies of foreign-made generics also grew (80 vs. 69) and Russian-made generics (163 vs. 141) increased by approximately the same percentage (15.9% and 15.6%). The number of permits for international multicenter clinical trials (ICI) increased by 9.1% to 313 compared to 287 in 2018.
The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and theEuropean Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines.
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