Clinical Study Monitoring

Monitoring / healthcare

The Association of Clinical Research Organizations presented the results of its analytical report on the clinical-research market for 2012. The past year stands out from the overall picture with significant growth in the total number of authorizations issued by the Ministry of Health — reaching 915, more than 60% more than in 2011. This is largely due to the growth of bioequivalence studies — their market share rose to 35% vs. an average of 15.1%. The number of such studies for foreign drugs increased nearly six-fold to 107 authorizations (vs. 19 in 2011). Authorizations for bioequivalence studies by Russian sponsors tripled (212 vs. 63). The number of local efficacy/safety studies by domestic sponsors more than doubled (165 vs. 80), and local studies by foreign manufacturers grew 1.8x (62 vs. 35). Meanwhile, the number of authorizations for multinational clinical studies (MCTs) remained at the same level: 369 in 2012 vs. 370 in 2011. As a result, MCTs’ share in the overall market dropped from 60% (eight-year average) to 40%. From 2005 to 2008 the total number of authorizations grew steadily, with roughly similar shares for each study type. A small dip in 2009 was probably a consequence of the global economic crisis — reductions in study numbers were seen worldwide. In 2010 Russia adopted the Law “On the Circulation of Medicines” and, as the regulatory system was restructured, authorization issuance was halted for nearly a quarter — hence the drop in 2010. In 2011 the levels recovered to pre-reform figures.

The average approval timeline in 2012 was optimized to 116 days — 14 days shorter than in 2011. Timelines improved for other types of submissions too: drug-import authorizations took 18 days (vs. 30 in 2011); biological-material import/export authorizations — 20 days (vs. 34). Overall, the share of authorizations issued on time ranges from 2% (for clinical-study authorizations) to 54.3% (for bio-sample import/export). Across all areas the number of on-time authorizations increased compared with 2011.