New Order of Russian Ministry of Health dated 01 Apr 2016 # 200н «On the approval of new guidelines for good clinical practice» comes into force on 01 Sep 2016.
This will be one of the most significant events for Russian clinical trial markets, mainly due to the fact that these guidelines are much closer to the original GCP compared to the ones previously approved in 2003.
It should be emphasized that local «Good clinical practice» itself (that is literally a translation of GCP into Russian) in Russian Federation had the status of national standard with a lot of uncertainties with regards to its legal status.
It is, however, quite unclear what will be the life cycle of these news guidelines as it is expected that Eurasian Economic union Good Clinical Practice guidelines are approved in the nearest future and will be mandatory for each member state including Russia.
Yet, there is still one important consequence of the Order # 200н that will change the clinical trial setting dramatically – 01 Sep 2016 will be the date when the previous MoH Order # 266 of 19 Jun 2003 «On the approval of guidelines for clinical practice in Russian Federation» becomes obsolete, and this means no less than exclusion of all financial aspects of clinical trials from the new guidelines (as these are not mentioned in the new Guidelines at all), in particular, Russian MoH will not be able to refer to this order to prevent direct payment to site investigators and staff.