The Russian Ministry of Health has proposed amendments to Decree No. 1049, dated June 29, 2021, which regulates state oversight in the circulation of pharmaceuticals. Public discussion of the proposal will continue until the end of November 2024.
The draft document outlines detailed mechanisms for selecting organizations to conduct control measures for assessing drug quality. Under the new rules, inspections in each Russian region will occur at least once every three months, with a minimum frequency of one inspection per week.
Several factors will be considered when choosing objects for control, including the number of pharmaceutical organizations in the region, the specifics of their activities, timelines for conducting non-destructive testing, and the potential risk level associated with each facility.
To be included in the list of entities for inspection, an organization must meet specific criteria, such as having no inspections in the past two years, maintaining records in the drug monitoring system, and holding a valid pharmaceutical license. The responsibility for determining the entities to be inspected will lie with Roszdravnadzor and its regional branches.
The project also includes provisions regulating drug testing procedures, establishing clear rules for providing experts with the necessary materials for conducting repeat tests. If approved, the new regulations will come into effect in December 2024.
Source: GxP-news, November 14, 2024.
