Main directions for developing the pharmaceutical system discussed
A meeting took place at the Ministry of Health to discuss enhancing the operations of the Center for Pharmaceutical Product Safety, aligning with international standards.
The meeting was attended by the Minister of Health and by Dragos Gutu, an independent international pharmaceutical expert engaged by the Center.
During the meeting, the international expert presented the Minister of Health with the results of a comprehensive monthlong audit of the Center’s activities and key areas of the national pharmaceutical regulatory system.
During the audit, the processes related to state registration of medicines, certification, pharmacovigilance, GxP-compliant inspections, clinical trials, and post-marketing surveillance were examined in detail. The parties also reviewed the legislative framework and practical regulatory mechanisms governing these areas. The identified issues and shortcomings were discussed, and recommendations were made to resolve them.
Considerable focus was given to enhancing the Center’s activities to align with advanced international practices and standards, improve regulatory process efficiency, and reach the World Health Organization’s Maturity Level 3 – WHO ML3.
Following the meeting, consensus was achieved to create targeted tasks and a concrete action plan to enhance the Center’s activities, considering the recommendations from the international expert and the audit findings.
A. Rustamov, UzA