Government mandates monthly monitoring of medications for safety and compliance
Uzbekistan Enhances Post-Market Surveillance of Pharmaceuticals
In an effort to bolster the safety and quality of pharmaceutical products in circulation, the government of Uzbekistan has introduced a new regulation for post-market surveillance. The Cabinet of Ministers approved the regulation, which is set to take effect on January 1, 2025, as announced in a document published on Lex.uz.
The regulation establishes a comprehensive system for monitoring pharmaceuticals after they have entered the market, with the goal of evaluating their compliance with technical standards. The Center for Pharmaceutical Safety, operating under the Ministry of Health, will be responsible for managing post-marketing control. The center will conduct regular assessments of products through control purchases and laboratory testing.
Under this new regulation, the Center for Pharmaceutical Safety will carry out monthly control purchases of drugs and medical supplies. By the 25th of each month, the center will develop a plan for post-market surveillance, selecting products based on their international non-proprietary names (INNs) using an electronic system for risk analysis.
In addition to planned checks, the center will also respond to citizen complaints or reports regarding product quality, safety concerns, illegal distribution, or side effects. In such cases, control purchases will be based on the product’s trade name rather than its generic equivalent.
Specialized staff from the center will conduct control purchases using official bank cards. For products not readily available in pharmacies, such as medical equipment or goods stored in manufacturers’ warehouses, samples will be taken directly from the producers.
Samples collected must be delivered to a laboratory within two days of purchase, with testing to be completed within five business days. If necessary, the testing period can be extended to 15 business days. The laboratory will generate reports and submit them to relevant authorities.
Following the laboratory’s assessment, a formal conclusion will be issued by the working body within three working days. The Center for Pharmaceutical Safety will then have up to three additional days to determine necessary actions based on the findings, which could include product recalls, warnings, or other corrective measures.
This new regulatory framework aims to strengthen oversight of the pharmaceutical market in Uzbekistan, ensuring that only safe and effective products are available to consumers. By implementing rigorous post-market surveillance measures, the government seeks to enhance public health and maintain quality standards in the country’s pharmaceutical sector.
