Committee for Industrial, Radiation, and Nuclear Safety Received Two International ISO Certificates

A local medical equipment manufacturer has received a certificate of conformity to international standards. The certificate was presented to the company "NAM BIOTEST" MCZH by the quality management systems certification body at the Center for Pharmaceutical Product Safety under the Ministry of Health.

Significance of Certification

Alisher Temirov, Director of the Center for Pharmaceutical Product Safety, emphasized while presenting the certificate to the enterprise head that implementing quality management standards in the production of medical devices is an important factor for the sustainable development of the country's pharmaceutical industry, increasing the competitiveness of local manufacturers, and strengthening export potential.

Requirements and Advantages

He also noted that introducing a quality management system based on international requirements is particularly important for ensuring the safety, quality, and reliability of the manufactured products. This certificate confirms that the processes for producing medical devices and diagnostic tools, as well as the organization of quality control at the enterprise, comply with international standards.

This not only strengthens the company's position in the domestic market but also expands opportunities for exporting products to international markets.

About NAM BIOTEST

"NAM BIOTEST" MCZH, founded in 2019, is one of the leading local enterprises in Uzbekistan specializing in the production of in vitro diagnostic tools and laboratory reagents. The enterprise produces rapid diagnostic tests, ELISA test kits, laboratory reagents, and other diagnostic products using modern technologies.

ISO 13485 Standard

It is important to note that the ISO 13485 standard establishes international requirements for the quality management system for medical devices. Its implementation contributes to improving production processes, risk management, ensuring compliance with current regulatory requirements and consumer needs, as well as increasing the company's competitiveness and trust in global markets.

The issuance of this certificate is another practical result of the continuous reforms being carried out in the field of medical device production in Uzbekistan, aimed at the widespread adoption of international standards, supporting local manufacturers, and ensuring the healthcare system has high-quality and safe medical goods.

The introduction of a new testing method for gels, ointments, and other topical medicinal products within the Eurasian Economic Union may be implemented. This was reported by the Eurasian Economic Commission.

Changes in Bioequivalence

The EEC Expert Committee approved the draft changes to the rules for conducting bioequivalence studies of medicinal products. According to this draft, artificial membranes can be used instead of donor skin when testing gels and ointments.

Advantages of the New Approach

According to the Commission, this approach is a modern replacement for complex and expensive studies, which allows for the simplification of the testing process and reduction of manufacturers' costs.

Bioequivalence studies are conducted to compare the properties of alternative drugs with an already known medicinal product. Furthermore, the Expert Committee approved documents concerning microbiological monitoring during drug production and the uniform display of active substance names in applications and the unified register.

Coordination and Next Steps

The Minister of Technical Regulation of the EEC, Alexander Subbotin, announced that an agreement has been reached on the discussed issues. However, the changes have not been finalized yet. It is planned that the projects will be reviewed by the EEC Collegium between August and October.

Temporary mandatory restrictions on electricity supply for two hours were introduced in some districts of Uzbekistan to prevent overloading in the power transmission networks.

Regions and affected consumers

These restrictions were implemented in specific districts of the Kashkadarya, Jizzakh, Khorezm, and Tashkent provinces. According to a statement from the Ministry of Energy press service, the outages affected various settlements.

Details of the outages

Specifically, 1750 consumers in the Kukdala and Chiroqchi districts of Kashkadarya province were temporarily without electricity. Outages also affected 1200 consumers in the Sharof Rashidov and Zomin districts of Jizzakh province.

Affected districts and consumers

Additionally, 1300 consumers in the Shovot, Gurlan, and Qushkupir districts of Khorezm province, as well as 1000 consumers in the Tashkent and Zangiota districts of Tashkent province, temporarily lost access to electricity.

Energy situation

It is reported that on July 16, the unified energy system of Uzbekistan registered a daily electricity consumption of 291 million kWh, while production amounted to 295.4 million kWh, which was a record figure for the summer season.

Calls and measures

It was also noted that special teams in the regions are promptly fixing malfunctions occurring in some networks due to abnormally hot weather. The Ministry urges the population to use electricity reasonably and economically.