Qodirov Mirzoxid Muhtarovich - Head of the State "Center for Expertise and standardization of medicines, medical devices and medical equipment" SUE.

During the years of independence, the Republic of Uzbekistan has undergone radical changes in all areas, including pharmaceuticals. The republic has begun to create its own system of regulation of relations in the field of circulation of medicines, medical devices and medical equipment, to develop its own regulatory framework, that is, to go its own way.

Active work is being done to harmonize and mutual recognition of normative and legislative acts leading to the integration of the pharmaceutical industry into the global pharmaceutical industry, expansion of foreign markets, ensuring the quality, efficiency, safety and popularity of medicines, medical devices and medical equipment, eliminate barriers to international trade.

In accordance with the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 181 of May 25, 1995, in order to ensure a unified state policy of the Republic of Uzbekistan in the field of regulation of circulation of medicines and medical devices, The State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment (SUE "SCESMMDME") was established.

One of the main activities is the organization and implementation of quality control by the state, simultaneous registration and permitting the use of local and foreign drugs, medical devices and medical equipment in medicine in the Republic of Uzbekistan , coordination of activities and management of institutions and organizations engaged in the examination, standardization, certification of pharmaceutical and medical products, conducting examinations, laboratory and clinical trials, as well as approval of regulatory documents.

Coordination the activities of the Center is carried out by four committees: Department of Pharmacopoeia, Pharmacology, New Medical Equipment, Drug Control and Metrology.

In order to control the production of medicines and medical devices, as well as the activities of the national network of pharmacies, there is a Pharmaceutical Inspectorate under the State Unitary Enterprise is operating.

Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 427 of 5.12.2002 allowed SUE "DVTBTTESDM" to become a serious obstacle to the entry of counterfeit and substandard drugs and medical products into the country.

After the adoption of the Law of the Republic of Uzbekistan "On Certification of products and services" in 1993, the certification sector was established under the Center (1997) and later reorganized as a Certification body for medicines and medical products (2003).

The Center has 4 accredited laboratories that directly control the quality of registered and certified medical products.

One of the important departments is Printing department the tasks of which is to publish the State Register of Medicines and Medical Devices, the journal "Pharmaceutical Bulletin of Uzbekistan", methodological literature and others. At present, the number of drugs registered by the Ministry of Health is 8270, of which 3371 are foreign, 1738 are CIS countries and 1127 - domestic; medical-diagnostic products (in vivo) -27, medical devices and medical equipment - 1947 (including in vitro diagnostic products).

Specialists of the Center are actively participate in regional conferences, symposia and seminars, including as organizers, dedicated to the problems of national and international importance in the field of standardization, registration, certification, as well as in the regulation of the elimination of counterfeit and substandard drugs and medical devices. 

All this indicates that the Republic of Uzbekistan has a system of strict state control over the quality of medical and pharmaceutical products, which guarantees the quality, efficiency and safety of medicines and medical devices, medical products and in vitro diagnostic tools.

QUALITY POLICY

The quality, safety and effectiveness of medicines, medical devices and medical equipment come first.

The main activity is the implementation of high-quality and objective work (tests) to assess the safety, quality, effectiveness of medicines, medical devices and medical equipment produced in the Republic of Uzbekistan or abroad.

The main goal is to protect consumers from substandard medicines, medical devices and medical equipment, as well as to help increase the competitiveness of domestically produced products in the international market. The management and staff of the Center believe that their main task is to assess the safety, quality, effectiveness of medicines, medical devices and medical equipment in accordance with international and national standards.

A quality management system has been developed and put into practice to perform the assigned tasks. Management and staff provide a high level of service provided by the organization.

An important criterion for the quality of services provided is to meet the requirements, requests and expectations of applicants in accordance with the terms of the contract or agreed terms, as well as to ensure full confidence in the Center.

The Center is provided with appropriate resources and personnel to fulfill its tasks and provide high quality services to organizations and the population.

The Center guarantees:

• high qualification of staff;
• quality and timeliness of work on safety, quality, efficiency assessment;
• objectivity and reliability of evaluation results;
• adherence to the confidentiality of information;
• guarantees continuous improvement of the quality management system to meet the requirements of applicants and other interested customers.

Management provides:

• that all documents of the quality management system are developed in accordance with the requirements of national and international standards;
• compliance with the requirements of the quality system is mandatory for all employees.

The set goals will be achieved through:

• continuous training of staff;
• understanding of quality policy and ensuring the effectiveness of the quality system by all employees;
• understanding the requirements of applicants (consumers);
• increase the responsibility of employees;
• continuous audit of the quality of work performed.

The management and staff of SUE "SCESMMDME" are directly involved in the implementation of quality policy.