RSE “NATIONAL CENTER FOR EXPERTISE OF DRUGS, MEDICAL PRODUCTS AND EQUIPMENT” MINISTRY OF HEALTHCARE

        “National center for expertise of drugs, medical products and equipment” (hereinafter National center) is a state expert organization in the distrubition chain of p>medicinal products. It was found on the 2nd October 2002, by governmental regulation №1081, by means of reorganization of RSGE “The medicinal product center “Дәрі-дәрмек”, which was found on the 17th November 1997.

        The main purpose of the National Center is the implementation of healthcare activities to ensure the safety, effectiveness and quality of medicinal products.
In accordance with the objectives, National Center performs following functions:

        The National Center has 12 territorial branches situated in the different regions of the Republic of Kazakhstan. The employees of the enterprise are highly qualified specialists, 30 of whom have academic degrees: 1 academician of NAS, 6 Doctors of Phil, 24 Candidates of Science, and 16 expert-auditors.

        The National Center incorporates the Test Center, which is responsible for safety and quality control of medicinal products and consists of 5 laboratories and division of laboratory animals.
In 2006, the laboratory on bioequivalent and relative bioavailability studies of generics, pre-clinical studies of toxicity and pharmacological activity of medicinal products was set up within Test center.
In 2008, the Test Center received a certificate of accreditation on compliance with ISO/IEC RK 17025-2001 “General requirements for the competence of testing and calibration laboratories”.

        The National Center developed State Pharmacopoeia of the Republic of Kazakhstan on the instructions of authorized organ. The Kazakhstan has received the status of observer of the European Pharmacopoeia Commission.

        In 2007, Kazakhstan joined, as an associative member, the International program of WHO on drug monitoring (Upsala, Sweden).

        The electronic program, which enables to control whole process of expertise, is used during the expertise works of organizational departments of National Center during state registration of medicinal products. There is a normative base regulating the state registration. There is expert council which evaluates the results of expertise during the state registration.

        Scientific informational-analytical journal of the National Center has been published since 2006, and is popular among pharmaceutical and medical community. It is one of the journals which was recommended for the publication of scientific works. One of the activities of National Center is the development of normative legal acts in the distribution chain of medicinal products. In recent years, more than 100 draft orders and governmental regulations were published.

        The state registration of drugs, medical products and equipment is carried out in accordance with Orders of Ministry of Healthcare 735 “On approval of the Procedure of state registration, re-registration and amendments to registration dossier of medical products (drugs), medical devices and equipment” and 736 “On approval of the Procedure of Expertise of Medicinal Products, Medical Devices, and Equipment”.