In 2018, more than 6.5 thousand examinations of medicines and medical devices were carried out.
At the Central Communications Service (CCS) site, the National Center for Drug, Medical and Medical Equipment Expertise of the Ministry of Health of the Republic of Kazakhstan (NTSELS) summed up the results of the year 2018 in terms of its main activities: expertise and assessment of the safety and quality of drugs and medical products, monitoring side effects drugs, as well as analysis of the pricing of medical products, etc.
The event was attended by the Chairman of the Committee of Pharmacy of the Ministry of Health of the Republic of Kazakhstan Lyudmila Burabekova and Acting General Director of the National Center for Ecology and Social Action Kanat Yerzhanov.
Our center is a state expert organization in the field of circulation of medicines and medical devices and assesses the quality and safety of medicines and medical products sold in the Republic of Kazakhstan. In other words, before medicines and medical products are delivered to the shelves of Kazakhstan’s pharmacies, we conduct a comprehensive examination of them, evaluate safety, efficacy and quality, as well as compliance with established requirements, said Acting General Director of NTSELS Kanat Yerzhanov.
In 2018, NTSELS did a great job in terms of entering the pharmaceutical market of the Eurasian Economic Union (EAEU). As a result, Kazakhstan issued the first in the territory of the EAEU countries a registration certificate of a medicinal product for medical use. Also within the framework of the EAEU, Kazakhstan accepted 23 applications from foreign and domestic pharmaceutical manufacturers to conduct an examination of medicines as a reference state.
In total, in 2018, NTSELS conducted 6537 examinations of medicines and medical devices, which is 18% more compared to 2017, and about 63,000 conclusions were issued on the safety and quality of medical products.
It is worth noting that since 2006, the requirements of the State Pharmacopoeia of the Republic of Kazakhstan are harmonized with the main pharmacopoeias of the world – European, British Pharmacopoeias, and the US Pharmacopoeia. Kazakhstan has been the official observer of the European Pharmacopoeia of the Council of Europe since 2006, a full member of the US Pharmacopoeia Convention since 2010 and an observer of the International Conference on Harmonization of Technical Requirements for Medicinal Drugs for Medical Use (ICH) since 2016. NTSELS testing laboratories are accredited for compliance with international quality standards and the requirements of the European Directorate for the Quality of Medicines (EDQM), and have the status of an associated member of the OMCL Common European Network (GEON). According to a WHO benchmarking conducted in 2018,
Effective work on pharmacovigilance and monitoring of side effects of drugs, carried out in the NTSELS, prevents access to the shelves of Kazakhstan pharmacies of hazardous drugs. In total, from January to December 2018, NTSELS received more than 3,200 card-reports of cases of side effects of drugs. Of these, some medications were temporarily or completely removed from circulation.
In terms of pricing in 2018, NTSELS conducted work on analyzing and shaping drug price regulation approaches, which include conducting external and internal reference pricing, introducing pricing principles based on international experience, and applying a diversified approach to distributors and suppliers.
Due to this, today a flexible regressive system of retail markups has been developed, which will make it possible to set marginal prices for medicines twice a year. Note that with this, the authority to regulate prices for medicines in Kazakhstan is assigned to the Ministry of Health of the Republic of Kazakhstan.
Source: Central Communications Service of the Ministry of Information and Communications of the Republic of Kazakhstan