There is no place for discrimination in business!
Domestic medical drugs, which have GMP standards, will be exempt from safety assessment, just like foreign ones
In accordance with the developed project of the Order of the Minister of Health and Social Development RK (introduction of changes to the order #269), foreign drugs from the countries of ICH region, with GMP standard, are exempt from assessment of safety and quality (certification). At the same time, this measure does not apply to domestic manufacturers who have invested huge amounts of money for the construction of new plants, reconstruction, for the implementation of the GMP standard, and each batch of drugs undergoes safety and quality assessment, which costs over 80 thousand tenge.
The current Kazakh GMP standard includes practical requirements for organization of modern production of medicinal products, the manufacturing process and control of manufacture of medicinal products, taking into account the current GMP regulations of the European Union and recommendations of WHO.
Implementation of GMP requires significant financial, human resources and time, but its presence in the production is a guarantee of product quality and it facilitates the export potential of domestic factories.
NCE RK "Atameken" has repeatedly raised the issue of non-discrimination during the exemption of drugs from the certification, if they were produced according to GMP standards by domestic producers. This issue was raised by NCE at a meeting with First Deputy Prime Minister of Kazakhstan Bakhytzhan Sagintayev and the Prime Minister of Kazakhstan Karim Masimov.
On 16th of March of this year, NCE held the final discussion of the proposals of entrepreneurs for improving the arrangements for evaluating safety and quality of drugs and medical products with the Ministry of Health and Social Development of the RK and the RSE on PVC "National center of examination of medicines, medical devices and medical equipment" of the MHSD RK. Finally, the developer has taken into consideration all the arguments of NCE RK that foreign and domestic drugs should be treated the same way with no discrimination.
In addition, in order to improve the conditions of procedures of safety assessment and removal of administrative barriers, the Ministry of Health also adopted proposals of NCE on elimination of the need to provide the route map until the drug reaches the recipient in the Republic of Kazakhstan and some unnecessary input items in the conceptual apparatus of the Rules of the safety assessment and the quality of medicines and medical products.
The procedure of registration of medical equipment in the Register to ensure the unity of the measurement system in the Republic of Kazakhstan put additional burden on an entrepreneur. In this regard, the participants of the meeting decided to establish a Working Group on improving the procedures of the National center of examination of medicines, medical devices and medical equipment with the participation of representatives of NCE RK and the business community.
National center of examination of medicines, medical devices and medical equipment will re-send to NCE RK draft order of the Minister of Health and Social Development of the Republic of Kazakhstan "On amendments to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated by November 26, 2014 #269" On Approval of Rules for assessment of safety and quality of drugs and medical devices registered in the Republic of Kazakhstan", taking into account comments and suggestions of entrepreneurs.
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