The Ministry of Health of the Republic of Kazakhstan has submitted for public discussion a draft order amending the rules for compiling the list of orphan diseases and medications for their treatment. The document is available for comment until May 25, 2026.
The amendments relate to the Ministry of Health's order of October 16, 2020, No. ҚР ДСМ-135/2020, and are aimed at improving the mechanism for including drugs in the list for the treatment of rare diseases.
As noted in the explanatory note to the draft, the main goal of the changes is to make the procedure more transparent and understandable, and to increase the participation of relevant specialists in decision-making.
One of the key innovations will be the involvement of the Expert Council under the Ministry of Health. This body is expected to conduct a professional assessment of new drugs, analyzing their effectiveness and the appropriateness of their use for specific orphan diseases.
Following expert evaluation, the report will be sent to the Formulary Commission of the Ministry of Health, which will make the final decision on whether to include the drug in the list of orphan drugs.
Thus, the procedure will be structured in several stages: first, an expert assessment, then a review by the commission and the adoption of a final decision.
In addition, the project provides for editorial and clarifying changes to regulatory documents concerning the timing and format of analysis conducted by scientific organizations, as well as the activities of the Working Body.
Another change affects the Order of the Minister of Health dated October 20, 2020, No. ҚР ДСМ-142/2020 "On approval of the list of orphan diseases and medications for their treatment." The plan is to align the list of diseases with the prevalence rates of rare diseases.
The draft also establishes a provision according to which a medicinal product may be included in the list of orphan drugs only if it has a positive recommendation from the Formulary Commission and in accordance with the medicinal product's category.
The Ministry of Health believes the proposed changes will help improve access to orphan drugs and specialized medical care for patients with rare diseases, as well as expedite patient access to necessary treatment. The document can be found at: https://legalacts.egov.kz/npa/view?id=15822235
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
The amendments relate to the Ministry of Health's order of October 16, 2020, No. ҚР ДСМ-135/2020, and are aimed at improving the mechanism for including drugs in the list for the treatment of rare diseases.
As noted in the explanatory note to the draft, the main goal of the changes is to make the procedure more transparent and understandable, and to increase the participation of relevant specialists in decision-making.
One of the key innovations will be the involvement of the Expert Council under the Ministry of Health. This body is expected to conduct a professional assessment of new drugs, analyzing their effectiveness and the appropriateness of their use for specific orphan diseases.
Following expert evaluation, the report will be sent to the Formulary Commission of the Ministry of Health, which will make the final decision on whether to include the drug in the list of orphan drugs.
Thus, the procedure will be structured in several stages: first, an expert assessment, then a review by the commission and the adoption of a final decision.
In addition, the project provides for editorial and clarifying changes to regulatory documents concerning the timing and format of analysis conducted by scientific organizations, as well as the activities of the Working Body.
Another change affects the Order of the Minister of Health dated October 20, 2020, No. ҚР ДСМ-142/2020 "On approval of the list of orphan diseases and medications for their treatment." The plan is to align the list of diseases with the prevalence rates of rare diseases.
The draft also establishes a provision according to which a medicinal product may be included in the list of orphan drugs only if it has a positive recommendation from the Formulary Commission and in accordance with the medicinal product's category.
The Ministry of Health believes the proposed changes will help improve access to orphan drugs and specialized medical care for patients with rare diseases, as well as expedite patient access to necessary treatment. The document can be found at: https://legalacts.egov.kz/npa/view?id=15822235
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
