Overview of the most significant changes in the legislation of Kazakhstan in the Pharmaceutical sectorfrom April 1 to May 31 2026.

Review methodology
Our lawyers have prepared an overview of the most significant changes in the legislation of Kazakhstan in the pharmaceutical sector that may affect business operations. Please note that this overview does not constitute legal advice and is provided for general informational purposes only.

Period covered
We have included amendments, additions, and newly adopted regulatory legal acts introduced during the period from April 1 to May 31 2026.

1. Pilot Project on Reducing the Timeframes for the Registration of Medicinal Products Through a One-Stop-Shop Mechanism Extended Until December 31, 2026 As a reminder, since last year a “pilot project” based on the one-stop-shop principle has been in effect, under which the overall timeframe for the composite service for the registration of a medicinal product must not exceed 100 business days.
2. This pilot project has now been extended until the end of 2026 and expanded to cover all cities of regional significance. In particular, on April 4, 2026, the Joint Order of the Minister of Healthcare of the Republic of Kazakhstan No. 30 dated March 11, 2026, and the Deputy Prime Minister – Minister of Artificial Intelligence and Digital Development of the Republic of Kazakhstan No. 140/NQO dated March 12, 2026, “On the Implementation of a Pilot project for the introduction of a composite public service for the registration of medicinal products and medical devices through a one-stop-shop mechanism” (the “Order”) entered into force and became applicable. It should be noted that the maximum 100 business day period for the composite service does not include the time required for the approval of final documents, the time required for the formation of an expert council, the time required for the supplementation of the registration dossier, the time required for conducting a pharmaceutical inspection, and the time required for applicants to respond to experts’ requests.

2. Discussions on Accelerated Registration of Medicinal Products
   According to information available on the legalacts.egov.kz website, in the “Open Regulatory Acts” section, the Ministry of Healthcare and the Ministry of Digital Development of Kazakhstan are considering further simplification of the medicinal product registration process through the introduction of accelerated assessment procedures and the recognition of certain documents and regulatory mechanisms used by authorities in the European Union, the United States, Japan, Switzerland, South Korea, and Australia.
   At present, however, the proposal is available only in the form of an analytical table and does not contain detailed information regarding the planned mechanism. However, as we understand from the draft, if a medicinal product has undergone an assessment by a foreign regulatory authority using a methodology whose standards are not lower than those applied in Kazakhstan, such documents will be recognized in Kazakhstan. Overall, this is expected to significantly reduce the time required for the assessment of medicinal products. It is expected that the adoption of such a regulatory act will significantly reduce the time required to complete the medicinal product registration procedure.

3. Eurasian economic commission recommendations on conducting temperature mapping
   On 20 April 2026, the Eurasian Economic Commission adopted Recommendation No. 8 — a unified guideline for all EAEU member states, including Kazakhstan, on how to properly control temperature in medicine storage areas.
   The main purpose of the document is to provide manufacturers, wholesalers, pharmacies, and medical institutions with clear guidance on the documented study of
   temperature distribution in medicine storage areas. The document serves as a tool for minimizing the risks associated with breaches of the temperature regime during the
   storage of medicinal products.
   The document recommends measuring “cold spots” and “hot spots” taking seasonality into account, identifying areas that are not suitable for the storage of medicinal products,
   repositioning the sensors, and it allows for changing the designated use of certain warehouse zones.