Kazakhstan is preparing to introduce major reforms aimed at accelerating the approval and import process for medicines produced in the United States and Europe. Under the proposed rules, drugs that have already been approved by leading international regulators, including the U.S. Food and Drug Administration and the European Medicines Agency, could receive authorization to enter the Kazakhstani market in as little as 15 days.

The move marks a significant shift from the country’s current regulatory system, which requires lengthy approval procedures before imported medicines can become available to patients. Authorities believe the new approach will help improve access to modern treatments and reduce delays in bringing internationally recognized medicines into the country.

Who Announced the Reforms?

The planned reforms were outlined by Askhat Aimagambetov, a member of Kazakhstan’s Majilis, the lower chamber of parliament. Writing on his public channel, Aimagambetov said amendments have already been made to the relevant legislation in order to simplify and modernize the pharmaceutical registration process.

According to the lawmaker, the initiative is designed to remove unnecessary bureaucracy while maintaining safety standards. He emphasized that the reforms are intended to create a more efficient and practical system for approving medicines that have already undergone rigorous international testing and certification.

How Long Does Drug Registration Currently Take?

Under the existing system in Kazakhstan, the process of registering imported medicines can take up to 210 days. Pharmaceutical companies must currently go through multiple stages of review, including scientific expertise, pricing approvals, administrative checks, and various regulatory procedures before a drug can officially enter the market.

Health officials and lawmakers have argued that such lengthy timelines can slow patient access to important treatments, particularly innovative medicines already widely used in other countries. The government now hopes to dramatically shorten these waiting periods through the proposed changes.

How Will the New System Work?

Under the new procedure, all major stages of the approval process will be combined into a single integrated service. This means that expert reviews, pricing decisions, and other required approvals would be handled simultaneously instead of separately.

According to Aimagambetov, the streamlined system could reduce the time between an application being submitted and the medicine becoming available from roughly seven months to only two weeks. Officials believe this approach will simplify procedures for pharmaceutical companies while allowing patients to receive access to medications much more quickly.

Why is Kazakhstan Making These Changes?

Kazakhstan says the reforms are aimed at improving public access to safe and effective medicines while reducing duplication in the regulatory process. Authorities argue that medicines already approved by highly respected international regulators should not be forced to undergo years of repeated examinations before being introduced into the Kazakhstani market.

Supporters of the reform say the changes will help the healthcare system respond faster to patient needs and global medical developments. The initiative is also expected to make Kazakhstan a more attractive market for international pharmaceutical companies.

“If a drug has already passed strict testing in the US or Europe, there’s no point in retesting it for years,” Aimagambetov stated while explaining the rationale behind the amendments.

What New Powers will the Ministry of Health Receive?

The proposed amendments would also expand the authority of Kazakhstan’s Ministry of Health. Under the new rules, the ministry would gain the right to independently initiate the registration process for medicines considered important or necessary for the healthcare system, even if pharmaceutical manufacturers do not formally submit applications themselves.

Officials say this mechanism could help prevent shortages and ensure faster access to critical drugs in cases where companies delay entering the market or show limited commercial interest.

Are There Changes to Quality Control Measures?

Yes. The reforms also include new quality control measures related to pharmaceutical production inside Kazakhstan. Raw materials imported for domestic drug manufacturing would undergo testing directly at border checkpoints rather than later in the supply chain.

Authorities believe this approach will strengthen oversight of imported pharmaceutical ingredients while also reducing delays in the production process. The government says the measure is intended to improve both efficiency and safety standards in the domestic pharmaceutical sector.

What Impact Could the Reforms Have?

If fully implemented, the reforms could significantly change how quickly international medicines become available in Kazakhstan. Patients may gain faster access to innovative therapies and internationally recognized treatments that are already widely used in Western healthcare systems.

The changes could also reduce administrative burdens for pharmaceutical companies, encourage greater foreign participation in Kazakhstan’s healthcare market, and improve the overall efficiency of the country’s drug approval system. Officials hope the reforms will ultimately strengthen public healthcare services while aligning Kazakhstan’s pharmaceutical regulations more closely with international standards.