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Ministry of Health prepares changes to drug registration rules in Ukraine

2026-08-19

Ministry of Health prepares changes to drug registration rules in Ukraine

The Ministry of Health of Ukraine has developed a new plan for transitioning to European quality standards for medicinal products. The main goal of these changes is to update the requirements for drug bioequivalence so that they comply with modern European Union standards.

One of the agency's key tasks is to keep time-tested generics on the market. Generics are affordable analogs of original drugs that have the same composition and effectiveness. They are an important part of the healthcare system, as they allow patients to purchase necessary medications at lower prices.

The Ministry plans to actively lobby for a special mechanism that will allow Ukrainian rules to be adapted to European ones without compromising the accessibility of medicines. This means that the transition period will be aimed at ensuring that patients do not experience a shortage of drugs during the implementation of the new requirements.

It is expected that these steps will help increase trust in both domestic and imported drugs, and will also bring the Ukrainian pharmaceutical industry closer to EU standards. The Ministry of Health emphasizes that the safety and effectiveness of medicines remain the top priority in this reform.

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