In early November, President Sadyr Japarov signed a law concerning changes in the regulation of pharmaceuticals and medical devices. This step is aimed at simplifying the registration process for a number of medications. Although the topic may seem important, many do not fully understand what exactly will change and how it will affect patients, doctors, and pharmaceutical manufacturers. Ayaz Zharkynbaev, the director of the Institute of Legislation and the Rule of Law under the Ministry of Justice of the Kyrgyz Republic, explains the innovations.
According to the new law, two registration models are introduced: traditional and simplified. To understand the essence of the reform, it is important to grasp the differences between the terms "medicinal product" and "medicinal preparation."
A medicinal product is an active substance, for example, acetylsalicylic acid, which is the basis of aspirin. There are many varieties available on the market: children's, effervescent, combined, and with various dosages and packaging. Each of these types is a separate preparation that requires registration.
The registration process essentially represents the admission of a preparation to the market, confirming its safety and efficacy, as well as compliance with state requirements. In Kyrgyzstan, this function is performed by the Department of Pharmaceuticals under the Ministry of Health, while in the USA, it is done by the FDA, and in Europe — by the EMA.
Currently, traditional registration in the Kyrgyz Republic can take from six months to two years, including a long cycle of checks:
• analysis of manufacturing sites;
• evaluation of composition;
• study of clinical data;
• laboratory tests;
• expertise of the registration dossier.
Despite the necessity of such a procedure, its duration often delays access to vital medications. Even those preparations that have already been recognized in other countries cannot enter the Kyrgyz market until they have completed the full regulatory process.
In contrast, simplified registration reduces the time to 30 days. In this case, laboratory studies are not conducted, but an examination of the registration dossier is carried out, confirming the quality of the preparation.
However, even this procedure requires an expert opinion, which can introduce elements of subjectivity: "as many experts, as many opinions," emphasizes Ayaz Zharkynbaev.
A key innovation of the law is the automatic recognition of preparations registered in countries with high regulatory standards, such as the USA, the UK, South Korea, Japan, and EU countries.
The essence of this approach is that if a preparation is already registered, for example, with the FDA or EMA, Kyrgyzstan will not require repeated examinations and tests. It is sufficient to provide the registration dossier and certificate. The regulator checks the authenticity of the documents and their compliance, after which the preparation is automatically included in the state register. This reduces the time for market admission to 5–10 days.
Zharkynbaev notes: "If a preparation has been registered in a country with the strictest requirements, there is no need to check everything anew. We recognize the decision and only verify the authenticity of the documents, after which the preparation gains the right to be sold here."
What does this mean for patients and the market? Currently, innovative medicines can wait for registration for years, but now this process will take only a few days. The expertise will be replaced by document verification, minimizing the likelihood of subjective opinions. Companies will be able to bring their preparations to market more quickly if they have already received high-quality international registration, allowing for a rapid response to shortages and the needs of the healthcare system.
The mechanism of automatic registration will apply only to preparations that have undergone strict regulation at the international level. These systems involve multi-stage checks, inspections of manufacturing sites, and analysis of clinical data. Kyrgyzstan merely confirms the existence of such registration and the authenticity of the provided documents.
