Clinical trials in EAEU
The Eurasian Economic Union or EAEU is a political and economic union of countries in Eastern Europe and Central Asia, including Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia. The Eurasian Economic Union (EAEU) has a regulatory framework for drug registration and clinical trials.
The EAEU is a significant market with a total population of over 180 million people and a combined GDP of approximately $1.9 trillion (as of 2020). The size of the pharmaceutical market in the EAEU was estimated at $31.6 billion in 2019 and is expected to grow at a CAGR of 6.7% from 2020 to 2027.
Russia is the largest pharmaceutical market in the EAEU, accounting for more than 80% of the market. Kazakhstan is the second largest market, followed by Belarus and Armenia. Kyrgyzstan is the smallest market within the EAEU.
The EAEU was created to promote the free movement of goods. In May 2017, three years after the EAEU Treaty was signed, the EAEU countries ratified the regulatory framework for a common market for pharmaceuticals, creating a set of documents to be implemented in all countries and fully adopted by 2025. The guidelines are based on the following principles and are designed to be consistent with EU guidelines:
- Harmonization and unification of member states' requirements;
- Ensuring uniformity of mandatory requirements for the quality and safety of medicines circulating on the territory of the EAEU;
- Adoption of uniform rules in the field of drug circulation;
- Development and application of equal and comparable methods of research and control;
- Harmonization of the legislation of the Member States in the field of control (supervision) of the circulation of medicinal products;
- Implementation of the process of development, clinical and non-clinical studies, marketing authorization, production, sale, advertising, transportation, promotion, destruction, etc. of medicinal products by the authorized institutions of the Member States.
The EAEU guideline describes two ways of drug registration, which have become the official procedures from the beginning of 2021:
The mutual recognition procedure, where you file an application for marketing authorization in one member state and, after approval, apply for recognition in the other states (duration: 210 calendar days for the registration + additional 90 calendar days for recognition);
The decentralized procedure, where you submit a marketing application simultaneously in the EAEU countries, choosing one member state as a reference (duration: 210 calendar days).
Medicinal products registered before December 31, 2020 must comply with the new EAEU standards by December 31, 2025. If the process is not completed, the marketing authorizations will cease to be valid.
The compliance process has a duration of 100 calendar days (excluding clock stops) + 90 calendar days for mutual recognition.
If the product has been registered in at least three Member States for five years or more, a certificate of registration without an expiry date will be issued. In other cases, the authorities will grant the standard five-year registration certificate.
Recognition of clinical trials conducted in any of the EAEU member countries implies agreement on the general principles of their conduct. The regulations cover all stages of the clinical trial process, including the design, conduct, monitoring, and reporting of trials. They establish requirements for the protection of human subjects, including informed consent, confidentiality, and ethical considerations. They also provide guidelines for the selection and monitoring of trial sites and investigators, and for the handling and storage of trial data.
EAEU regulations require that clinical trials be conducted in accordance with international standards, such as the ICH guidelines. They also require that clinical trials be registered in a publicly accessible database, such as the yet-to-be-established EAEU Clinical Trials Register (currently, data are available in national registries).
Overall, the EAEU has established a comprehensive regulatory framework for the conduct of clinical trials to ensure the safety and efficacy of medicines in the region and the registration of medicines.
Overall, the EAEU represents a significant market for pharmaceutical companies, with a large population and growing demand for healthcare products and services.
Clinical Trials Landscape in the EAEU
According to the Russian Ministry of Health, in 2020, the number of clinical trials conducted in Russia alone was approximately 1000 ongoing trials in 2023. It is important to note that Russia is the largest country in the EAEU and accounts for the majority of clinical trials conducted in the region.
The number of clinical trials conducted in other EAEU member states, such as Kazakhstan and Belarus, is comparatively lower, but has been increasing in recent years.
Regulatory Landscape for Clinical Trials
Approval of clinical trials in the member states takes 3-4 months. There are many similarities in the process of clinical trials approvals in the member states. Some countries accept documents in the Russian language excluding patient specific documentation.
There is no centralized procedure for approval of clinical trials in the EAEU.
It should also be noted that it is necessary to obtain an export license in all member countries in order to import the drug.
Smooth Drug Development - CRO in the EAEU
Smooth Drug Development works in the main countries of the Eurasian Economic Union. We conduct clinical trials for registration in the EAEU. In addition, we include the countries in EAEU in global clinical trials for drug registration in the USA and EU, as well as for MA in other regions.