The first group of volunteers are vaccinated…
Recruitment Challenges for COVID-19…
The unified market for medicines for the member states of the Eurasian Economic Union (EAEU) has been officially functioning since May 6, 2017. The key takeaway for the pharmaceutical world was of course the opportunity to have a drug registered in one of the member states and obtain market authorization through a simplified procedure within the rest of the countries of the Union. This development without doubt added to the appeal of the region among global pharma and biotech companies looking for expansion and further growth opportunities. It was not until the end of 2019 when the first medical device was registered on the territory of the EAEU. In this overview we will look at the considerations from the perspective of clinical research and drug registration one should be aware of when looking at the region as a destination for trials.
Despite the fact that since 2017, the EAEU has been witnessing sustainable growth through positive dynamics in key economic indicators, there has been continuous discussion on a number of key topics including the issues on the integration and the general effect of a single space for drug circulation in the territory of the Union.
The unified pharmaceutical market will, first of all, significantly improve the quality, safety and efficacy of drugs distributed within the territory of the member countries and will help them become more competitive in the global arena. The results of drug quality control will be recognized by all control laboratories of the union. In addition, it will provide access to the market for high-quality drugs and reduce the barriers related to the individual characteristics within the regional pharmaceutical markets.
Regulation is an essential component within any clinical trial. The single market regulation will include the world's best practices for assessing the quality, safety and efficacy of medicines and medical devices (good clinical, manufacturing and distribution practices). Since 2011 48 technical regulations have been adopted.
As of today, the EEU’s unified registry of authorized drugs contains the up-to-date list of all the issued marketing authorizations which amount to 73 entries. The Ministry of Health of Russia issued the first marketing authorization as per EEU’s standards in November last year.
Eugenia Radkova, medical writer, OCT Clinical: This project without doubt represents a solid foundation with conditions for the circulation of safe, high-quality and effective medicines on the territory of the entire union. That in turn, facilitates essentially the overall access of hundreds of millions of EAEU citizens to high-quality medicines.
However, at this stage there are still difficulties that need to be addressed. Each of the countries has been developing at a different pace. There are many things in common, but there are also differences in the regulation practices, therefore this will become a fundamental leap toward the harmonization of the legislation with the European one.
Irina Petrova, Director of Clinical Operations, OCT Clinical: The single Eurasian market will undoubtedly become beneficial for each of the member states: domestic drug manufacturers will have more opportunities to enter foreign markets. Having applied once, it will be possible to obtain authorization across several more countries. with a rather large population (Note: currently there are more than 20 million-plus cities across the EAEU; the total population of the Union countries is 183.8 million).
Harmonization of recommendations on clinical design and conduct with the global standards, a CTD format for a registration dossier in the CTD which all global sponsors are familiar with, all this will cause a synergy effect from the pooled potential of different countries.
Tatiana Goruishkina, registration manager, OCT Clinical: The new regulatory field offers several advantages related to dossier compilation. First of all, there is the harmonization of the EAEU pharmacopeia with the globally recognized ones and the absence of the need to reconsider the existing analysis methods and requirements for the quality of drugs. Secondly, no less relevant is the introduction of a master file system for pharmaceutical substances similar to international practice (safety of the confidential information from the closed part of the dossier and a more convenient procedure to submit the information about the active substance to regulatory authorities).
There are still issues that remain unresolved, however. For example, at the moment, there is no regulation on how the inspection bodies should interact. Another issue, which requires further consideration is the introduction of the GMP system of the union within each pharmaceutical enterprise that operates in the union market.
Current state of affairs
It is obvious that a full-fledged transition to a single pharmaceutical market and the development of unified standards is a difficult and time-consuming process, and in a sense painful. Nevertheless, all the undertaken measures have allowed significant progress. Currently, the authorized bodies of the EAEU countries have already confirmed the possibility of a unified electronic registration.
On the official website of the union there is an announcement on the completion of the first issue of the EAEU Pharmacopoeia. After the scientific and technical editing of 157 draft general pharmacopeial articles, the first issue included articles containing general requirements for clinical trials, requirements equipment performing analytical study etc.
Another important milestone is the complete alignment of inspection procedures with the GMP Union rules. The first two applications for such an inspection were accepted in Belarus (August 2018). A manufacturer who is ready to undergo the proper procedure can send an application to any of the inspecting bodies within the EAEU countries. The parties agreed to inform each other in advance about upcoming inspections and the possibility of joint participation in the inspection, which significantly increases the transparency of the procedure.
At the moment, an agreement has been signed among five member countries (Russia, Armenia, Belarus, Kazakhstan, Kyrgyzstan). In addition, about 50 other countries have been expressing interest toward cooperating with the union.
About the Eurasian Economic Union
The Eurasian Economic Union is an international organization for regional economic integration. It has international legal personality and is established by the Treaty on the Eurasian Economic Union.
The EAEU provides for free movement of goods, services, capital and labor, pursues coordinated, harmonized and single policy in the sectors determined by the Treaty and international agreements within the Union.
The Member-States of the Eurasian Economic Union are the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation.
The Union is being created to comprehensively upgrade, raise the competitiveness of and cooperation between the national economies, and to promote stable development in order to raise the living standards of the nations of the Member-States.