Navigating the Evolving Eurasian Economic Union's Pharmaceutical Landscape: Streamlining Drug Registration for Market...

The Eurasian Economic Union was formed with the aim of achieving economic integration among the five countries, i.e., Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan. They have established a common pharmaceutical market and are focusing on improving their position in the global market. Understanding the newly harmonized regulations in EAEU is vital for ensuring timely market access and patient safety. It presents an opportunity for pharmaceutical companies to access a unified market and expand their market and eliminate individual country-specific barriers. Given the limited literature available and the ongoing transition period set to conclude by 2025, this review will provide insights into the marketing authorization procedure for medicinal products, its dossier requirements and market opportunities for the pharmaceutical companies within EAEU. A descriptive analysis of regulatory pathways was undertaken by reviewing the EAEU rules and official documents from their websites. This review reveals that EAEU has introduced two major marketing authorization pathways: decentralized and mutual recognition procedure, which is similar to that of the European Union's approach. The projected market volume indicates the significant growth of the pharmaceutical sector and the importance of understanding the new unified regulatory pathway and the other development initiatives taken by the union. Even though the EAEU has harmonized its regulatory framework, the system is still in its initial stages of full implementation.