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Navigating The Evolving Eurasian Economic Union's Pharmaceutical Landscape: Streamlining Drug Registration For Market Access.

Home
Research Domains
Commerce, Management, Tourism And Services
Human Resources And Industrial Relations
Employment Equity And Diversity
Navigating The Evolving Eurasian Economic Union's Pharmaceutical Landscape: Streamlining Drug Registration For Market Access.

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

C P Keerthana¹, Sanjay Sharma²

¹Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's, NMIMS, Deemed to be University, Vile Parle West, Mumbai, Maharashtra, 400056, India.

Therapeutic Innovation & Regulatory Science

|April 19, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

The Eurasian Economic Union (EAEU) harmonizes pharmaceutical regulations for market access. This review details marketing authorization, dossier requirements, and opportunities within the unified EAEU market.

Keywords:

Decentralized procedure EAEU regulatory framework Economic integration Market growth potential

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Area of Science:

Pharmaceutical regulatory affairs
International market integration
Eurasian Economic Union (EAEU) policy

Background:

The Eurasian Economic Union (EAEU) aims for economic integration among Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.
A common pharmaceutical market is established, necessitating understanding of harmonized regulations for market access and patient safety.
Limited literature exists on the EAEU's evolving pharmaceutical regulatory landscape, with a transition period ending in 2025.

Purpose of the Study:

To provide insights into the marketing authorization procedure for medicinal products within the EAEU.
To detail dossier requirements and identify market opportunities for pharmaceutical companies.
To analyze the regulatory pathways and their implications for market entry.

Main Methods:

Mutual recognition procedure

Regulatory harmonization

Descriptive analysis of regulatory pathways.
Review of EAEU rules and official documentation from relevant websites.
Examination of marketing authorization procedures, including decentralized and mutual recognition pathways.

Main Results:

The EAEU has implemented two primary marketing authorization pathways: decentralized and mutual recognition, mirroring the European Union's model.
Projected market volume indicates substantial growth in the pharmaceutical sector within the EAEU.
The unified regulatory framework, while harmonized, is in the early stages of full implementation.

Conclusions:

Understanding the EAEU's harmonized regulatory framework is crucial for pharmaceutical companies seeking market access and patient safety.
The EAEU presents significant market opportunities due to its unified approach and projected sector growth.
Ongoing development and implementation of EAEU regulations require continuous monitoring by stakeholders.