Annales pharmaceutiques francaises · 2025
Comparative study of regulatory frameworks for medicinal products in Eurasian Economic Union and European Union.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Cp Keerthana, Sharma Sanjay
Аннотация
OBJECTIVE: The Eurasian Economic Union aims in harmonizing the pharmaceutical regulations among the member States while aligning with the international standards. The transition to harmonized regulation in the Eurasian Economic Union faces unique challenges, including ambiguity in regulatory pathways and alignment with international benchmarks. The objective of this study is to compare and analyze the gaps between the regulatory frameworks for medicinal products within the Eurasian Economic Union and European Union. Thus, this study explores similarities and differences in both the regulatory frameworks and provides suggestions to address these gaps.
METHODS: The study follows a descriptive and comparative analysis of the regulatory frameworks for medicinal products of Eurasian Economic Union and European Union. The data regarding the regulations were collected from the official documents, regulations and guidelines published on their official websites (EudraLex and legal portal of Eurasian Economic Union) by the Eurasian Economic Commission and European Commission.
RESULTS: The findings suggest that while the Eurasian Economic Union's regulatory framework for medicinal products shares similarities with the European Union's system, particularly in adopting mutual recognition and decentralized procedure, significant gaps remain in timelines, labelling requirements, clinical trial process, pharmacovigilance, dossier requirements and other aspects.
CONCLUSION: While the European Union has a well-established system, the Eurasian Economic Union is still navigating the operational complexities and adapting to the challenges. By aligning with the European Union's framework, the Eurasian Economic Union can increase its credibility at the global level. This study underscores the importance of the Eurasian Economic Union's ongoing harmonization effort as a major step towards strengthening its position in the global market.
METHODS: The study follows a descriptive and comparative analysis of the regulatory frameworks for medicinal products of Eurasian Economic Union and European Union. The data regarding the regulations were collected from the official documents, regulations and guidelines published on their official websites (EudraLex and legal portal of Eurasian Economic Union) by the Eurasian Economic Commission and European Commission.
RESULTS: The findings suggest that while the Eurasian Economic Union's regulatory framework for medicinal products shares similarities with the European Union's system, particularly in adopting mutual recognition and decentralized procedure, significant gaps remain in timelines, labelling requirements, clinical trial process, pharmacovigilance, dossier requirements and other aspects.
CONCLUSION: While the European Union has a well-established system, the Eurasian Economic Union is still navigating the operational complexities and adapting to the challenges. By aligning with the European Union's framework, the Eurasian Economic Union can increase its credibility at the global level. This study underscores the importance of the Eurasian Economic Union's ongoing harmonization effort as a major step towards strengthening its position in the global market.