Comparative Analysis of Personalized Medicine Regulatory Frameworks and Challenges in the Usa and Europe
DOI:
https://doi.org/10.52783/jns.v14.3638Keywords:
Personalized Medicine (PM), Regulatory Frameworks, FDA (Food and Drug Administration), EMA (European Medicines Agency), Policy Harmonization, Precision Medicine, Rare DiseasesAbstract
Objective: This study compares and contrasts the regulatory frameworks for personalized medicines (PM) in the EU and the USA, aiming to identify key differences, evaluate the current state of the field, and propose strategies for global harmonization.
Methods: A literature review was conducted to analyze regional regulatory policies, action plans, and initiatives related to personalized medicine. The study focuses on the regulatory bodies FDA and EMA and their impact on the development and approval of PMs.
Results: The review reveals that while the FDA in the USA supports faster PM development through conditional clearances and smaller clinical trials, the EMA's centralized approval process in the EU facilitates access across Member States. The global demand for PM, driven by the need to treat rare diseases and neurological, pulmonary, and infectious conditions, highlights regulatory challenges and the need for increased collaboration.
Conclusion: Global harmonization of regulatory frameworks is essential for accelerating PM development and ensuring equitable access. Continued collaboration between regulators, researchers, and stakeholders will be crucial to overcome existing roadblocks and foster innovation in personalized medicine.
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