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KMID : 1142220210160020117
Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.117 ~ p.127
Regulatory Implication of Pharmaceutical Strategy for Europe
Park Sylvia

Abstract
This study reviews¡¸Pharmaceutical Strategy for Europe¡¹which the European Committee published in November, 2020. The EC aims to revise EU¡¯s pharmaceutical legislation based on the recommendations of the Strategy by the end of 2022. The Strategy indicates challenges which the European pharmaceutical system faced and makes recommendations. The Strategy seeks to ensure patients¡¯ accessibility to quality and safe medicines, while boosting global competitiveness and innovation of European pharmaceutical industry. It also stressed enhancing resilience of the system. The Strategy proposes flagship initiatives and actions which covers a wide spectrum of regulation and policies including R&D, intellectual property rights, health technology assessment, procurement, price, market competition. In Korea, it needs to evaluate the current pharmaceutical system with reg ard to t he u ltimate object o f the system a nd e xplore our s trategy.
KEYWORD
Pharmaceutical, European Union, Strategy, Accessibility, Innovation, Resilience
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