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KMID : 1142220090040010001
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.1 ~ p.11
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Global Trends and Future Challenges in the Biopharmaceutical Sector: The Critical Role of the Regulatory Profession
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Keramidas Sherry
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Abstract
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The health product sector represents a critical economic, social and political component among developed and developing nations. In recent decades, the sector has grown, even during recessionary periods. The latter perhaps reflects the fact that the sector relates to essential human and societal needs. Further, the sector represents an important base of scientific and health related research and innovation. The health product sector also represents a regulatory challenge. In general, regulations represent a “contract” among business, government and society developed through ongoing negotiation. Regulations help to establish acceptable standards and/or a framework for managing risk. In the health sector, this risk perspective is a key driver for process and decisionmaking. The dynamics of the health product sector and regulation are constantly changing. However, the speed and direction of change may now be moving at an unprecedented pace and in directions that are not yet understood. This paper presents perspectives on some factors shaping the biopharmaceutical component of the health product sector and then examines the critical role of the regulatory profession in facilitating effective change.
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KEYWORD
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Regulatory profession, Global trends, Challenges
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