Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines

高度个性化药物对欧洲药品监管体系带来的挑战

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Abstract

The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed.

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