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KMID : 1234820200210030037
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Korean Society of Law and Medicine
2020 Volume.21 No. 3 p.37 ~ p.75
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Legal Issues on the Development of New Drug: An Analysis of COVID-19 Vaccine
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Yi Hyun-Joo
Jeong Jong-Gu
Kim Hye-In
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Abstract
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There have been affluent studies on the development of new drugs and these efforts have been crystallized into a separate field of pharmacology. Yet, a normative analysis pertinent to the development of new medicine is still in a dire need, except for studies regarding medical ethics. This piece of work aims to contemplate on the legal issues concerning the development of new drug, encompassing each and every stage of the development. In order to maximize the practicability of the research method adopted as aforementioned, this work strives to analyze the developing process of COVID-19 vaccine. The first step would be to introduce the developmental stages of inventing a new drug, especially that of a COVID-19 vaccine. After then, legal issues related to each developmental stage would be discussed. Henceforth, the legal analysis would contribute to predicting upcoming legal complexities and will be able to offer normative implications for the invention of new medicines.
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KEYWORD
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Medical Law, Medical Ethics, Development of New Drug, Vaccine, COVID-19
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