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KMID : 1142220100050010001
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.1 ~ p.11
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Study on Developing a Risk Management Strategy for Living Modified Organisms (LMO) Using Raw Materials of Medicinal Products
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Choi Min-Joung
Oh Il-Ung
Park Youn-Joo
Ahn Kwang-Soo
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Abstract
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Biotechnology is one of the advanced scientific fields that utilizes living organisms to make the desired products. It is expected to be the driving force for the national economic growth in the 21st century and help the people make healthier lives. Although biotechnology is promising and has competitiveness, it may introduce completely new organisms that do not exist in the nature. In order to prospectively control and/or prevent potential risks from those new genetically modified organisms to environments and human health, the Act on Transboundary Movement of Living Modified Organisms ("the LMO Act") was enacted, coming into effect of the Cartagena Protocol on Biosafety from January 2008. However, Article 3 of the LMO Act allows the exception of "human medicinal products" from the scope of the LMO Act, provided that those products are covered by a separate regulation on risk assessment. In addition, Article 4 of the LMO Act states that "if provisions are prescribed in other laws", they should be followed. Accordingly, the acts and/or regulations regarding pharmaceutical affairs have to be updated to cover the LMOs to be used in the manufacture of medicinal products. In assessing the risks of medicinal products, there are two kinds of risk assessment; assessment of risks to human health (human health risk assessment) and assessment of risks to environments or ecosystems (environmental risk assessment). Since medicinal products are developed for the purpose of being administered into humans, human health risk assessment is fully performed. Therefore, the scope of this study was limited to environmental risk assessment. First, the present usage of LMOs for the manufacture of medicinal products that may be released into environments were investigated to identify the scale of the market subject to regulation and determine the future demand. Further, the guidelines on environmental risk assessment during review of clinical study protocols for gene therapies that are possibly released to environments were investigated and analyzed. since it is expected that the relevant industries are in great confusion on implementation of regulations on biosafety control of LMOs, documents explaining the regulations and publicity activities were performed to minimize such confusion. Outcomes from this study will be used to update regulations on environmental risk control of LMOs for the manufacture of medicinal products.
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KEYWORD
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Living Modified Organism (LMO), environment risk assessment, medicinal products
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