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KMID : 1142220140090020159
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.159 ~ p.165
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Perception Analysis of Regulatory Specialist in Pharmaceutical Companies on Common Technical Document
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Kim Jung-Ran
Park Hye-Kyung
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Abstract
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Common Technical Document is a standardized format for regulatory dossier to promote development of new drugs among ICH members(ICH, International Conference on Harmonization). In Korea, it is implemented to application of new drug since Mar. 2009. From 2015, MFDS(Ministry of Food and Drug Safety) has plan to expend the range of application that it needs to analyze perception on Regulatory specialists who work for pharmaceutical companies. Based on the result, we can cope with the extended application. Totally 65 RA specialists participated this survey. They answered that they well know about the overall CTD and the effect on obligation of CTD to pharmaceutical companies, they evaluated that it can cause discomfort to local companies and preparation delay of submission dossier owing to its difficulties. 33.8% of RA specialists have experience on CTD submission that almost two third of RA specialists didn’t. In case of range of application and implementation timing, 55.4% answered that CTD is required. Because it can help to fluent communication between health authority officer and RA. However another 44.6% RA didn’t agree to CTD’s necessity to value added product or generic product. Among them, 82.6% considered that extended application to generic products are not cost-effective compared to its investigation and preparation ability and its level are statistically significant according to their assets, sales turnover, experience on regulatory affair and willing to participation of CTD education(p < 0.05). MFDS is plan to revision of relevant regulation since 2015. However it seems not sufficiently share the needs and benefits of CTD. Based on this result, health authority should deliberate about the implementation schedule and extended application considering negative answer from industry. At the same time, CTD should be implemented after enforcement of preparation ability of local companies first by more active education.
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KEYWORD
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Common Technical Dossier, Regulatory specialist, Perception analysis, Extended application of Common Technical Dossier
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