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KMID : 1142220140090020111
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.111 ~ p.115
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PHARM NAVI - A Shortcut to the Success of New Drug Development -
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Lee Sun-Hee
Myoung Kyung-Min
Doh Hea-Jeong
Kim Ho-Jung
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Abstract
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Despite government’s R&D investment in new drug development, commercial achievement in the global market was relatively low. This signifies the fact that government-level strategic support system is desperately required. Patients has earnestly requested development of therapeutic medicines, which are still insufficient. Meanwhile, R&D personnel has desired the better expectable drug approval and review system for prompt commercialization. Besides, providing accurate information has been required in order to overcome the limitation of domestic pharmaceutical companies, which have shown low performance in export area due to domestically oriented market; and also to quickly produce fruitful results in new and promising export markets such as China, India, and Vietnam. Recently, advanced overseas countries are promoting government-level facilitating policies to promptly launch new technology medical products, ensuring more treatment opportunities for patients. Thus, Ministry of Food and Drug Safety (MFDS) has launched a new project called “Pharm Navi” by setting goals as follows: maximize R&D investment outcome in domestic drug development to promptly provide cutting edge products, leading to global exports. “Pharm Navi” means a real-time “navigator” for development, approval, and export of domestically developed medical products during each stage of product lifecycle from development
through global sales. To this end, MFDS volunteered for the forementioned “navigator.” Another meaning of “Navi” is a butterfly in Korean. In this respect, just like an image of “butterfly” flying away, “Navi” signifies the dearest hope of MFDS that domestic pharmaceutical companies promptly bear fruitful results in new drug development to successfully realize their entry into the global market. MFDS expects current drug developers such as ventures and pharmaceutical companies to fully utilize “Pharm Navi” project to succeed in commercialization of R&D products without errors, and then to produce 1st, 2nd, and more Pharm Navi new drugs. At the time of commercialization, the new drugs as “Navi (as butterfly)” would travel around the world.
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KEYWORD
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Pharm Navi, commercial achievement, global market, navigator
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