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KMID : 1142220090040010075
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.75 ~ p.80
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Guideline on the Common Technical Document for NDA
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Chang Jung-Yun
Lim Hwa-Kyung
Kim Hee-Sung
Jin Sun-Kyung
Kim Ji-Young
Jung Shin-Ae
Choi Don-Woong
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Abstract
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The Korea Food and Drug Administration (KFDA) has made it mandatory for the Common Technical Document (CTD) to be attached to source document, which is provided for an approval of new molecular entities as of March 2009. So far, each company around the world has developed different forms of documents every time they submit documents to every different agency. Against this backdrop, the CTD has made the process efficient than ever by making the format of the world's various documents to be unified, making it more userfriendly without having to develop a separate source book in order to support an approval. The KFDA has further added a guide on developing a common technical document for medical products [attached table 3] to the 'Regulation for Pharmaceutical Items Approvals & Review [KFDA notification 2008-56]' on August 14, 2008, with a view to making the CTD more available and widely used. In addition, the KFDA has drawn up guideline describing administrative information, quality, non-clinical and clinical information in order to add an explanation of the limited meaning described in the notification. Guideline on non-clinical information included the explanation of safety (module 2.4, 2.6, and 4). ; guideline on clinical information included efficacy (module 2.5, 2.7, and 5). Both guidelines mentioned above are among descriptions on CTD preparation. General structure and summary were added to the beginning of the paper to help readers understand the concept of the CTD more easily. This paper also gives readers introductions on drawing up the CTD, which was notified on August 14, 2008. The objective of the introduction was to provide systematic support to the CTD.
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KEYWORD
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CTD, New molecular entites, Prescription drug among non-new molecular entities
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