[Korea gimeunji financial newspaper reporter] Kolmar Korea is said to build an international common technical document (CTD) data for a total of 38 drugs during last year announced seven days.
International common technical document (CTD) is a standard form that was created in order for approval of drugs that can be accepted by international drug regulatory harmonization International Committee (ICH).
CTD is mandated in the country was introduced only in the New Testament from 2009, from March 20, 2016 has been expanded to target its submissions drugs and bioequivalence studies specializing in targeted drug.
Pharmaceutical has the advantage that when the building CTD data via the international level of examination can be able to supply high-quality medicines to the people, through the unification of the submitted material without domestic exports nine minutes to enhance the global competitiveness of the domestic generics for drugs .
Kolmar Korea Kim Jung Mi Senior Pharmaceutical Development Division said, "The creation of the new CTD-oriented can be called CTD built mostly for one year, as well as 38 new items to existing items for the domestic situation is a big achievement."
Kolmar Korea plans to try to respond quickly, and enable export of various products in the domestic generic drug development needs of new firms commissioned to prepare an additional CTD data on about 32 items in this year.
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