Using the biologic license application or new drug application as a basis for the common technical document.
With the introduction of the common technical document (CTD), many writers in the biotech and pharmaceutical industries are now required to submit dossiers in this format. The format of the CTD is not extremely difficult from the familiar documents of the Biologic License Application (BLA) or New Drug Application (NDA). The CTD can be mapped to existing areas of the BLA or NDA. The components of the CTD are discussed and references to the current guidance worldwide are provided to assist the writer.
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MaryAnn
M
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. mfoote@amgen.com
D004282:Documentation / Q000379:methods* / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D038622:Internationality; D008004:Licensure / Q000331:legislation & jurisprudence* / Q000592:standards*; D040541:Marketing / Q000592:standards*; D014481:United States