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Abstract

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has produced a unified dossier for drug applications, the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD). The CTD drug application format is now favored by the Food and Drug Administration (FDA) as well as worldwide regulatory authorities.

The technical information submitted in a CTD, and the organization of the information, is carefully specified in guidance documents. However, sponsors have latitude in how data are presented and important messages are formatted in the compilation of a CTD application. Ultimately, the timeliness of FDA's review and approval status of a drug submission is best served by preparation of a high-quality CTD. Insights and recommendations are provided to help maximize the potential for a successful outcome.

Keywords

New drug dossier Drug marketing application

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References

Food and Drug Administration. Draft guidance for industry: submitting marketing applications according to the ICH/CTD format: general considerations. Available at: http://www.fda.gov/cder/guidance/4707dft.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: M4: organization of the CTD. Available at http://www.fda.gov/cder/guidance/45390.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: M4: the CTD—quality. Available at: http://www.fda.gov/cder/guidance/4539Q.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: M4: the CTD—efficacy. Available at http://www.fda.gov/cder/guidance/4539E.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: M4: the CTD—safety. Available at: http://www.fda.gov/cder/guidance/4539S.pdf. Accessed May 1, 2007.

21 CFR 314.

Food and Drug Administration. Guidance for industry: M4S: the CTD—safety appendices. Available at: http://www.fda.gov/cder/guidance/4539sap.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: structure and content of clinical study reports. Available at http://www.fda.gov/cder/guidance/iche3.pdf. Accessed May 1, 2007.

Food and Drug Administration. Guidance for industry: M3: nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals. Available at http://www.fda.gov/cder/guidance/1855fnl.pdf. Accessed May 1, 2007.

Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations

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