Skip to main content
SpringerLink
Log in

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

  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. 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 Draft guidance for industry: submitting marketing applications according to the ICH/CTD format: general considerations.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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 21 CFR 314.

  7. 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.

  8. 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.

  9. 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.

Download references

Author information

Authors and Affiliations

  1. The Weinberg Group Inc., One Market, Steuart Tower, Suite 1450, 94105, San Francisco, California, USA

    Robert I. Roth MD, PhD (Medical Director)

  2. 1220 Nineteenth St. NW, Suite 300, 20036-2400, Washington, DC, USA

    Robert I. Roth MD, PhD (Medical Director)

Authors
  1. Robert I. Roth MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Robert I. Roth MD, PhD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Roth, R.I. Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations. Ther Innov Regul Sci 42, 149–159 (2008). https://doi.org/10.1177/009286150804200207

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286150804200207

Key Words

Search

Navigation