Common Technical Document
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.[1]
Synopsis
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989.[1]
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).[1][2]
After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada[3] and Switzerland.[1]
Paper CTDs are destined for replacement by their electronic counterparts, the eCTDs.
Contents
The Common Technical Document is divided into five modules:[4]
- Administrative and prescribing information
- Overview and summary of modules 3 to 5
- Quality (pharmaceutical documentation)
- Preclinical (pharmacology/toxicology)
- Clinical – efficacy and safety (clinical trials)
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements.[5][6]
See also
- Clinical Data Interchange Standards Consortium
- Clinical trial
- eCTD
- Harmonization in clinical trials
References
- ↑ 1.0 1.1 1.2 1.3 Junod, Valerie (2005). Clinical drug trials - Studying the safety and efficacy of new pharmaceuticals. (thesis for Faculté de droit de Genève) Bruxelles: Bruylant. p. 107.
- ↑ "Guidance for Industry, ICH M4: Organization of the CTD". U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). August 2001. https://www.fda.gov/cber/gdlns/m4ctd.pdf.
- ↑ "Guidance Document: Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format". Health Canada. Government of Canada. 2015-05-14. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/preparation-drug-submissions-electronic-common-technical-document.html.
- ↑ Jordan, Debbie (2014). "An overview of the Common Technical Document (CTD) regulatory dossier". Medical Writing 23 (2): 102. doi:10.1179/2047480614Z.000000000207. https://journal.emwa.org/regulatory-writing-basics/an-overview-of-the-common-technical-document-ctd-regulatory-dossier/article/1693/2047480614z2e000000000207.pdf. Retrieved 16 May 2022.
- ↑ Duplessis, Tanya (2022-12-12). "Introduction to CMC and its Considerations" (in en-US). https://www.bioforumgroup.com/cmc-considerations/.
- ↑ Research, Center for Drug Evaluation and (2023-11-14). "Investigational New Drug (IND) Application" (in en). https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.
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