Common Technical Document


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Common Technical Document

A format adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for organising applications of pharmaceuticals for human use to the regulatory authorities.
References in periodicals archive ?
ICH Harmonised Tripartite Guideline, The Common Technical Document for the Registration of Pharmaceuticals for Human Use, Efficacy--M4E(R1), Clinical Overview and Clinical Summary of Module 2 Module 5: Clinical Study Reports.
One such guideline is the Common Technical Document (CTD), which describes a common format for the summary documents required for submission to regulatory agencies in the United States, Europe, and Japan.
SDTM is the standard for clinical data tabulations, and is specified through the FDA electronic Common Technical Document (eCTD) Guidance as the model for submitting clinical data to the FDA in support of marketing applications.
He said that in order to further strengthen pharmaceutical registration system, DRAP will start receiving registration applications on Common Technical Document format in early 2017.
A draft guidance for writing an ISE is also available, as is its European counterpart, the Common Technical Document (CTD) M4E Revision 1 (R1); search in the "Guidance (Drugs)" section of the website for this information.
He was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees including the Common Technical Document working group.
dot" documents), but they do give enough information to facilitate the creation of templates for protocols and investigator brochures (E6 guideline (4)), clinical study reports (E3 guideline (5)), and the summaries that make up Module 2 of the Common Technical Document (M4 guideline (6)).
This increases efficiency, fosters confidence in the integrity of the documentation record, and facilitates the preparation of materials for submission in the electronic Common Technical Document (eCTD).
In 2000, a new global focus on harmonized content and information sharing through technology was promoted via the ICH Guidelines on the Common Technical Document (CTD).
Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Also, in some companies, regulatory medical writers work closely with regulatory professionals to develop meeting requests and briefing packages for the investigational new drug (IND) application submission as well as write clinical summaries and clinical overviews for new drug application (NDA) or common technical document (CTD) submissions.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission.