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Common Technical Document Translation
The Common Technical Document (CTD) is a set of specifications for a dossier to
register medicines. After the United States, European Union and Japan, the CTD has
been adopted by several other countries including Canada, Australia and Switzerland.
The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.
It's difficult for different foreign regulatory authorities to effectively review the various
formats of technical documents submitted by life sciences companies for consistent
approval standards. Suppose you are looking to register your medicines with
international regulatory authorities. One essential requirement is to professionally
translate your new drug’s technical information on quality, safety, and efficacy to ensure
compliance with the harmonized electronic submission and good regulatory review
practices that are widely required internationally.
MedTrans provides industry-leading, centralized document translation solution that is
perfectly engineered to meet the requirements of the Common Technical Document
(CTD) translation standards.
The Common Technical Document is developed by the International Conference on
Harmonisation (ICH) and divided into five modules and all of which must be adequately
translated into the required languages to be eligible for harmonized electronic submission
in the corresponding countries. The five modules are:
Module 1: Administrative information and prescribing information
Module 2: Common technical document summaries (Overview and summary of the
drug’s quality, safety, and efficacy on humans.)
Module 3: Quality (pharmaceutical documents which describe the format and
organization of the chemical, pharmaceutical, and biological data relevant to the
Module 4: Safety (nonclinical study reports, preclinical documents which provide
objective and criti