The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.

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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA, US) and the

Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...

(Japan) starting at the

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...

International Conference of Drug Regulatory Authorities International is an adjective (also used as a noun) meaning "between nations". International may also refer to: Music Albums * ''International'' (Kevin Michael album), 2011 * ''International'' (New Order album), 2002 * ''International'' (The T ...

(ICDRA) at Paris in 1989. The CTD is maintained by the

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pha ...

(ICH). After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada and Switzerland. The Paper CTD is destined to be replaced by its electronic counterpart, the

eCTD The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format a ...

Document contents

The Common Technical Document is divided into five modules: # 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 other Modules will differ, based on national requirements.

References

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External links

ICH

Clinical research Clinical data management Pharmaceuticals policy Drug safety Life sciences industry International standards

Synopsis

Document contents

See also

References

External links