CTD

CTD = Common Technical Document is a format of file being used for the tender of the requests of marketing authorization (AM) of a drug for example.

As its name indicates it (" technical document commun"), the CTD has for principal interest to be common to the majority of the authorities of health in the world (in any case most important: Europe, the USA and Japan) for the tender of a AM request file. The CTD was developed by the European Agency of the drug EMEA, its American equivalent FDA (Food and Drug Administration) and Japanese (the ministry for health, work and the wellbeing). It is managed by ICH: International Conference off Harmonization, which harmonizes the regulation of the drugs.

Today format CTD replaced old format NTA in Europe and is obligatorily used for a new demand for AM in an European country.

There exists ECTD today.

Format CTD is composed of 5 modules.

Module 1 is administrative and does not form really part of the CTD because it is specific to each area.

Module 2 gathers the Summaries.

Module 3 is the Qualité module. One finds there the manufactoring process of the Substance activates in 3.2.S and the manufactoring process of the end product (= the drug) in 3.2.P

Module 4 relates to Safety (toxicological studies).

Module 5 relates to the Effectiveness (clinical studies).

Another use

The interest of the CTD is that it is also used for a request file as DMF or of STOCK for an active sunstance. The CTD must be used as screen " universelle" for the products touching with the pharmaceutical field.

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CTD

Contents

Another use

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