Wednesday, September 29, 2010

What is Common Technical Document

What is Common Technical Document(CTD)in pharmaceutical industry:
Common Technical Document (CTD) is a document of requirements for a pharmaceutical product dossier for application for registration of medicines and It is used for registration in Europe, Japan and USA .

It is designed and formed by

1.The European Medicines Agency (EMEA, Europe),

2.The Food and Drug Administration (FDA, U.S.)

3.The Ministry of Health, Labour and Welfare (Japan).

The CTD for a product is also maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The Common Technical Document is consists of following 5 Modules :

1.Administrative and prescribing information

2.Overview and summary of modules 3 to 5

3.Quality (pharmaceutical documentation)

4.Safety (toxicology studies)

5.Efficacy (clinical studies)

The technical information in Module one and some subheadings of other Modules vary, with different country and their requirements.

In following countries and regions CTD is adopted

1.United States of America

2.European Union

3. Japan

4. Canada

5. Switzerland.

Several other countries are also adapting Common Technical Document (CTD).

What is eCTD ?

Electronic Common Technical Document.
Electronic equivalent of CTD is the eCTD there is an interface provided on regulatory agencies or FDA’s website to submit CTD in a electronic format , as it is easy for pharmaceutical companies and FDA or regulatory agency to receive transfer and save and process regulatory information, Common Technical Document for a particular Drug or pharmaceutical . The content and format in eCTD more or less similar to non electronic version of Common Technical Document (CTD).

No comments: