|
Common Techinical Documentation |
Saurabh Gupta, Manish Mathur, Shweta Bansal, Ritu M Gilhotra |
The 'Common Technical Document' or 'CTD' is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. Common Technical Document (CTD) is essential for understanding the properties of drug substance to reduce the formulation problem in the process of drug development and also to save time and cost of development of product. CTD required in New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submission, containing quality information, are usually formatted in a manner consistent with the organization of guidance for industry. Pharmaceutical firms submit application using the CTD which is common format agreed by ICH. Several guidelines are available in United States Food and Drug Administration (USFDA) and International Conference on Harmonization (ICH) for regulatory specification to improve the quality. According to ICH all technical requirements for the application of drug approval were harmonized in CTD. In this paper we focus on the all technical requirements for application of drug approval harmonized in CTD format. An overview of CTD format, its organization, principles and scopes is educative for the pharmaceutical and medical professionals.
Key words: CTD, eCTD, ICH, FDA, specifications.
|
|
