Indian Ministry of Health Drafts Notification Regarding CTD Preparation

India will soon be adopting a Common Technical Document (CTD) for the import, manufacture and marketing approval of new drugs. India’s Union Ministry of Health has produced a draft notification for the preparation of the CTD. The new format will be implemented to create greater ease of use, to prevent omission of important data or analyses, and to improve speed of review.  Using the CTD is expected to reduce the time and resources required to compile global applications for registration by a significant amount. Until now, applicants have used many different formats for the filing of their application materials, making the review process difficult and time consuming.

In addition to raising the Indian standard of quality, the CTD will create structure across the entire application filing process and prevent approval delays.

Japan, the European Union, the United States and others have already adopted a CTD format. Though India has already used such a system for biological products since 2009, this will be the first time the CTD will be used in India for pharmaceutical products.