The Union ministry of health has come out with a draft notification on the preparation of Common Technical Document (CTD) for import, manufacture and marketing approval of new drugs. Implementation of CTD is expected to significantly reduce time and resources needed by industry to compile applications for global registration.
The main aim behind implementing a common format of submission is to make the reviewing of each application more easy and also to avoid omission of critical data or analyses. Omissions of such data can result in unnecessary delays in approvals. CTD not only help in raising the Indian standard but also will help to bring a proper structure to the whole process of filing an application.
This guidances have been developed for Japan, European Union, and United States through the International Conference on Harmonisation (ICH) process. Now India will also adopt CTD format for technical requirements for registration of pharmaceutical products for human use though the same is already in use for biological products since 2009.
The regulations under Drugs and Cosmetics Rules 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe the information required for approval of an application to import or manufacture of new drug for marketing. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organising the information and the differences in organisation of data in each application has made reviewing more difficult.
The CTD guideline presents the agreed upon common format for the preparation of a well-structured CTD for applications that will be submitted to regulatory authorities. A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. In addition, exchange of regulatory information between regulatory authorities will also be simplified.