India regulatory authority to adopt CTD format for NDAs

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On 28 October 2010, India’s Central Drugs Standard Control Organization (CDSCO) released new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.


The CTD has already been developed for Japan, the EU and the US through the International Conference on Harmonisation (ICH) process.

Up until now, applicants in India have used many different approaches in organising the information for NDAs and the differences in organisation of data in each application has made reviewing difficult and has often resulted in the omission of critical data or analyses, in turn leading to unnecessary delays in approval.

By adopting the CTD format the CDSCO hopes to improve approval times for the importation, manufacture and marketing of new drugs. In addition, this should also simplify the exchange of regulatory information between India and other regulatory authorities.

The guidance document is available for comment for 60 days on the website of the CDSCO.

Source: CDSCO

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