Achieving Simultaneous Submission in an Electronic Regulatory Market

Posted 01 June 2010 | By

The landscape of global regulatory submissions has evolved since the implementation of the International Conference on Harmonisation (ICH) Common Technical Document (CTD). The CTD's specifications were first developed by ICH members from the US, Europe and Japan to standardize the format of regulatory dossiers by providing a common structure for the quality, safety and efficacy data in Modules 2 through 5. Some emerging markets have followed ICH's lead and are recognizing the CTD as their official regulatory submission format.


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