were as reference documents. However, the situation changed significantly in April 2009,when Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a notification6 that paper dossiers were no longer required if applicants submitted the eCTD as the original dossier. Previously, the entire paper dossier was requested even if the eCTD was submitted as an original. Although paper Modules 1 and 2 are still required for review when the eCTD is submitted as the original dossier, it is no longer necessary to submit paper Modules 3, 4 and 5. As Figure 1 indicates, as the benefits of the eCTD have become better understood, the number of applications in eCTD format as the original dossier has increased.
For More Information please use the below link: TOPRA Regulatory Rapporteur: The implementation of eCTD in Japan
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