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EU new version of the Notice to Applicants incorporating the revised version of the CTD (September 2002): http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2_en.htm M4eCTD and eCTD Q&As are published on the EMEA eSubmission website |
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CTD available on MHLW's web site : http://www.pmda.go.jp/ich/m4.htm (Japanese) |
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CTD available on FDA's web site : Organization
of the CTD : The
CTD Quality :
The
CTD Safety :
The
CTD Safety Appendices : The
CTD Efficacy :
The
eCTD : Note that the revised version of CTD (September 2002) should be republished in synchrony with the revised final "FDA general consideration guidance document" |