Updates on eCTD Specification in Europe, Japan

EMEA and PMDA provided an update on eCTD status at the traditional “Update on Regulatory Authority Experience” session. Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007: Centralised Procedure: 14 new applications, 80 variations National Procedures (as reported by national compentent authorities): 659 new applications, 611 variations Mr. Buxton also...

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