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EDQM e eCTD - Chiarimento |
Dopo la pubblicazione del documento in cui EDQM spiegava quali formati elettronici (NeeS e eCTD) accettava e di cui abbiamo già dato notizia, probabilmente in difficoltà rispetto alcune incongruenze nelle specifiche eCTD indicate nel documento stesso ha pubblicato un chiarimento (io direi una rettifica) sul tema. Se quindi andate sulla pagina iniziale del sito EDQM http://www.edqm.eu/en/News-amp-General-Information-164.html si può leggere la seguente news: EDQM revised procedure for electronic submissions: Clarification(05/10/09) In line with the implementation of eCTD submissions at the level of national competent authorities, the EDQM announced at the beginning of August its readiness for accepting electronic submissions in the format of eCTD or NeeS dossiers, and published a revised procedure and some requirements. It should be stressed that e-CTDs prepared in compliance with the ICH guidance and specifications are fully acceptable for EDQM; these are the preferred specifications which manufacturers should follow when preparing their electronic dossiers. The EDQM revised procedure for electronic submissions was published to serve as guidance to those companies who would not yet be ready to implement the ICH specifications and who would still wish to apply electronically to obtain a certificate of suitability. Such companies are asked to apply the guidance described in the revised procedure.
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