eCTD.it UserGroup

Swissmedic ha rilasciato una versione aggiornata (versione 1.0.1) delle specifiche del modulo 1. Riportiamo un estratto di questo annuncio: 

The Swiss Module 1 Specification together with style sheet, change control document, implementation guidance and a demo submissionis available from the Swissmedic eSubmission page (see link below).

1.    Content requirements for section 1.7.6 "Paragraph 13 Additional Documentation" (Paragraph 13 deals with applications on basis of obtained EU authorization) have been changed from "mandatory" to "optional"
2.    Furthermore availability of sections 1.5.1 "Swissmedic Bioequivalence Trial Information Form" and 1.5.2 "Documents on the Reference Product" has been changed from XOR to and AND/OR so both sections can now be assigned content in parallel.

The release of version 1.0.1 has no impact on the previous announcement that Swissmedic will accept eCTD as electronic-only submissions starting with 01-Jan-2010. Both regional M1 specification versions 1.0 and 1.0.1 will be accepted.

[Source: Swissmedic website] 
 

Evidenziamo inoltre come Swissmedic abbia schedulato alcuni eventi specifici per eCTD (sempre sul sito di Swissmedic):

• Electronic Submission Event Swissmedic: The Introduction of eSubmissions in eCTD format, 10.12.2009 and 19.01.2010, Bern.

 Links:www.swissmedic.ch/zulassungen/00933/00937/index.html