News Archive

Swissmedic releases modified versions of the form Technical Validation eCTD part 1

21.06.2013
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Swissmedic has released new versions of their form "Technical Validation eCTD part 1".  The forms document the results of the eCTD validation check and are to be...[more]

CH eCTD Module 1 specification 1.2 released by Swissmedic

04.06.2013
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Swissmedic has released the new version 1.2 of the Swiss Module 1 eCTD specification. The full set of documents released in this context comprises

eCTD CH Module 1 specification...[more]

Swissmedic releases updated version of Art 13 TPA guidance and checklist formal control

12.04.2013
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The Swiss Drug Regulatory Agency Swissmedic has released an revised version 3.0 of the "Administrative Ordinance Instructions: Authorisation of medicinal products...[more]

Swissmedic releases version 1.4 of their national "Q&A of Swissmedic eCTD Implementation"

18.05.2012
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The Swiss national drug regulatory agency Swissmedic has released an updated version of their "Questions & Answers of Swissmedic eCTD Implementation". The Q&A...[more]

CH: Update - Swissmedic posts translated versions of the checklist "Formal Control Art13 TPA eCTD"

02.02.2011
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In their last eCTD-relevant update from December last year (see related News article here), the Swiss Drug Regulatory Agency Swissmedic did release (amongst others)...[more]

CH: Swissmedic updates eCTD guidance documents and eCTD-related forms

04.12.2010
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The Swiss Drug Regulatory Agency Swissmedic has released updates of their national eCTD guidance documents as well as updated versions of forms for various application types...[more]

CH: Swissmedic updates Q&A document regarding eCTD implementation

26.10.2010
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Swiss Drug Regulatory Agency Swissmedic has released an updated version 1.2 of their national "Questions & Answers of Swissmedic eCTD Implementation". 

Many...[more]

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