News Archiv

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

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"

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

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

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

Many...[more]

CH: Swissmedic adapts national variation legislation document to incorporate eCTD requirements

The Swiss Drug Regulatory Agency Swissmedic has adapted their national variation legislation guide "Verwaltungsverordnung Anleitung Meldepflichtige Änderung" to...[more]

CH: Swissmedic updates eCTD checklist "Formal Control"

The Swiss Drug Regulatory Agency Swissmedic has released a new version of their national form "Checklist Formal Control". This new version has become necessary due...[more]

CH: Swissmedic releases guidance for pilot phase of Paragraph 13 applications in eCTD format and further eCTD related updates

The Swiss Drug Regulatory Agency Swissmedic has released a Draft Guidance for the submission of so-called "Paragraph 13" applications in eCTD format. Paragraph 13 of the...[more]