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 applicable for eCTD submissions.

The updates consist of

• New version 1.3 of the "Questions & Answers of Swissmedic eCTD Implementation": Changes mainly address Swissmedic`s progress of their three-phased eCTD implementation project, the addition of guidance for the submissions of PSURs in eCTD format and newly introduced Questions 3-48 to 3-51 in chapter 3 ("Questions about the Submission"). Version 1.3 of the Q&A is available as "clean" and "track change" version from the Swissmedic eSubmission Documentation website (see link at the bottom of this article)
• New version 1.2 of the "Guidance for Industry on Providing Regulatory Information in eCTD Format": Changes mainly address Swissmedic`s progress of their three-phased eCTD implementation project and the addition of guidance for the submissions of PSURs in eCTD format. Version 1.2 is available as "clean" and "track change" version from the Swissmedic eSubmission Documentation website
• Modifications in the form Application Authorisation / Variation: The implementation of eCTD submissions for further Swissmedic authorisation processes entails minor formal adjustments. Moreover, it must now be indicated in the form if a variation of product information is caused by a submitted PSUR. The form is available in English, German and French language.
• Modifications in the form used for Renewals: A field has been added to specify the corresponding eCTD sequence. In addition, clarification has been included that the cover letter is mandatory. The updated form is currently available in German only.
• A specific checklist for the formal control of eCTD sequences used for Applications acc. to §13 TPA. The checklist is currently available only in German language. Translations in English and French will follow shortly.

[Source: Swissmedic website]

Related News:

 CH: Update - Swissmedic posts translated versions of the checklist "Formal Control Art13 TPA eCTD" - 02.02.2011 15:21

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