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The Swiss Drug Regulatory Agency Swissmedic has released a Draft Guidance for the submission of so-called "Paragraph 13" applications in eCTD format.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 Swiss TPA (Therapeutic Goods Act or "Heilmittelgesetz" in German) regulates the application procedure in Switzerland for medicinal products that have already been authorised for marketing in other countries ( EU, USA, EFTA, Canada, Australia, Japan, Singapore) and where the corresponding country / countries can serve as reference countries under certain conditions.

The publication of the afore-mentioned Guidance is on schedule with step 2 of the SIMES project (implementation of electronic submissions in eCTD format) and follows a recent announcement of Swissmedic in which the agency also informed the stakeholders that is is looking for applicants that volunteer to participate on the corresponding eCTD pilot program for Paragraph 13 applications (see our related News article)

The Guidance is available for download from the Swissmedic website.

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In addition, further updates have been released by Swissmedic that are of relevance for eCTD submissions:

• A new form "Technical Validation eCTD" for the technical validation of eCTD submissions has been released that is mandatory from 01-July-2010. Before an eCTD submission is sent to Swissmedic, its technical validity must be checked. The findings of the validation check must be documented using this form.
• The form for sending Drug Master Files have been updated. With a view to eCTD compatibility the input line "eCTD Sequence" has been added to the form
• The particularities for the submission of modifications / variations in eCTD format have been included in the corresponding Swissmedic guidance leaflet. The leaflet is currently available in German and French only.

[Source: Swissmedic website]

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