Update: SwissMedic and the eCTD

SwissMedic has added new information to its website on their plan for accepting eCTDs.  Some key points:

  • Swissmedic intends to accept authorisation applications in the eCTD format, i.e. in electronic form and with no paper documentation. In doing so, Swissmedic aligns itself with the EMEA road map for implementing eSubmissions in the EU Member States (Centralised procedure). Electronic submissions are to be accepted in eCTD format only as of 2010. The implementation of applications is to be accepted in eCTD Format only as of 2010.
  • In order to conform to the tight schedule of the introduction of eCTD by January 2010, Swissmedic needs to restrict the range of technical options, specifications and guidelines accordingly. Possible extensions to the project (such as electronic signatures, an online portal or long-term archiving) will be developed later.
  • Swissmedic is looking for companies that are willing to submit an electronic version in eCTD format (Modules 1-5), in addition to a paper submission, during the period from 1 June to 31 August 2009. See the announcement for details.

Guidance Documents are not yet available, but will be produced on the following plan:

Information on the eSubmissions business process

  • A Questions and Answer Document to handle the issues that arise most frequently (publication in July 2009)
  • Guidance for Industry on Providing Regulatory Information in eCTD Format (publication October 2009)

Information on specifications for the eCTD format for eSubmissions

  • The Swiss Module 1 specifications for eCTD (publication October 2009)
  • Swiss eCTD Validation Criteria (Publication October 2009)

Implementing eSubmissions within the SIMES project includes the following milestones:

 swissmedic-ectd1

Milestone 1: as of March 2009: publication of project information on the Swissmedic website

Milestone 2: July 2009: first version of the eCTD specifications and Swissmedic practical guidelines ready for feedback and review.

Milestone 3: October 2009: revised eCTD specifications and practical guidelines are released.

Milestone 4: January 2010: going live. Submissions in eCTD format authorised for certain types of applications.

Milestone 5: March 2010: follow-up evaluation and adjustments.

You can also find contacts for additional information on the website.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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