On November 1, SwissMedic, the regulatory agency for Switzerland, updated their guidance for eCTD, including a new version 1.4 of the Data Type Definition (DTD), and validation rules. This corresponds to the recent Revision 4 of the Therapeutic Product Ordinances (HMV4). These rules area available starting January 1, to become mandatory in June. If you are submitting the new information prior to January 1, SwissMedic has additional details as to where to put new items in the existing regional Module 1 XML backbone.
Some of the changes are purely cosmetic. Once nice item is that SwissMedic will now use the term “pharmaceutical form” (like the rest of the world does) instead of “galenic form” – although a lot of their documentation, and the eCTD structure, still use “galenic.” They also renamed a few eCTD Module 1 sections:
- Section 126.96.36.199 eCTD element renamed from “m1-2-2-19-form-dmf-for-first-authorisation-variations” to “m1-2-2-19-form-dmf”
- Section 188.8.131.52 eCTD element renamed from “m1-2-2-20-form-inforation-quality” to “m1-2-2-20-form-information-qpplications-art-13-tpa”
- Section 1.5.1 eCTD element renamed from “m1-5-1-trial-information” to “m1-5-1-info-accord-appiv-guideline-bioequivalence”
- Section 1.7.6 eCTD element renamed from “m1-7-6-paragraph13adddoc” to “m1-7-6-article13adddoc”
- Section 1.2.2 eCTD element renamed from “m1-2-2-ann-form” to “m1-2-2-form-add”
More importantly, there are some instructions in the guidance that should make life easier, including eliminating a number that were required for Article 13 applications, and clarification that the cover letter is always submitted as “new” but any separate tracking table (after the first) will be a “replace” operation.
New areas in the submission have been created for two new forms:
- Section 184.108.40.206 added with eCTD element “m1-2-2-35-form-pip”
- Section 220.127.116.11 added with eCTD element “m1-2-2-26-gcpinspections”
The biggest change is the addition of Section 1.12 to handle Article 14 sect 1 letter abis-quarter, which determines how drugs with existing history in Europe or approved in Swiss cantons may be approved with an abbreviated application. A new eCTD element “m1-12-art14sec1letabisquater” has been added with four new leaf types:
- Applications including proof of EU/EFTA use for over 10 years with eCTD element “m1-12-1- eueftaauthorisation”
- Comparison with medications used in EU/EFTA with eCTD element “m1-12-2-eueftadocreference”
- Applications including proof of use for 30 years world-wide with eCTD element “m1-12-3-overallmedicaluse”
- Applications including proof of use within Swiss cantons for 15 years with eCTD element “m1-12-4-cantonalauthorisation”
Lastly, SwissMedic has added new application type values. Most of them are for variations , extensions and meeting advice matching those in the EU, but also new items for co-marketing and parallel imports.
It’s also good to see that the validation criteria appear to only have changed to include the new version 1.4 as valid, and there are no new validations.
RIM+ (from the team that created ARIM) Publisher, Validator, Viewer and Submission Planning modules have target releases for January 2019. as does the ACUTA Desktop Validator,. The exact release dates will be communicated in early December. The ARID (ACUTA Regulatory Intelligent Documents) template package is also planning an update containing SwissMedic document shells including the new Section 1.12 items, targeted for the end of 2018.
Please contact us if you would like more information on how IQVIA can assist with your eCTD publishing in Switzerland or elsewhere, using either our RIM+ software, or IQVIA submission services.