14.11.2014
On 15 November 2014, the new versions of the following guideline documents will be published on the Swissmedic website:
- Guidance for Industry on Providing Regulatory Information in eCTD Format v1.6
New chapters have been added to the Guidance for Industry as a result of the incorporation of the content of the Q&A document. In addition, chapters 3.1, 3.1.2, 4.7, 4.9, 5.2. and 7.3, as well as Appendix 2, have been revised or had information added to them. - Guidance on applications according to Paragraph 13 TPA for eCTD applications v1.2
The Guidance on applications according to Paragraph 13 TPA has had the content of the Q&A document added to it and been brought into line with the new administrative ordinance Instructions Authorisation of human medicinal products already authorised in foreign countries (Art. 13, TPA). - Questions & Answers of Swissmedic eCTD Implementation v1.9
The Q&A document has been substantially slimmed down and its contents have been transferred to the Guidance for Industry and the Guidance on Paragraph 13 TPA. As a result, the Q&A only contains updates on the Swiss M1 Specification for eCTD and new questions.
The Swiss M1 Specification for eCTD has been editorially revised, but there has been no version update.
Process modification: The Technical Validation process has been simplified. The Technical Validation Part I form will no longer have to be submitted in future. However, Swissmedic will continue to provide a slimmed-down version (1 page) to give applicants the option of providing comments on the sequence. In future, applicants will only be informed in writing of the outcome of technical validation if their application is rejected. This will usually be within 10 days of their application being received.