21 May 2012
Exalon: Swissmedic releases version 1.4 of their national "Q&A of Swissmedic eCTD Implementation
The Swiss national drug regulatory agency Swissmedic has released an updated version of their "Questions & Answers of Swissmedic eCTD Implementation". The Q&A document "aims to address the commonly-asked questions and provide guidance on Swissmedic's plans to implement electronic-only submissions with eCTD".
The Q&A is intended to be a "living" document, thus Swissmedic encourages applicants, other regulators, consultants and vendors to give feedback.
The new version of the Q & A document (clean and Marked) avilable in the below mentioned weblink