Swissmedic launches the public consultation on Guideline Q5A(R2) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 10 February 2023 for comments
Public consultation on ICH Guideline Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin” launched in Switzerland
28.11.2022
Stakeholders in Switzerland have until 10 February 2023 to comment on the draft of Guideline Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin”. Compared to Guideline Q5A(R1), Q5A(R2) includes additional recommendations on controlling viral contamination of biotechnology products to reflect new biotechnology product types, advances in manufacturing technology, analytical methods for virus testing, and scientific knowledge that have occurred since publication of the original document in 1999. Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: