Swissmedic includes more than their own guidelines and Swiss laws in their interpretation of what is “state of the art in science and technology”

When Swissmedic evaluates the application documentation within the framework of their guidance documents, it also takes into consideration – to support the evaluation and also as a reflection of the current status of science and technology – the currently valid edition of the Pharmacopoeia, the relevant Guidelines of the European Committee for Medicinal Products for Human Use (CHMP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), technical reports by the WHO or other guidelines listed in the annex of their guidance documents.

This information is given in section 5.1.1 of their guideline for New active substances and section 2 of their guideline for Known active substances and is based on Art. 2 of the Medicinal Product Application Ordinance (AMZV) – in German/French only.

On the Swissmedic, International collaboration page related to the international Council of Harmonisation (ICH), the implementation of the ICH guidelines by Swissmedic is described.

According to a publication in the Swissmedic Journal 5/2006, page 504 (In German only), ICH Guidelines are regarded as harmonised within the ICH process with adoption of step 4 and are considered as “state of the art in science and technology”.

What does Swissmedic mean by “state of the art in science and technology”?

Your contact