Dr R. Spang, Switzerland

For many years, the IntercantonaI Office for Medicines Control (IOCM) has accepted registration submissions using the EU format for documentation and we have amended the Swiss regulations to accommodate this as the standard format for new chemical or biologically active substances. We have already implemented the ICH guidelines in Switzerland, which shows our commitment to the ICH harmonization process.

The Helvetic Confederation, a country with four national languages, is - to my knowledge - the only country where registration submissions are accepted in four languages: the three main Swiss languages plus English. Unfortunately, for the third ICH partner, Japan, we cannot accept submissions in Japanese.

Now with the CTD under discussion within ICH, the European Free Trade Association has delegated a person to participate in the ICH Expert Working Group dealing with efficacy. This will be a further advantage, as we will be informed about the state of discussions among the three regions.

With regard to a likely impact for Switzerland, if the three regions harmonize the structure of a registration submission dossier, then I am convinced that the IOCM will accept submissions using the ICH-CTD format. I would even expect that when we draft new regulations - something we must do anyway - then we will implement the ICH-CTD format as the standard structure for a registration submission to be used by industry. The internal consequences of this will be that our assessors will have to adapt their way of working. Positive consequences will also accrue. The pharmaceutical industry will benefit from the harmonized CTD-structure. At the same time, our assessors will profit from that structure when they exchange information with colleagues in other drug regulatory authorities during the assessment of an application. Therefore, as a non-ICH country, I do not see major obstacles or expect negative implications to our work in assessing and registering new drugs.