IS ICH EXPORTABLE OUTSIDE THE EUROPEAN UNION?

摘要

This article sets out to explore whether or not the International Conference on Harmonisation(ICH)Good Clinical Practices(GCP)Guidelines are exportable outside the European Union(EU).It is not a question of whether the Guidelines per se are exportable but rather can studies outside the EU be performed to the same,or a better standard?It is well known that the ICH Guidelines are accepted worldwide in the countries where International Clinical Trials are carried out. Likewise with the signatoriesto the Step 5 document being the major players-the USA,Japan,and Europe-the guidelines are already enshrined in national legislation. The author therefore sets out to address whether clinical trials can be conducted to the ICH GCP standard outside Western Europe.The facts and opinions presented here are based on a 16 centre(of which eight of the centres were required to be audited by the Sponsor)clinical study that was carried out in both the Czech Republic and Poland for nonseasonal rhinitis.The recruitment of patients was required to take place in a short period of time and had strict inclusion and exclusion criteria.The overall concept of the study and the compliance with internationally accepted ICH GCPs was found to be of a very high standard.In addition, several other studies from totally different therapeutic areas,clearly show that the standard in non-EU countries is equally high and in most cases of a higher standard than is seen at the principal investigators sites wihtin the EU. In what Western Europeans like to call" developing countries," an understanding of the international GCPs has already been grasped and extremely high quality clinical trials are being carried out. To demonstrate this,attention is drawn to a large head and neck cancer study that was part device and part pharmaceutical product and was conducted in conjunction with photodynamic therapy(PDT),carried out in several countries, but of note in India.