| Popis: |
There have been efforts to harmonize, at an international level, regulatory requirements and expectations for the marketing authorization of medicinal products. This was for various purposes, including to streamline product development and to assure standards of quality and safety are universal. This chapter will discuss two of these major efforts—one being that of the International Council for Harmonisation (ICH) and the other being that of the World Health Organization (WHO). When harmonization is not possible because of varying legislative frameworks, then regulatory convergence is an appropriate goal. The processes followed by the ICH and WHO will be described, as well as their purposes and how they attempt to achieve international convergence on regulatory expectations to permit the registration of medicinal products in countries across the globe. |
