Because drug development and approval happens across the globe, and not in one single country or region, collaboration among international regulatory agencies is hugely important. Recognizing this, agencies across Europe, North America, Japan and Australia have been working together, for over a decade, to solve some of the world’s biggest health challenges.
These organizations work together in groups called clusters. “The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.”
According to the European Medicines Agency’s (EMA) Executive Director, Guido Rasi, “in an increasingly globalised pharmaceutical market, collaboration between medicines’ regulators is essential. Medicines’ regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world”.
The first cluster was created back in 2004 to facilitate the sharing of clinical review information from clinical trials for promising, new cancer medications. Since then, clusters have been formed to focus on topics including pediatric drugs, biosimilar and generic drugs, pharmacovigilance, orphan medicinal products, vaccines, patient engagement, etc.
The most recent cluster was created in September of 2016 to help advance treatments for patients with rare diseases. Currently, the only two members of this cluster are the EMA and the US FDA. The primary goal of the cluster is to encourage EMA and FDA researchers to share important information about their ongoing work and to allow them to collaborate on certain review aspects of promising rare disease drug development programs.
It is important to note that, although the clusters allow member agencies to develop a deeper understanding of each other’s approaches and actions in a given space, the formation of a cluster does not require the agencies to arrive at identical regulatory decisions. There are important differences in agency practices as well as in regional healthcare systems and, as such, different courses of action are often required.
For more information on each of the clusters, visit the EMA website.