November 7, 2016
A new working group on rare diseases has been established through a collaboration among the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) in order to boost medicine development for rare diseases.
The aim of this new cluster will be too share experiences and best practices on each other’s regulatory approach to the development of medicines for these diseases, always assuring a secure exchange of information covered by the confidentiality arrangements between the two regulators. The agencies will exchange information on various aspects of the development and scientific evaluation of medicines for rare diseases. These include topics such as:
The cluster will provide a forum for confidential exchange of draft documents, policies under development, and more detailed information supporting the scientific basis for decision making on medicine development.