In recognition of the pressures facing generic drug review programs as a result of the ever increasing numbers of marketing applications, the complexity of products and challenges associated with globalization, the Consortium has selected generic drug review as a priority area for collaboration.
The Consortium has initiated a comprehensive and proactive plan of action that includes the sharing of reviews, staff exchanges and identifying opportunities for convergence. Such work is in alignment with arrangements in place under each agency’s legislative framework for sharing information with other regulatory authorities.
Activities undertaken by the Consortium will lead to the convergence of regulatory requirements and approaches, more efficient use of available resources, reduction in regulatory burden and duplication of effort, improve application approval times and greater availability of generic drugs for patients. This should in turn have a positive influence on public health care systems.
It is expected that the work of the Consortium will serve as a "proof of concept" for broader international initiatives underway in this area.
Further information will be available on this important joint effort in the near future.