FDA's one-year progress report on the Generic Drug Cluster

The US Food and Drug Administration’s (FDA) Office of Generic Drugs has published  its first progress report on the activities and accomplishments of the  Global Generic Drug Affairs program’s Generic Drug Cluster. 

The Generic Drug Cluster is the first forum established for the world’s leading regulatory agencies to address generic drug development globally. The FDA and other leading regulatory agencies have participated in a series of meetings over the past year to collaborate on a number of regulatory topics. In an increasingly globalized pharmaceutical market, collaboration among drug regulators is key. Actions taken in one country or territory can impact the rest of the world. By working to harmonize procedural requirements where possible, regulatory agencies throughout the world can help streamline industry's efforts. 

The Generic Drug Cluster provides an unprecedented opportunity to achieve a common understanding of each agency’s regulatory requirements and to increase scientific information sharing and alignment. Meetings of the cluster take place via videoconference, and the information exchange is covered by confidentiality agreements among the agencies. FDA previously established clusters to discuss a variety of other agency issues such as biosimilars, medicinal cancer treatments, orphan drugs, pediatric medicines, and blood products.

The agencies involved in the Generic Drug Cluster cover a large population, so a systematic exchange of information and expertise can assist in deciding a best course of action on any given topic. For example, agencies often deal with complex drug safety issues at the same time as each other. The framework of the cluster allows the agencies to develop a deeper understanding of each other’s approach and actions in response to issues such as drug safety and shortages. Overall, greater information sharing may improve the quality of information an agency has to consider in reaching decisions and may lead to better outcomes for patients. There is also a benefit to industry through increased collaboration among agencies. 

Read the progress report to learn more.