FDA, EMEA agree on joint genomic data submissions

LONDON—To bridge gaps in the regulatory processes on either side of the Atlantic, the European Commission (EC), European Medicines Agency (EMEA) and the US FDA announced they have agreed to a procedure for joint FDA-EMEA meetings with spon­sors about voluntary genomic data submissions (VGDS). Previously, the two agencies individually encouraged the submission of this data to ensure agency familiarity with the increasing role of phar­macogenomics in drug discovery.

 

The longer term goals of the submission process is to ensure that agencies develop new policies based on the best science, organi­zations build common approach­es to genomics in therapeutics development, and to eventually incorporate the data into global drug development. This last point is particularly key as regulators begin to encourage drug compa­nies to codevelop therapeutics and diagnostic assays.

 

In the May 2005 issue of Drug Discovery News, Dr. Felix Frueh, associate director of genomics at the FDA's Center for Drug Evaluation and Research (CDER), explained the FDA's thinking about VGDS: "You might have exploratory data that was used in development that is of great interest to us so that we can get familiar with that type of information. This gives sponsors an opportunity to learn about how the FDA is thinking and facili­tate the movement forward of the development process."

 

Whereas companies have his­torically produced VGDS for each agency separately, with the concomitant need for meetings, reports, and responses, the com­panies now provide both agencies with a single VGDS and it will be the agencies that hold a joint meeting and file a joint report. Superficially, the two organiza­tions have streamlined the regu­latory process, but perhaps more important to drug companies is that the new process will provide a common regulatory ground—a single playing field, if you will—from which the agencies can work with companies to facilitate drug approval.

 

Via its press office, the EMEA offered its perspective on these col­laborative efforts, suggesting that they are a response to the increas­ing globalization of the pharma­ceutical industry and give the two leading regulators the ability to speak to each other and exchange information. The Europeans are quick to stress, however, that the two agencies have independent regulatory frameworks and the confidentiality arrangements are a tool for both agencies to better carry out their respective man­dates to promote and protect pub­lic and animal health.