FDA and EMA Seek Candidates for GMP Inspection Pilot

Aug 19, 2010

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug-manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

A new EMA release states that companies that have submitted two separate but equivalent new drug application applications to EMA and FDA are eligible to participate in the pilot. Such companies will be inspected jointly by the regulatory agencies. In addition, if a company is expecting a routine surveillance or re-inspection by both agencies, that company can also participate in the pilot by hosting a single joint inspection.

“The overall objective is to see whether greater international collaboration can help to distribute inspection capacity allowing more manufacturing sites to be monitored and reducing unnecessary duplication,” says the EMA release.

Over the past couple of years, the agencies have conducted similar pilot programs. FDA, EMA and the Australian drug regulatory agency conducted an 18-month joint pilot inspection program focused on active pharmaceutical ingredient manufacture in countries outside of the three regions. This pilot officially began in November 2008. FDA and EMA ran a joint inspection pilot program of companies manufacturing drugs in both regions beginning in the spring of 2009 in order to better share information. The two agencies also ran an 18-month joint good clinical practices initiative starting in September 2009 to increase collaborative efforts to inspect clinical trial sites and studies.

The new GMP pilot program that is getting underway is meant to build on these experiences. Companies interested in the pilot should contact their respective agency at CDERInternationalGMP@fda.hhs.gov or gmp@ema.europa.eu.