Agreement will speed drug approvals

Pharmaceutical Representative

New drugs will reach patients sooner as a result of a new agreement between the United States and the European Union.

New drugs will reach patients sooner as a result of a new agreement between the United States and the European Union.

The Mutual Recognition Act removes various regulatory barriers for a wide range of products, including pharmaceuticals.

The agreement was developed primarily by the U.S. Food and Drug Administration, the U.S. Department of Commerce and the European Commission, a governing office of the European Union.

According to the agreement, the United States and participating European countries will recognize each others' inspections of pharmaceutical manufacturing facilities. This agreement will reduce costs for governments and manufacturers and ultimately translate into fewer delays in the availability of new medicines.

Previously, inspectors from each jurisdiction had to inspect every factory where an imported drug was manufactured.

Awaiting cures

"At a time when patients everywhere are waiting for cures for AIDS, Alzheimer's, cancer and a host of other diseases, this agreement will help get new treatments to patients fast," said Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, in support of the cooperative effort.

"The money saved by avoiding duplication of effort can be used to increase research on cures for currently incurable diseases," Holmer said. PR